Senior Quality Engineer

About the role

Argon Medical is seeking a Senior Quality Engineer to lead quality engineering activities across new product development, manufacturing, and service support. The role focuses on design controls, risk management, test method validation, and regulatory compliance for medical devices.

Key responsibilities

• Lead and maintain design control deliverables, including design plans, inputs/outputs, reviews, traceability matrix, DHF updates, and DMR readiness.
• Own ISO 14971 risk management activities: hazard identification, FMEA/dFMEA/pFMEA, risk controls, and risk‑benefit rationale.
• Define, review, and approve verification and validation protocols and reports (usability, biocompatibility, sterilization, packaging, shelf‑life, transportation, software).
• Develop, validate, and transfer test methods (TMV/MSA) and establish statistically sound acceptance criteria.
• Ensure data integrity (ALCOA+) and maintain compliant documentation in eQMS/PLM systems.
• Partner with Manufacturing Engineering on process characterization (IQ/OQ/PQ), CTQ definition, control plans, and inspection methods.
• Approve first‑article inspections, align supplier controls with risk, and lead line readiness for pilot builds and production releases.
• Maintain compliance with 21 CFR 820, ISO 13485, MDSAP, ISO 14971, and relevant IEC/ISO standards; provide quality input for 510(k), PMA, and EU technical file submissions.
• Drive root‑cause analysis (5‑Why, Ishikawa, Fault Tree) and implement effective CAPA.

Required profile

• Senior‑level experience in medical device quality engineering.
• Proven expertise with design control processes and documentation.
• Hands‑on experience applying ISO 14971 risk management and conducting FMEA analyses.
• Knowledge of 21 CFR 820, ISO 13485, MDSAP, and related regulatory standards.
• Experience developing verification & validation plans and executing test method validation (TMV/MSA).
• Strong statistical background for acceptance criteria and DOE when needed.
• Ability to lead design transfer, process readiness, and supplier quality activities.
• Experience preparing regulatory submissions (510(k), PMA, EU Technical File).
• Demonstrated skill in root‑cause analysis and CAPA implementation.

Required skills

• Design & Development Plans, Design Inputs/Outputs, Design Reviews, Traceability Matrix, DHF, DMR.
• ISO 14971 risk management, FMEA, dFMEA, pFMEA.
• Verification & Validation protocols (usability, biocompatibility, sterilization, packaging, shelf‑life, transportation, software).
• Test Method Validation (TMV/MSA), accuracy, precision, repeatability, linearity, bias, gage R&R.
• Statistical analysis: tolerance intervals, confidence levels, sample size determination, DOE.
• ALCOA+ data integrity, eQMS/PLM documentation.
• Process characterization (IQ, OQ, PQ), CTQ, control plans, inspection methods.
• First‑Article Inspection approval, supplier controls, SPC, Poka‑Yoke.
• Regulatory standards: 21 CFR 820, ISO 13485, MDSAP, IEC 60601, ISO 10993, ISO 11135/11137, ISO 11607, IEC 62366, IEC 62304.
• Root‑cause analysis techniques (5‑Why, Ishikawa, Fault Tree) and CAPA.