ECI
Design Quality Manager Consultant
ECI’s mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long‑term value. ECI boasts a proven track record of providing full product life‑cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment and benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.
About The Role The main responsibilities of the Design Quality Manager Consultant include, but are not limited to, providing quality oversight and strategic leadership for design and development activities within the medical device lifecycle. The ideal candidate will ensure compliance with regulatory and quality standards, foster collaboration across R&D, Quality, and Regulatory teams, and drive continuous improvement in design processes and documentation.
What You’ll Do
Provide independent quality oversight for design and development activities.
Ensure compliance with Design Control requirements per 21 CFR 820.30 and ISO 13485:2016.
Review and approve Design History Files (DHF), Risk Management Files, and associated documentation.
Lead or facilitate cross‑functional Design Reviews ensuring traceability and risk alignment.
Evaluate and update design‑related procedures, templates, and work instructions.
Support MDSAP, MDR/IVDR, and ISO 14971:2019 compliance activities and audits.
Oversee risk management, ensuring consistent hazard identification and mitigation strategies.
Partner with Regulatory Affairs to ensure design documentation supports regulatory submissions (510(k), CE, etc.).
Conduct internal and supplier audits specific to design and development quality.
Review and approve Verification & Validation (V&V) plans and reports for accuracy and compliance.
Support CAPA investigations, complaint handling, and change control related to product design.
Mentor and train design and engineering teams on quality system and regulatory expectations.
Drive continuous improvement initiatives and contribute to digital QMS / PLM enhancements.
Other ad hoc duties as assigned.
What You Will Bring
Bachelor’s or Master’s degree in Engineering, Life Sciences, or Quality Management.
8+ years of experience in medical device design quality, design assurance, or development quality.
Strong working knowledge of FDA QSR (21 CFR 820), ISO 13485, ISO 14971, MDSAP, and EU MDR/IVDR.
Demonstrated experience managing Design Controls, Risk Management, and DHF maintenance.
Experience supporting Regulatory Submissions (510(k), Technical Files, PMA).
Prior consulting or contract experience in a regulated environment preferred.
Familiarity with eQMS/PLM tools such as Greenlight Guru, MasterControl, Arena, or Veeva.
Excellent communication, analytical, and leadership skills.
ASQ CQE or Six Sigma certification preferred.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance
Industries Business Consulting and Services
Referrals increase your chances of interviewing at ECI by 2x
All qualified applicants will receive consideration for employment at ECI without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital or citizenship status, or any other status protected by law.
At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment‑based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.
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About The Role The main responsibilities of the Design Quality Manager Consultant include, but are not limited to, providing quality oversight and strategic leadership for design and development activities within the medical device lifecycle. The ideal candidate will ensure compliance with regulatory and quality standards, foster collaboration across R&D, Quality, and Regulatory teams, and drive continuous improvement in design processes and documentation.
What You’ll Do
Provide independent quality oversight for design and development activities.
Ensure compliance with Design Control requirements per 21 CFR 820.30 and ISO 13485:2016.
Review and approve Design History Files (DHF), Risk Management Files, and associated documentation.
Lead or facilitate cross‑functional Design Reviews ensuring traceability and risk alignment.
Evaluate and update design‑related procedures, templates, and work instructions.
Support MDSAP, MDR/IVDR, and ISO 14971:2019 compliance activities and audits.
Oversee risk management, ensuring consistent hazard identification and mitigation strategies.
Partner with Regulatory Affairs to ensure design documentation supports regulatory submissions (510(k), CE, etc.).
Conduct internal and supplier audits specific to design and development quality.
Review and approve Verification & Validation (V&V) plans and reports for accuracy and compliance.
Support CAPA investigations, complaint handling, and change control related to product design.
Mentor and train design and engineering teams on quality system and regulatory expectations.
Drive continuous improvement initiatives and contribute to digital QMS / PLM enhancements.
Other ad hoc duties as assigned.
What You Will Bring
Bachelor’s or Master’s degree in Engineering, Life Sciences, or Quality Management.
8+ years of experience in medical device design quality, design assurance, or development quality.
Strong working knowledge of FDA QSR (21 CFR 820), ISO 13485, ISO 14971, MDSAP, and EU MDR/IVDR.
Demonstrated experience managing Design Controls, Risk Management, and DHF maintenance.
Experience supporting Regulatory Submissions (510(k), Technical Files, PMA).
Prior consulting or contract experience in a regulated environment preferred.
Familiarity with eQMS/PLM tools such as Greenlight Guru, MasterControl, Arena, or Veeva.
Excellent communication, analytical, and leadership skills.
ASQ CQE or Six Sigma certification preferred.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance
Industries Business Consulting and Services
Referrals increase your chances of interviewing at ECI by 2x
All qualified applicants will receive consideration for employment at ECI without regard to race, creed, color, religion, national origin, sex, age, disability, sexual orientation, gender identity or expression, genetic predisposition or carrier status, veteran, marital or citizenship status, or any other status protected by law.
At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment‑based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.
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