Senior Quality Engineer

Key Responsibilities

• Production & Operations Quality - Serve as the quality engineering owner for assigned microfabrication lines, providing floor-level technical support, dispositioning quality issues, and defining the path to resolution.
• Partner with Process Engineering and Equipment Engineering to contain and resolve manufacturing line issues, with a focus on maintaining production continuity.
• Create and maintain compliant medical device files and production records for production builds.
• Drive incoming, in-process, and final acceptance against documented specifications.
• Process & Equipment Validation - Define quality requirements, review and approve, equipment qualification (IQ/OQ) and process validation (MVP, OQ/PQ) for microfabrication and device-assembly processes and equipment, executed in partnership with Equipment Engineering and Process Engineering.
• Lead process risk analysis per ISO 14971, translating risk into the master validation plan (MVP), the validation activities required, and the process control plan (including testing strategy).
• Define and review test-method validation (TMV), including measurement-system analysis and gage R&R.
• Support facilities qualification (IQ/OQ) in collaboration with the Equipment and Facilities Engineering teams.
• Nonconformance, CAPA & Material Review - Lead the nonconformance (NCMR) and Material Review Board (MRB) process — investigation, disposition, and trending — with structured root-cause analysis.
• Lead corrective and preventive actions (CAPA): root-cause analysis, corrective action, effectiveness verification, and timely closure.
• Support supplier corrective action (SCAR) for material- and process-related nonconformances.
• Change Control - Manage the quality aspects of process and engineering change control, documenting technical quality rationale and aligning stakeholders across Process Engineering, Equipment Engineering, R&D–Microfabrication, and Regulatory.
• Perform change impact and risk assessment, identifying and driving follow-on actions such as requalification or revalidation, including changes to process flows and recipes.
• Quality Management System & Continuous Improvement - Assess, mature, and continuously improve site quality processes in line with Precision’s quality management system and FDA QMSR (21 CFR Part 820).
• Own and advance the site validation program for production equipment, processes, and software (including Computer System Validation per GAMP 5 / 21 CFR Part 11).
• Author QMS documents such as SOPs, work instructions, and forms/templates.
• Design Transfer & New Product Introduction - Partner with R&D–Microfabrication and Process Engineering on design transfer and production release for new and transferring programs, including wafer-level test and inspection and quality planning for new product introduction (NPI).
• Contribute to design risk management (ISO 14971, design FMEA) for transferring programs.

Skills, Knowledge and Expertise

• Education + experience: BS in Engineering (Mechanical, Biomedical, Materials, Chemical, Industrial, or related) + 5–10 years of quality engineering experience in regulated or high-reliability manufacturing; or MS in Engineering + 3–8 years of relevant experience.
• Hands-on experience in a microfabrication, semiconductor fab, or comparable cleanroom manufacturing environment.
• Demonstrated technical depth, including:
• Equipment and process qualification and validation (IQ/OQ/PQ or equivalent), authoring and execution.
• Process and engineering change control, including change impact and risk assessment driving requalification or revalidation.
• Statistical methods — SPC, sampling plans, process capability (Cpk), gage R&R, and design of experiments (DOE) — sufficient to support validation and partner with process engineering on yield and variation reduction.
• Nonconformance (NCMR/MRB) and CAPA ownership with structured root-cause analysis.
• Working knowledge of ISO 13485 and FDA QMSR (21 CFR Part 820), or a regulated-industry quality system (e.g., ISO 9001 or equivalent) with the ability to apply it to medical device.
• Demonstrated ability to build, improve, and author quality processes and SOPs with senior individual-contributor autonomy.
• Excellent interpersonal, written, and verbal communication skills.
• Preferred:
• Direct experience in medical device manufacturing (Class II or Class III) under FDA QSR/QMSR or ISO 13485.
• Class III implantable or active implantable medical device (AIMD) manufacturing experience.
• Working knowledge of front-end MEMS fabrication (photolithography, thin-film deposition, plasma etch) and/or back-end microelectronic device assembly (thermal compression bonding, dispense, laser dicing); contamination control and wafer-level test and inspection.
• Computer System Validation (CSV) experience for production equipment software per GAMP 5 and/or 21 CFR Part 11.
• Experience assessing, maturing, and continuously improving a quality management system and the validation program supporting it.
• Working knowledge of risk management per ISO 14971, including design and process FMEAs.
• Working knowledge of Lean, Six Sigma, or equivalent operational-excellence and structured problem-solving methods.
• Quality-engineering knowledge equivalent to ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA).
• Experience supporting design transfer and new product introduction (NPI) from R&D to production.
• Familiarity with electronic QMS (eQMS) and MES.