Senior Quality Engineer

This is a fixed term contract (inc full benefits) that will run until 31st August 2028.

The Senior Engineer, Quality Assurance will establish, improve and maintain the quality system by providing quality engineering support within operations and other business functions.

Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Ensure to deliver high quality products that meet customer needs. Ensure compliance with regulations and standards.

• Work closely with operations and the business functions to ensure quality performance of product and processes
• Collaborate cross-functionally with internal and external teams to resolve quality issues
• Manages internal and supplier-driven Non-Conformances (NCs), ensuring timely investigation and closure
• Owns Corrective and Preventive Actions (CAPAs) through root cause analysis to closure
• Disposition of non-conforming product through MRB, issuing NCs as appropriate
• Initiates and leads in the development and improvement of the manufacturing processes for existing and new products.
• Review and approval of change management activities, challenges change effectiveness and drives strong review.
• Interpret KPI trends, act as necessary, driving a continuous improvement process.
• Support the execution and analysis of manufacturing complaints and product field actions
• Provide QA support during internal and external audits
• Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
• Proficient in risk management practices and concepts and applies knowledge to manufacturing operations and identify opportunities and weaknesses
• Lead and participate in the Lean philosophy – standardization and elimination of waste
• Understanding of Human Error Prevention and the application of those principles to the manufacturing environment.
• Support process/equipment validation, qualification, and Measurement System Analysis (MSA)
• Support with product holds and executing containment Plans
• Manage supplier relationships, including but not limited to, coordinating communications, monitoring performance, managing in house and external nonconformities and ensuring timely delivery of quality materials and services.

• Honours Bachelor’s Degree – United States of America & Ireland & China
• EQF Level 6 or equivalent– EU
• 2+ years’ experience in a Quality or Regulatory Affairs role; prior industry experiences desirable
• Proficient in understanding of Med Device manufacturing processes, ISO 13485, GMP.
• Lean Six Sigma training is a distinct advantage.
• Excellent communication skills and attention to detail.
• Proficient understanding of engineering and quality principles, including Risk Management, CAPA, Audits, and Statistics
• High level knowledge/experience of Risk Based and statistical techniques, in particular process risk, statistical sampling plans, Process Capability, Gauge R&Rs.
• High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.
• Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
• Exhibits strong leadership and mentoring behaviors.
• Strong problem-solving, analytical, and communication skills with high attention to detail
• Builds strong relationships through open communication, respect, and trust
• Team player with a customer/stakeholder-focused approach
• Diplomatic, tactful, and effective at leveraging interpersonal skills
• Embraces change with a continuous improvement mindset.
• Fluent in written and oral English - B2 Level (writing documents, meeting minutes, conference calls, technical…