MedTech QMS Lead: Build & Scale Global Quality Systems

Agile Search Inc.; Billerica (MA); On-site; USD 120,000 - 170,000; Full time

Job summary

Agile Search is seeking a Senior Quality Systems Engineer for a commercial-stage medical device company, based on-site in Billerica, MA. You will own the QMS end-to-end, including ISO 13485, FDA QMSR, risk management, supplier qualification, post-market surveillance, and MDR reporting, helping scale the organization for global distribution.

5+ years of deep medical device quality system experience and proficiency in 21 CFR 820, ISO 13485, and ISO 14971 are required; IEC 62304/60601-1, 510(k) or

Qualifications

• 5+ years of deep experience with medical device quality systems.
• Proficiency in 21 CFR 820, ISO 13485, and ISO 14971.
• Experience with MDR reporting and regulatory submissions is a plus.
• IEC 62304 and 60601-1 expertise.
• 510(k) or CE technical file experience.
• CQE, CMDA, or lead auditor certification is a plus.

Responsibilities

• Own QMS end-to-end, perform gap analysis for growth and lead implementations.
• Lead meetings, risk management and provide recommendations to drive quality improvements.
• Oversee internal audits and CAPA through root cause investigations.
• Develop quality metrics and apply statistical methods to inform risk-based decisions.
• Own supplier qualification and audits, including post-market surveillance.
• Ensure MDR reporting and maintain continuous improvement of the quality culture.

Skills

QMS ownership

Risk management

Internal audits

CAPA

Statistical methods

Supplier qualification

Regulatory compliance

Quality metrics

Voice of quality

Tools

Quality management software

QMS tools

Job description

Agile Search is seeking a Senior Quality Systems Engineer for a commercial-stage medical device company, based on-site in Billerica, MA. You will own the QMS end-to-end, including ISO 13485, FDA QMSR, risk management, supplier qualification, post-market surveillance, and MDR reporting, helping scale the organization for global distribution.

5+ years of deep medical device quality system experience and proficiency in 21 CFR 820, ISO 13485, and ISO 14971 are required; IEC 62304/60601-1, 510(k) or