Quality Engineer – Supplier & Manufacturing

Job Title: Quality Engineer – Supplier & Manufacturing

Location: Marlborough, MA (Onsite)

Overview:

Seeking a Quality Engineer with combined experience in supplier quality and manufacturing quality within the medical device industry. The role will support supplier qualification, manufacturing process controls, and regulatory compliance to ensure product quality and continuous improvement in a regulated environment.

Required Experience:

• Bachelor’s degree in Engineering or related field
• 3+ years of quality engineering experience in medical device industry
• Strong experience in Supplier Quality Management (supplier audits, qualification, performance monitoring)
• Hands‑on experience with Manufacturing Quality support in a regulated environment
• Experience with CAPA, NCR, SCAR, Root Cause Analysis (RCA)
• Knowledge of FDA 21 CFR Part 820 and ISO 13485
• Experience with risk management (ISO 14971)
• Familiarity with process validation (IQ/OQ/PQ) and statistical tools

Key Responsibilities:

• Manage supplier qualification, audits, and performance monitoring activities
• Support manufacturing operations with quality oversight and issue resolution
• Lead investigations, CAPA, SCAR, and nonconformance activities
• Ensure compliance with FDA and ISO regulatory requirements
• Participate in risk assessments and continuous improvement initiatives
• Support internal and external audits and regulatory inspections