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Client Engagement Specialist

About EMMA International

E.M.M.A. International Consulting Group, Inc. is a global leader in management consulting services, with headquarters in Farmington Hills, Michigan, as well as offices in Florida, Pennsylvania, and North Carolina. We focus on quality, regulatory, and compliance services for the Biotechnology, Pharmaceuticals, and Medical Device industries.

 

Summary

The Client Engagement Specialist will be responsible for maximizing sales and profitability through relationship development with potential and/or current clients for our quality system and regulatory compliance services. With the aid of E.M.M.A. International operations and consulting personnel, the incumbent will establish and manage relationships with clients through initial outreach and follow up.

 

Essential Duties and Responsibilities

  • Develop new business leads to achieve sales goals.
  • Utilize prospecting and research tools to connect 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 E.M.M.A. International CRM system.
  • Reach and/or exceed daily and weekly lead generation goals.
  • Performs other related duties as required or assigned.

 

Knowledge, Skills and Abilities

  • 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.

 

Minimum Requirements

  • Associate’s degree in Marketing, Sales, Business Management.
  • 2+ years in sales, marketing and/or telemarketing experience.
  • Knowledge and experience working in the Life Sciences industry, a plus.

 

Physical Demands and Working Conditions

  • Ability to operate a computer and work at a desk for extended periods of time.
  • Minimal physical effort will be required in this position.

 

Location

Raleigh, North Carolina (no relocation assistance available). Work days are Monday – Friday in an office environment.

Quality Engineer

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

Software Quality Engineer

About EMMA International

E.M.M.A. International Consulting Group, Inc. is a global leader in management consulting services, with headquarters in Farmington Hills, MI, as well as offices in FL & PA. We focus on quality, regulatory, and compliance services for the Biotechnology, Pharmaceuticals, and Medical Device industries.

 

Summary

The Software Quality Engineer will be responsible for effectively managing all aspects of QualiPro, an Enterprise Quality Management Software (EQMS) offered exclusively by EMMA International through our partnership with Saphir Consult. QualiPro is an end-to-end quality management software suite that will ensure that your business follows U.S. and international standards, regardless of the industry. QualiPro helps facilitate the implementation of integrated quality management processes by providing you with a world class EQMS that is cost effective, interactive, and user-friendly. For more information, visit www.emmainternational.com.

 

Essential Duties and Responsibilities

  • Provide product demos.
  • Effectively educate and engage customers to solutions leveraging QualiPro’s benefits leading to competitive conversions.
  • Ensure regulatory compliance for all IT-related activities including new implementations, validations and documentation review.
  • Work with internal & external teams on configuration management and customization of the software to reflect the customer requirements
  • Work with the software developer and the internal technical team on all related software upgrades
  • Serve as a liaison for all QualiPro related issues
  • Triage issues, problem solve and follow up accordingly to ensure customer satisfaction.

 

Knowledge, Skills and Abilities

  • In-depth knowledge of enterprise quality management software tools
  • In-depth expertise in cGMPs, 21 CFR part 11, 21 CFR Part 820, and ISO standards
  • Ability to communicate effectively in writing, in person, over the telephone and in e-mail
  • Ability to quickly learn technical skills
  • A proven track record in understanding the process of specifying, identifying and implementing EQMS applications will be as essential
  • Having the know-how in software development and testing methodologies
  • Familiarity with global regulations and guidance documentsExperience with gathering requirements, performing business analyses and managing user relationships
  • Strong understanding of Life Sciences, Medical Device and Manufacturing industries
  • Customer Service experience and training
  • Strong understanding of manufacturing regulations preferred
  • Goal-oriented focus, excellent time management skills and great work ethic
  • Must be a motivated team player and flexible with regards to duties and working hours
  • Willingness to travel

 

Minimum Requirements

  • BA/BS required
  • 10+ years of experience in quality system management, compliance, validation or another quality role within the medical device or pharmaceutical industry
  • Strong leadership and presentation skills
  • Strong understanding of MS Office applications

 

Physical Demands and Working Conditions

  • Ability to work non-standard hours
  • Extensive travel required
  • Ability to operate a computer and work at a desk for extended periods of time

If you’re interested in a career in quality and compliance, please send a Cover letter and Resume to: careers@emmainternational.com.

Want to be a consultant?

Our team includes more than full-time staff members. We’d love to have you on our team of expert compliance consultants who help our clients navigate the complex work of compliance. Our consultants work in medical devices, pharmaceuticals, biologics, and more.

 

Please fill out our consultant questionnaire so we can learn more about you.