Senior Quality Engineer

Responsibilities

Sustaining Quality

• Serve as the Quality Engineering partner for sustaining engineering and post-market product activities, ensuring continued compliance with applicable quality and regulatory requirements.
• Provide Quality oversight for product, component, manufacturing, supplier, and design changes, including assessment of verification and validation requirements.
• Support nonconformance, complaint investigation and CAPA activities, including root cause analysis, risk assessment, corrective actions, and effectiveness verification.
• Partner with Engineering and Operations to investigate product and manufacturing issues and implement sustainable corrective and preventive solutions.
• Maintain and update Risk Management Files in accordance with ISO 14971, incorporating post-market information, product changes, complaints, and identified risks.
• Analyze quality and product performance metrics to identify trends and drive systemic quality and reliability improvements.
• Provide technical Quality expertise for electrical and electromechanical product issues and changes.

Supplier Quality

• Responsible for supplier quality programs including supplier evaluation, selection, qualification, re-qualification and maintenance of the Approved Supplier List (ASL).
• Plan and perform onsite and remote supplier audits to assess compliance with ISO 13485, regulatory standards, and internal requirements.
• Establish and maintain supplier quality agreements.
• Monitor supplier quality performance through scorecards and periodic quality reviews, including Supplier Corrective Action Requests (SCARs) and drive them to closure.
• Define incoming inspection requirements, sampling plans, and first article inspection for purchased components.
• Lead disposition of supplier-related nonconformances through MRB.
• Review supplier process capability and validation evidence for critical-to-quality characteristics during supplier qualification and change approval.
• Lead supplier quality improvement initiatives.

Manufacturing & Process Quality Oversight

• Partner with Manufacturing Engineering on process characterization, process capability (Cpk/Ppk), SPC, pFMEA, and process and equipment validation (IQ/OQ/PQ).
• Review and approve protocols and reports ensuring acceptance criteria are risk-based and statistically justified.
• Develop and execute verification and validation plans, protocols, and reports for sustaining activities, including test method validation for inspection and test methods, as applicable.

Quality System & Leadership

• Support continuous improvement of Quality System procedures, Standard Operating Procedures, and Work Instructions.
• Mentor junior engineers and Quality team members, and promote strong Quality Engineering practices across cross-functional teams.
• Perform other responsibilities as assigned.

Qualifications

• 5+ years of Quality Engineering or Sustaining Engineering experience within the medical device industry, preferably supporting commercial electromechanical products.
• Demonstrated experience with post-market and sustaining quality activities, including nonconformances, CAPAs, change control, root cause investigations, and verification and validation.
• Working knowledge of ISO 13485, FDA Quality System requirements, ISO 14971, and IEC 60601-1.
• Experience applying risk management principles throughout the commercial product lifecycle.
• Strong technical problem-solving and root cause analysis skills.
• Bachelor’s degree in Engineering, Science, or a related technical discipline; Master’s degree is a plus.
• Ability to work effectively across Engineering, Manufacturing, Operations, Supplier Quality, and other cross-functional teams.
• Strong organizational skills with the ability to manage multiple priorities and consistently complete work on schedule.
• Excellent written and verbal communication skills.