Manufacturing Quality Engineer

Key Responsibilities

• Ensure compliance with FDA 21 CFR 820 and ISO 13485 during manufacturing and inspection processes.
• Lead and support process validation activities (IQ/OQ/PQ), test method validations (TMV), and equipment qualifications.
• Review and approve Device History Records (DHRs) for completeness and compliance prior to product release; identify and resolve discrepancies.
• Maintain DHR templates to ensure accurate documentation of manufacturing activities.
• Manage manufacturing nonconformance records and CAPAs; lead root cause investigations and implement effective corrective/preventive actions.
• Develop and maintain manufacturing quality documentation including inspection procedures and work instructions.
• Conduct line audits and floor inspections to verify adherence to Good Manufacturing Practices (GMPs) and internal quality standards.
• Participate in internal and external audits and support timely responses to observations/findings.
• Maintain and update PFMEAs and participate in risk assessments related to process changes and product quality.
• Collaborate with cross-functional teams including Engineering, Operations, and Regulatory Affairs during NPI and design transfer.
• Monitor process performance through data analysis and statistical tools to support continuous improvement initiatives.
• Responsible for incoming inspections.
• Support supplier quality activities and product release processes.

Required Qualifications

• Bachelor’s degree in Engineering (Industrial, Biomedical, or related field).
• Minimum 2 years of quality engineering experience in a regulated medical device manufacturing environment.
• Proficient in ISO 13485, 21 CFR 820, and design control requirements.
• Hands-on experience with process validation (IQ/OQ/PQ), CAPA, FMEA, and DHR review.
• Familiarity with risk management per ISO 14971.
• Strong analytical, documentation, and problem-solving skills.

Preferred Qualifications

• Experience with radiological or electromechanical medical devices.
• Familiar with engineering drawings and GD&T.