Senior Quality Engineer

Job TitleLead validation, qualification, and risk management activities across products and processesJob DescriptionLead validation, qualification, and risk management activities across products and processes. Support New Product Introduction (NPI) with strong quality oversight and compliance guidance. Develop and maintain QMS processes, including procedures, templates, and documentation. Partner with engineering, manufacturing, supply chain, and R&D to drive quality initiatives. Oversee verification & validation (V&V) lifecycle for new and existing products. Investigate nonconformances, deviations, and complaints using structured RCA methodologies. Drive CAPA effectiveness using tools such as 5 Whys, Fishbone, and FMEA. Ensure all product and process changes are risk-assessed and compliant with standards. Contribute to internal audit programs and support audit readiness. Train and coach teams on quality systems, validation, and best practices. Promote a culture of continuous improvement and risk-based thinkingThe Successful ApplicantBachelor's degree in Engineering or a scientific discipline. 5+ years of Quality Assurance experience in a regulated industry. Strong knowledge of ISO 13485 and ISO 9001 standards. Hands-on experience with validation methodologies and V&V processes. Solid understanding of design and development lifecycle (NPI-focused). Proven track record in CAPA, root cause analysis, and continuous improvement. Experience conducting internal audits (Lead Auditor certification a plus). Strong cross-functional communication and stakeholder management skills. Ability to thrive in a fast-paced, evolving manufacturing environmentWhat's on OfferCompetitive salary ranging from $95000 to $118000 USD annually. Join a brand-new, advanced manufacturing facility with strong investment. Play a key role in shaping quality and validation frameworks. High visibility partnering across engineering, ops, and leadership. Strong benefits package including generous PTO and parental leave. Work within a global organization known for stability and growthContact Kyle Perry Quote job ref JN-072026-7062202Job SummarySector: Engineering & ManufacturingSub Sector: Quality, TechnicalIndustry: Industrial / ManufacturingLocation: AyerContract Type: Permanent