Senior Quality Engineer

As a Senior Quality Engineer, you will play a key role in supporting the commercialization of a new medical device product, providing operational quality leadership through verification & validation, manufacturing ramp-up, product release, and post-market activities. You’ll ensure compliance with global regulatory standards and help drive the company’s quality culture as production scales up with a contract manufacturing partner.Key ResponsibilitiesEnsure compliance with FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971, MDR, and other applicable regulations and standards.Lead operations quality support for new product introduction, covering Risk Management, Verification & Validation, Process and Equipment Controls, Material Controls, and CAPA.Develop, implement, and maintain process validations (IQ/OQ/PQ), equipment qualifications, and test method validations in partnership with manufacturing partners.Drive CAPA investigations, root cause analysis, and the implementation of effective corrective and preventive actions.Support supplier quality management, including qualification, auditing, and ongoing performance monitoring.Participate in internal and external audits (FDA, Notified Bodies, ISO, MDSAP).Lead efforts in non-conformance investigations, data trending, and quality metrics reporting.Contribute to continuous improvement initiatives to enhance compliance, efficiency, and product quality.Collaborate with cross-functional teams including R&D, Engineering, Regulatory Affairs, and Operations to ensure quality-first decision making.Develop and maintain departmental procedures, work instructions, and specifications.Qualifications & SkillsBachelor’s degree in Engineering, Life Sciences, or a related technical field.5–8 years’ experience in quality engineering within the medical device industry.Strong knowledge of FDA QSR, ISO 13485, and EU MDR requirements.Proven experience in New Product Introduction, Design Controls, Process Validation, Risk Management, CAPA, and Supplier Quality.Proficiency in statistical analysis tools (e.g., Minitab) and quality methodologies such as FMEA, SPC, DOE, and Root Cause Analysis.Strong analytical and problem-solving skills with meticulous attention to detail.Ability to lead cross-functional projects and influence decision-making.For a confidential conversation about the role please apply for the role or contact Owen Clancy at oclancy@sterlingengineeringeu.com By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose.