Senior Quality Engineer

Responsibilities

• Provide quality engineering support throughout the product development lifecycle by applying ISO 13485, ISO 14971, and FDA design control principles to ensure compliance.
• Serve as a Subject Matter Expert and own Risk Management (Hazards Analysis and FMEAs) across the assigned product families, primarily complex electro‑mechanical devices.
• Support design verification, validation, and reliability testing.
• Participate in supplier qualifications.
• Identify and implement effective process control systems to support the development, qualification, and on‑going manufacturing of products to meet or exceed internal and external requirements, supporting design transfer activities.
• Apply sound, systematic problem‑solving methodologies in identifying, prioritising, communicating, and resolving quality issues.
• Support audits, CAPA investigations, and continuous improvement initiatives.

• Detailed knowledge of FDA 21
  
  CFR 820, GMP, MDD, EU‑MDR, ISO 13485 and ISO 14971.
• Engineering and technical experience and demonstrated use of quality tools/methodologies.
• Experience with planning and executing design verification testing, test method development and test method validation (hands‑on execution experience preferred).
• Ability to author technical reports, business correspondence and SOPs.
• Experience with planning and executing process validations (TMV, IQ/OQ/PQ) including authoring Master Validation Plans and Reports.

• Minimum bachelor’s degree in engineering or science and 5+ years of relevant work experience OR master’s degree with 3+ years of work experience in quality and/or engineering.
• Detailed knowledge of FDA 21
  
  CFR 820, ISO 13485, ISO 14971 and EU‑MDR to ensure full compliance with design control principles and global medical device regulations.
• Serving as a subject‑matter expert for risk management (hazards analysis, FMEAs), leading design verification and validation testing, and executing process validations (TMV, IQ/OQ/PQ).
• Working knowledge of IEC 62304 and IEC 60601‑1.
• Ability to drive process‑improvement activities.
• ASQ certification in quality or reliability.
• Ability to multi‑task, prioritise, meet/exceed deadlines, and hold themselves and others accountable.

Mid‑Senior level

Contract

Quality Assurance

Pharmaceutical Manufacturing