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.
An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
The above list reflects the general details necessary to describe the principle and essential functions of the position and shall not be construed as the only duties that may be assigned for the position.
Minimum/Preferred Qualifications:
Education
- Bachelor’s degree in Engineering, Quality, Science, or related technical discipline, or equivalent combination of education and experience.
Experience and/or Training
- 0-3 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
The mental and physical requirements described here are representative of those that must be met by an individual to successfully perform the essential functions of this position.