Quality Engineer

Job Summary:

Under the supervision of the Regulatory and Quality Systems Manager, the Quality Engineer is a development-oriented role intended to build capability across both new product development/design transfer and site quality/sustaining production. The position will partner with Engineering, Operations, Supplier Quality, Quality Systems, and other cross-functional groups to support compliant product launch, production readiness, and ongoing manufacturing quality. Primary assignments may emphasize the NPD/design transfer path or the site quality path based on business needs, individual skill set, and capacity requirements.

Essential duties and responsibilities:

• Ensure assigned quality engineering activities comply with ISO 13485, applicable FDA/QMS requirements, customer requirements, and MPE quality system procedures.
• Review drawings, specifications, BOMs, work instructions, test/inspection criteria, labeling, packaging, and other quality records for manufacturability, control, and objective evidence needs.
• Support transfer and production readiness activities, including FMEA, CTQs, control plans, inspection strategy, PPAP, qualification/validation planning, and production readiness reviews.
• Apply statistical tools to sampling plans, measurement systems (GR&R), process capability, test planning, and data review as appropriate.
• Develop and maintain acceptance criteria, inspection/test methods, and production release evidence requirements for receiving, in-process, final inspection, and finished product release.
• Plan, execute, and document IQ/OQ/PQ, process validation, TMV, or other qualifications as assigned.
• Provide site quality support for production, including DHR/product release review, containment, rework/reinspection planning, NCR/MRB disposition support, and quality-related line issue resolution.
• Lead or support investigations for nonconformances, complaints/RMAs, deviations, audit findings, and CAPAs with emphasis on containment, root cause, corrective action, and effectiveness verification.
• Analyze manufacturing, inspection, complaint, NCR, CAPA, and qualification data to identify trends and support risk-based quality improvements.
• Support handoff between NPD, sustaining production, and site quality teams, including early-life production monitoring after launch.
• Perform other duties to support the QMS as assigned.

Education

• Bachelor’s degree in engineering, Quality, Science, or related technical discipline, or equivalent combination of education and experience.

Experience and/or Training

• 2-5 years of experience in manufacturing engineering or quality assurance.
• Working knowledge of quality engineering methods such as risk management, FMEA, control plans, NCR/CAPA, root cause analysis, sampling plans, GR&R, capability, PPAP/FAI, and qualification/validation.
• Familiar with FDA regulations and ISO 13485.
• Ability to prepare clear technical justifications, investigation summaries, qualification/test reports, and quality records suitable for audit or customer review.
• Familiar with change control, document control, ERP/MRP systems, inspection planning, and production floor support.
• Preferred candidates hold a Certified Quality Engineer (CQE), Lean/Six Sigma, or similar quality certification.

Physical and mental demands

• Continuous- Sitting, seeing, hearing, speaking, reading, computer use, comprehension
• Frequent- Critical thinking, problem solving, reasoning, complex information processing
• Occasional- Decision making
• Intermittent- fine motor skills for manipulating tools or equipment, lifting up to 30 lbs., walk and stand for inspections