Senior Quality Assurance Engineer

Our client, a leading medical device company, has engaged GForce Life Sciences to provide a Senior Quality Assurance Engineer. This role provides quality engineering support across quality assurance, control, and preventative activities within operations and other business functions, with a focus on EU-MDR initiatives for a portfolio of products. Responsibilities Provide quality engineering support for EU-MDR initiatives across a product portfolio. Develop and implement methods and procedures for process control, process improvement, testing, and inspection to support product compliance and performance. Support First Article Inspection (FAI) strategy development, execution, and approvals. Support Production Part Approval Process (PPAP) activities. Support change control and perform change impact assessments. Support SOP and risk documentation updates and reviews. Support equipment and process validations. Advocate and lead initiatives/projects to enhance quality performance and support compliance to regulations and standards. Mandatory Requirements Bachelor’s degree in an engineering field (e.g., Biomedical Engineering, Mechanical Engineering, or related field). 4+ years of industry experience. Experience supporting EU-MDR programs/initiatives. Excellent English (oral and written). Nice to Have Firm understanding of medical device concepts. Familiarity with ISO 13485 and EU Regulations; GDP/GMP concepts. Knowledge of risk-based and statistical concepts. #J-18808-Ljbffr GForce Life Sciences