Join Our Team of FDA Experts

Working for EMMA International means working in a fast-paced, team-centric environment. You will be a part of a hard-working, passionate, and motivated team who is dedicated to achieving collective goals. Being a successful part of the EMMA International team means being dependable, self-driven, and a team-player with a strong work-ethic. If you are a critical-thinker who is looking for an employer to grow with, EMMA International is the place for you!

To apply for a job listed, please send a cover letter and resume to careers@emmainternational.com.

Become a Consultant

EMMA International uses consultants for a variety of different projects and we are always looking for consultants to be considered for new projects. To become a consultant, fill out the consultant questionnaire.

Customer Engagement Specialist

    Full-Time (Detroit, MI/Remote)

    Essential Duties

    • Develop new business leads to achieve sales goals.
    • Cultivate strong business relationships with key decision makers.
    • Proactively identify new opportunities and deliver innovative solutions to customers.
    • Develop market strategies by researching lists of high potential prospects.
    • Utilize prospecting and research tools to contact new leads and qualify opportunities.
    • Strategize with team members to innovate and improve the overall inside sales process.
    • Follow-up and place outgoing calls with various lead types received.
    • Accurately obtain and record client information into the EMMA International CRM system.
    • Source and recruit candidates by using databases, social media …etc.
    • Screen candidates resumes and job applications.
    • Conduct interviews using various reliable recruiting and selection tools/methods to filter candidates within schedule.
    • Reach and/or exceed daily and weekly lead generation goals.
    • Performs other related duties as required or assigned.

    Qualifications

    • Ability to follow systemized processes and scripts.
    • Effective time management skills to prioritize daily activities that result in greater lead generation results.
    • Must be a self-starter with a determined, goal driven and persistent personality.
    • Ability and desire to work as a motivated team player in a collaborative environment.
    • Excellent verbal communication skills and telephone manner.
    • Knowledge and experience working in the Life Sciences industry, a plus.
    • This is not an exhaustive list of qualifications.

    Education

    • Bachelor’s degree in Marketing, Sales, Business Management. Pending degree status will be considered.
    • 2+ years in sales, marketing and/or telemarketing experience preferred.

    Working Conditions

    • The work will be performed in an office environment.
    • Minimal physical effort will be required in this position.
    • Workdays: Monday – Friday, 8:00 a.m. – 5:00 p.m.

      Quality Engineer

      Full-Time (Detroit, MI)

      Position Summary 

      Responsible for the development, maintenance, and implementation of specifications and standards for processes, materials, and products in accordance with quality programs, plans, SOPs and policies of the company’s Quality System and in compliance with FDA regulations, ISO 13485, and other regulatory requirements as applicable.

      Qualifications

      BS or MS degree in technical/scientific/engineering discipline, with at least 2+ years of experience in medical devices, in vitro diagnostics or a related industry. Experience developing and implementing quality plans and programs. ASQ certification (CQE, CRE) is preferred. Working knowledge and experience of FDA’s Quality System requirements (QSR), ISO 9001 and ISO 13485 standards. Ability to coordinate multiple project schedules and activities.

      The candidate should have strong analytical, communication and interpersonal skills. Strong linguistic, grammar, and editing skills. Ability to multi-task in an environment with changing priorities. Strong statistical training, skills and experience.

      Proficiency with Microsoft applications Word, Excel, Project, Visio, and PowerPoint. And ability to learn additional software applications, as the need arises.

      Principal Duties and Responsibilities

      • Assist in the development, implementation, and maintenance of Quality System specifications and requirements in accordance with cGMPs, ISO 13485 and other International regulations as applicable.
      • Direct and/or participate in projects directed at the development and implementation of quality standards throughout the company.
      • Participate in department meetings to provide input into the design and implementation of product specifications.
      • Write, review and edit documents and SOPs as required.
      • Assist during FDA inspections, ISO Certification and surveillance audits and customer and supplier audits.
      • Assist in validation activities and development of requirements and specifications.
      • Follow-up on corrective action responses, ensuring implementation of appropriate problem resolution methods and verifying effectiveness.
      • Facilitates problem-solving activities, team building and quality systems tools and methodologies.
      • Collaborate with other departments and functions on continuous improvement opportunities of the Quality System.
      • Carry out other duties as required or assigned

      Quality Engineer II

      Contract (Remote)

      Position Summary 

      Responsible for the development, maintenance, implementation and oversight of specifications and standards for processes, materials, and products in accordance with quality programs, plans, SOPs and policies of the company’s Quality System and in compliance with FDA regulations, EU MDR, ISO 13485, ISO 14971, and other regulatory requirements as applicable.

