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.

Executive Assistant

    Full-Time (On-Site)
    Bingham Farms, MI

Position Summary

This position will support all daily business administrative and coordination responsibilities for the management team, including calendar management, preparation of reports and presentations, management and submission of various lists and reports, arranging meetings, tracking expenses and arranging travel, and performing special projects as required.

Essential Duties 

  • Manage the reception area to ensure effective telephone and mail communications both internally and externally to maintain professional image.
  • Manage the management team’s calendar.
  • Arrange and coordinate travel for CEO and assist with travel for other team members as needed.
  • Coordinate and prepare materials for Management Review meetings.
  • Responsible for office management including keeping the office and conference rooms clean, ensuring kitchen & break areas are stocked with supplies, opening the office in the morning, ordering and maintaining office supplies, etc.
  • Employee relationship engagement
  • Liaison between clients, candidates and contractor workers
  • Maintain confidentiality in all aspects of client, staff, and agency information.
  • Work directly with the Director of Business Development and Manager of Technical Operations to maintain status of marketing materials. Will also be responsible for mass mailing initiatives. This includes management of firm Social Media, public image, various organizational memberships, etc.
  • Submit and reconcile expense reports.
  • Coordinate travel & expense logistics for team members & other project contractors. This position works directly with both the Business Development & Technical Operations functions to support this initiative.
  • Assist in training team members and new hires. This includes preparation of new hire documentation, supplies, and coordinating schedules.
  • Maintain contact lists.
  • Ensure operation of equipment by completing preventive maintenance requirements; calling for repairs; maintaining equipment inventories; evaluating new equipment and techniques.
  • Produce and distribute correspondence memos, letters, faxes and forms.
  • Assist in the preparation of regularly scheduled reports.
  • Negotiate the purchase of office supplies and furniture, office equipment, etc., for the entire staff in accordance with company purchasing policies and budgetary restrictions.
  • Responsible for taking all meeting notes.
  • Participate as needed in special departmental projects.
  • Maintain office vendor list, including portal login details & contact information.
  • Have other duties as assigned.

Qualifications

  • Good oral and written communication skills
  • Knowledge of Microsoft Office suite
  • This is not an exhaustive list of qualifications

Education

  • Associates in Administrative, business, or comparable

Working Conditions

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

Quality Engineer

    Full-Time (On-Site)
    Bingham Farms, MI

 Company Overview

EMMA International Consulting Group, Inc. is a global leader in management consulting services, with headquarters in Bingham Farms, Michigan.  We focus on quality, regulatory, and compliance services for the Biotechnology, Pharmaceuticals, and Medical Device industries.

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.

 Essential Duties

  • 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.

Qualifications

  • 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.
  • This is not an exhaustive list of qualifications

Education

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.

Working Conditions

  • 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.

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

As a consulting firm, EMMA provides with hands-on GMP consulting, quality and compliance services to medical device, pharmaceutical, and biotech industries. The one thing I have liked the most about working for EMMA is the work environment. For its clients and employees, team EMMA is a family before anything else, where the focus is both on personal and professional growth. With EMMA, every day is exciting!
Kanika Kalra
Regulatory Affairs Specialist
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 Green
Director of Technical Operations
I’m blessed to be a part of the supportive, hard-working, and efficient team at EMMA International. No matter how busy it gets, someone on the team is happy to help. It’s always an exciting day here, collaborating to solve problems, big and small, with a family-like team at EMMA International.
Jenifer Kang
Quality Engineer
Working with EMMA International has been a hit-the-ground-running adventure!  Within the past two months, I was able to help develop QMS procedures for two clients, augment the Regulatory staff of another client to help with their EU MDR technical documentation, and author a half dozen quality-related posts for the EMMA Blog. I can hardly wait to see what comes next.
Diane Kulisek
Senior Quality Engineer
While working at EMMA International, every day is a learning experience. Everyone is always willing to support each other in any way possible. EMMA fosters an environment of growth and respect, where I know my input is valued.
Josie Zepeda
Marketing and Operations Specialist

Pin It on Pinterest