Senior Quality Engineer: Medical Devices, CAPA & Audits

BioTalent; Boston (MA); On-site; USD 110,000 - 140,000; Full time

Job summary

BioTalent is seeking a Senior Quality Engineer for a growing medical device manufacturer in Boston. The role focuses on maintaining and improving a regulated quality system across CAPA, supplier quality, complaints, NCRs, audits, and risk management.

You will collaborate across functions, support ISO 13485 and FDA regulatory requirements, participate in internal and external audits, and drive continuous improvement in product and process quality.

Qualifications

• 5+ years of Quality Engineering experience in a regulated setting.
• Experience with CAPA processes, audits, supplier quality, and quality systems.
• Experience working in FDA- and ISO-regulated environments.

Responsibilities

• Lead and support CAPA investigations and root cause analysis.
• Manage supplier quality activities, audits, and corrective actions.
• Handle customer complaints and nonconforming material investigations.
• Support ISO 13485 compliance and regulatory requirements.
• Participate in internal and external audits.
• Support validation activities and risk management programs.

Skills

Quality Engineering

CAPA

Audits

Supplier Quality

Regulatory Compliance

Education

Bachelor's degree in Engineering or Science

Job description

BioTalent is seeking a Senior Quality Engineer for a growing medical device manufacturer in Boston. The role focuses on maintaining and improving a regulated quality system across CAPA, supplier quality, complaints, NCRs, audits, and risk management.

You will collaborate across functions, support ISO 13485 and FDA regulatory requirements, participate in internal and external audits, and drive continuous improvement in product and process quality.