Senior Medical Device QMS Engineer — Quality & Compliance

Regulatory Jobs; Billerica (MA); On-site; USD 93,000 - 160,000; Full time

Job summary

Access Vascular is seeking a Quality Engineer to oversee the QMS, ensuring FDA 21 CFR Part 820 and ISO 13485 compliance while guiding a small, hands-on team. You will drive risk-based quality improvements across operations and supplier quality.

The role emphasizes CAPA investigations, document control, audits, and data-driven metrics to support product development, manufacturing, and post-market activities in a dynamic medical device environment.

Qualifications

• Minimum of 5 years’ quality systems experience with a medical device manufacturer.
• Proven track record implementing FDA 21 CFR Part 820 and ISO 13485-compliant QMS.
• Experience owning a QMS end-to-end including CAPA, document control, complaints, internal audits, and supplier quality.
• Strong technical writing and data analysis skills for validation and process capability.

Responsibilities

• Help maintain and continuously improve our QMSR and ISO 13485-compliant QMS.
• Support SOPs, work instructions, forms, test protocols, and controlled documents.
• Participate in internal audits and support external audits (FDA, supplier).
• Lead or support CAPA investigations with root-cause analysis and closure.
• Support supplier qualification, evaluation, and monitoring; conduct supplier audits.
• Assist with post-market surveillance, MDR reporting, and trend analysis.

Skills

QMS management

CAPA investigations

Document control

Internal audits

Supplier quality

FDA 21 CFR Part 820

ISO 13485

Quality writing

Data analysis

Process validation

Education

Bachelor's degree in Engineering or Life Sciences

Tools

CAPA tracking tools

Document control systems

Job description

Access Vascular is seeking a Quality Engineer to oversee the QMS, ensuring FDA 21 CFR Part 820 and ISO 13485 compliance while guiding a small, hands-on team. You will drive risk-based quality improvements across operations and supplier quality.

The role emphasizes CAPA investigations, document control, audits, and data-driven metrics to support product development, manufacturing, and post-market activities in a dynamic medical device environment.