      Qualifications

      BS or MS degree in technical/scientific/engineering discipline, with at least 4+ years of experience in medical devices, in vitro diagnostics or a related industry. Experience developing and implementing quality plans and programs. ASQ certification (CQE, CRE) is preferred. Working knowledge and experience of FDA’s Quality System requirements (QSR), ISO 9001 and ISO 13485 standards. Ability to coordinate multiple project schedules and activities.

      The candidate should have strong analytical, communication and interpersonal skills. Strong linguistic, grammar, and editing skills. Ability to multi-task in an environment with changing priorities. Strong statistical training, skills and experience.

      Proficiency with Microsoft applications Word, Excel, Project, Visio, and PowerPoint. And ability to learn additional software applications, as the need arises.

      Principal Duties and Responsibilities

      • Assist in the development, implementation, and maintenance of Quality System specifications and requirements in accordance with cGMPs, ISO 13485 and other International regulations as applicable.
      • Direct and/or participate in projects directed at the development and implementation of quality standards throughout the company.
      • Participate in department meetings to provide input into the design and implementation of product specifications.
      • Write, review and edit documents and SOPs as required.
      • Facility and system oversight during FDA inspections, ISO Certification and surveillance audits and customer and supplier audits.
      • Interfaces with all departments with special regard to Quality Systems Regulations {ISO 9001, ISO 13485, ISO 14001 and QSR 21 CFR part 820}
      • Provides technical and logistical guidance and support for the Quality Engineering staff
      • Drives proactive participation with suppliers, and aids, when applicable, in their process improvement efforts
      • Interfaces and provides technical support on quality issues with the customer
      • Assist in validation and verification activities and development of requirements and specifications.
      • Follow-up on corrective action responses, ensuring implementation of appropriate problem resolution methods and verifying effectiveness.
      • Facilitates problem-solving activities, team building and quality systems tools and methodologies.
      • Collaborate with other departments and functions on continuous improvement opportunities of the Quality System.
      • Carry out other duties as required or assigned

      Research Analyst

      Full-Time (Multiple Sites)

      Position Summary 

      The Research Analyst collaborates with members of cross-functional teams to prepare high-quality protocols, investigator brochures, synopses, regulatory documents, clinical publications, and related clinical documents within agreed-upon timelines.

      Qualifications

      • A minimum of a Bachelor degree in medical-related field or life science.
      • Bachelor’s degree +4 years of experience, or Master’s degree and relevant medical writing experience in the pharmaceutical industry, nice to have experience in writing in one or more of the oncology diagnostic or gynaecological therapeutic areas
      • An understanding of the drug development process
      • Broad experience managing the medical writing responsibilities associated with multiple studies at various stages
      • Experience in interacting with cross functional study team members
      • Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing
      • Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details
      • Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately.
      • Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members

      Principal Duties and Responsibilities

      To perform this job successfully, an individual must be able to perform the following:

      • Prepares, edits, and finalizes protocols, investigator brochures, synopses, regulatory documents and related clinical documents, such as abstracts, posters, presentations, and manuscripts
      • Participates in scientific communication planning, including development of strategic medical communication plans
      • Partners with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for relevant documents
      • Works closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources.
      • Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
      • Collaborates with clinicians, clinical scientists, biostatisticians, and pharmacokineticists to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents
      • Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
      • Works closely with the study team to reach consensus on timelines for deliverables
      • Completes documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance
      • Understands the functions and roles within the study team and aligns with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations
      • Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines
      • Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables
      • Ensures documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in agreed document management system
      • Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements
      • Suggests or identifies changes, modifications, and improvements to the document preparation processes and templates in order to improve quality, efficiency, and productivity
      • Align with department management to set strategy for meeting department goals

      Qualifications

      • The work will be performed in an office environment.
      • Minimal physical effort will be required in this position.
      • Work days: Monday – Friday, 8:00 a.m. – 5:00 p.m.

      The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.

      Field Validation Engineer

      Full-Time (Multiple Sites)

      Location:

      • This is a site based position that works at customer site to ensure customer satisfaction by providing installation qualification, operational qualification and performance qualification (temperature mapping), that keeps equipment operating safely and reliably. Provides generalist level support to one or more product lines or applications. Actively promotes service offerings, new products, and upgrades.

      What will you do?

