Senior Quality Engineer (12‑month contract)

About the role

The Senior Quality Engineer will apply quality‑engineering tools and practices to develop and transfer products and processes into commercial operations. The role also focuses on risk management, problem solving and continuous improvement to ensure product and process quality aligns with the company’s business vision.

Key responsibilities

• Represent the Quality function on projects, especially metal‑forming processes.
• Support quality and validation activities for process improvements, product transfers and new product introductions.
• Ensure compliance with equipment, process and systems validation regulations.
• Assess measurement tools, destructive and non‑destructive tests, and conduct measurement system analysis.
• Perform Installation, Operational and Performance Qualification (IQ, OQ, PQ) and test‑method validations.
• Develop and review risk documentation as part of the validation process.
• Partner with cross‑functional teams to apply design controls, manage risk and investigate design failures.
• Investigate, document, review and approve non‑conformances and CAPAs, escalating quality issues when needed.
• Support root‑cause analysis and provide timely reporting on project activities.
• Ensure all work complies with GMP, ISO and relevant quality‑system requirements, as well as health, safety and environmental standards.

Required profile

• BSc in Engineering or Science with at least 3 years of experience in medium‑to‑high volume manufacturing.
• Minimum 2 years in a regulated environment (FDA/ISO).
• Experience with both FDA and European medical‑device regulations (21 CFR 820, 21 CFR 11) is preferred.
• Strong knowledge of GMP, ISO and validation regulations.
• Technical training such as Six Sigma Black Belt or Statistical Engineering is desirable.

Required skills

• Quality Engineering tools and methodologies
• Validation (IQ/OQ/PQ) and test‑method validation
• Risk Management and design‑control application
• Measurement System Analysis, SPC, DOE, Reliability testing
• Statistical analysis and Six Sigma (Black Belt) techniques
• Lean manufacturing principles
• Root‑cause analysis (CAPA)
• Regulatory knowledge: 21 CFR 820, 21 CFR 11, GMP, ISO