      • Performs technical diagnosis of operational problems and repairs/calibrations on wide range of laboratory equipment to ensure that the equipment is operating to the customer’s complete satisfaction and manufacture specifications. May include running the necessary experiments and/or coordinate among the in-house and outside experts to reach a resolution.
      • Performs technical evaluations on product changes and on new products, including software verification, collection of performance data, assessment of user friendliness, ease of maintenance, etc. Provide written reports on evaluations.
      • In addition to training end users and distributors, serves as a source of technical product knowledge and trains, as required, other service engineers and provides supervision as required in the course of this duty.
      • Conduct validation or qualification tests of new or existing equipment, or software in accordance with internal protocols or external standards
      • Prepare detailed reports based on results of validation and qualification tests.
      • Enters various types of data (i.e. service log, invoicing, knowledge retention, etc.) into both customers and computer systems
      • Ensures customer satisfaction through excellence in repair and support of customers’ products.
      • Maintains communication with customer to ensure understanding of status, cost, and timing of all aspects of the service event.
      • Provides courteous and knowledgeable response to technical issues, meeting commitments in a timely manner.
      • Serves as a customer advocate and ensures that technical issues are resolved in a timely manner
      • Manages escalation of unresolved technical issues to Technical Support
      • Supports the Customers and Quality Systems and Quality Policy’s by following procedures/work instructions and creating records to meet the requirements of the Quality System Regulation and ISO registration.
      • Maintains spare parts inventory, tools, manuals and test equipment.
      • Maintains records of all service events per organizational policy.
      • Promotes and sells various types of extended warranty/PM contracts on equipment, user training, and Service Replacement Orders
      • Advises sales representatives of potential selling opportunities within accounts

      Minimum Requirements/Qualifications:

      • ISO 17025 and related compliance knowledge
      • GxP and Good Documentation Practices
      • Working knowledge of Amphenol Kaye AVS temperature mapping instrumentation
      • 3 years of related QA or Validation experience
      • Demonstrated technical proficiency in instrumentation and electronics
      • Strong problem solving skills.
      • Strong verbal and written communication skills. Bilingual a plus but not required.
      • Proficient user of Microsoft Word, Excel and Outlook.
      • Up to 75% domestic travel
      • Ability to work overtime and/or outside regular business hours, and/or on-call work
      • Regularly lift and/or carry up to 30 pounds; and occasionally lift and/or carry 75+ pounds
      • Ability to bend, squat, stretch, and reach on a daily basis in a service function.
      • Maintain a valid driver’s license and safe driving record

      Preferred Qualifications:

      • Experience supporting laboratory equipment (may include, but not limited to, centrifuges, incubators, refrigeration, ultra low freezers).
      • Experience working in a Warehouse, Laboratory and Clean Room Environments.
      • Clean Room Gowning Procedures
      • Kaye AVS Validation
      • ISO 9001 and ISO 17025 Calibration Experience
      • GxP and GDP experience

      Typical Knowledge, Skills, and Abilities:

      • Strong problem solving skills.
      • Proficient verbal and written communication skills. Bilingual a plus but not required (Spanish, Mandarin) . Demonstrated organizational skills; ability to handle multiple priorities.
      • Strong inter-personal, self-motivational, & negotiating skills

      Physical/Environmental Requirements:

      While performing the duties of this job, the employee is frequently required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; talk or hear; and taste or smell. The employee is occasionally required to climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or carry up to 30 pounds, frequently lift and/or move up to 75+ pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

      Specific job duties that require the physical demands itemized above include driving to a customer site, talking to customers on the phone and in person, working on customer equipment, reading schematics, repairing instrumentation, reading color coding on resistors, writing service reports and expense reports, and installing instrumentation.

       

      Work Environment

      The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

        Sr. Process Development Technician

        Contract (St. Louis, MO)

        Position Summary 

        This is a hands-on position requiring equipment setup, modifications, and operations. Duties may include, but are not limited to, lay out, the build, test, troubleshoot, repair, and modification of developmental and production components, parts, equipment, and systems. 

        Qualifications

        • A minimum of a Bachelor degree in an engineering or medical-related field.
        • Bachelor’s degree +5 years of experience, or Master’s degree +2 years of experience.  
        • Experience in interacting with cross functional team members
        • Knowledge of machine controls and support equipment
        • Ability to work safely around heavy machinery and heavy equipment
        • Ability to work with people in a pro-active manner
        • Ability to work unsupervised
        • Ability to work independently with minimal supervision, multi-task, and work effectively under pressure; adapt to change as needed; possess excellent project management skills; attentive to details
        • Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed timelines; monitor and communicate progress against milestones; escalate complex issues appropriately
        • Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members
        • Experience in the Pharmaceutical manufacturing space, including active ingredient manufacturing and final dose form

        Principal Duties and Responsibilities

        To perform this job successfully, an individual must be able to perform the following:

        • Generates detailed work instructions or standard work plans for processes including: production start-up, production shut-down, equipment change, equipment cleaning, equipment installation or removal, and general equipment maintenance
        • Participates in scientific communication planning, including development of strategic communication plans
        • Writes instructions and trains personnel in proper techniques to utilize systems, equipment, and processes
        • Assists in new process, product, and material development with guidance from the R&D, Innovation and Product Management teams
        • Helps to propose, vet, develop, and implement small improvements for the purpose of mistake-proofing, safety, visual management, or general ‘Lean’ principles
        • May often be assigned to complete tooling changes as part of development trials
        • May often be assigned to complete tooling removal or installation in association with an overhaul
        • Between overhauls, identifies and communicates deficiencies that are found, on an ad-hoc basis, so that they can be added to a backlog and tracked
        • Sets up and runs experiments and/or test apparatus
        • Designs, recommends, assembles and installs apparatus and processes for product fabrication, research and development or analysis and testing
        • Analyzes data, evaluates systems and processes and makes decisions regarding modifications, if necessary
        • Writes technical reports and other required documentation
        • Interacts with and advises other departments
        • Ensures documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in agreed document management system
        • Ensures that appropriate documented quality control (QC) checks are performed on deliverables, responds to findings, and recommends quality process improvements
        • Suggests or identifies changes, modifications, and improvements to processes in order to improve quality, efficiency, and productivity
        • Operates in a manner that provides value to the team

        Work days: Monday – Friday, 8:00 a.m. – 5:00 p.m.

          The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.

          Director of Finance

          Bingham Farms, MI

          Position Summary 

          The Director of Finance will be responsible for financial planning and strategy, and internal financial operations. With the aid of EMMA International operations and consulting personnel, the incumbent will oversee both internal and external financial operations.

          Qualifications

          • Bachelor’s degree in Business Administration, Accounting, or Finance required. Master’s degree preferred.
          • Ability to follow systemized processes and scripts.
          • Excellent analytical and organizational skills.
          • Proficient in database and accounting computer application systems.
          • Excellent written and verbal communication skills.
          • Knowledge and experience working in the Life Sciences industry, a plus.
          • This is not an exhaustive list of qualifications

          Principal Duties and Responsibilities

          To perform this job successfully, an individual must be able to perform the following:

          • Directs the preparation of all financial statements, including income statements, balance sheets, shareholder reports, tax returns, and governmental agency reports.
          • Compares sales and profit projections to actual figures and budgeted expenses to actual expenses; makes or oversees any necessary adjustments to future projections and budgets.
          • Reviews planning process and suggests improvements to current methods.
          • Works with the CEO and management team to coordinate planning and establish priorities for the planning process.
          • Studies long-range economic trends and projects their impact on future growth in sales and market share.
          • Identifies opportunities for expansion into new product areas.
          • Oversees investment of funds and works with investment bankers to raise additional capital required for expansion.
          • Implements, maintains, and reviews payroll processing systems to ensure timely and accurate processing of payroll transactions including salaries, benefits, garnishments, taxes, and other deductions.
          • Ensures accurate and timely processing of payroll updates including new hires, terminations, and changes to pay rates.
          • Prepares and maintains accurate records and reports of payroll transactions.
          • Ensures compliance with federal, state, and local payroll, wage, and hour laws and best practices.
          • Facilitates audits by providing records and documentation to auditors.
          • Performs other duties as assigned.
          • Responsible for all Accounts Receivable functions
          • Other duties as assigned

            The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.

            Working Conditions

            • This position is a hybrid position.
            • The work will be performed part-time in an office environment.
            • Minimal physical effort will be required in this position.
            • Workdays: Monday – Friday, 8:00 a.m. – 5:00 p.m.

            To apply for a job listed, please send a cover letter and resume to careers@emmainternational.com.

            Here at EMMA International, I felt immediately welcomed like I would be as if I was walking through the front door to my family. I found myself with an amazing organization, doing something that challenges me, and progressing through my career professionally and personally. I have found endless opportunities to be creative, innovative, and collaborative with my teammates, which was an important aspect for me when finding my first job after graduating.
            Abby McVay
            Research Analyst
            I could not have asked for a more supportive, understanding, and flexible work environment that enables me to reach my career goals and apply my skill set to the industry. Being a part of the EMMA team is a satisfying, collaborative experience that continues to teach me something new everyday.
            Kareem Arafat
            Quality Engineer
            I am excited to work at EMMA International for the opportunity to expand my knowledge base and expertise in the quality and regulatory compliance industry across multi-faceted medical applications. At EMMA, I can embrace the ability to learn all of the factors that assist with bringing medical devices, pharmaceuticals, and biotech products to market.
            Zach Nies
            Quality Engineer (Co-Op)
            It’s never a dull day at EMMA International! This team truly strikes the perfect balance between providing a support system and allowing for individual autonomy to accomplish goals. I love being able to find solutions for a wide variety of problems across various clients and projects. I also love that I work with a team of people who are driven, excited, and committed to overall success.
            Madison Wheeler
            Manager of Technical Operations

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