Senior Quality Engineer

Overview In this role you will lead the quality function to maintain and improve the quality system in line with ISO 9001, ISO 13485, MDSAP and FDA/EU requirements. You will drive cross-functional quality initiatives, supplier quality, and product/service improvements using data-driven methods.

The role emphasizes leadership of corrective actions, audits, and continuous improvement projects, delivering measurable quality outcomes. This is an opportunity to shape quality systems in a global healthcare environment and collaborate across departments.

Retribuzione / Benefits corporate bonus Responsabilità Serve as Core Team Member on cross-functional NPD/servDes teams with focus on quality plans and transfer Develop and implement statistically valid sampling plans, DOE, capability studies, SPC and trend analysis Lead process and product corrective actions and problem-solving activities Review current quality system and implement improvements Use data to propose process/product changes to improve quality Lead projects on quality system and product/service improvements Develop analyses and reports on quality system performance Lead supplier audits and corrective actions Lead and support internal and external quality system audits Instruct colleagues in quality principles and statistical techniques Collaborate with other departments on quality issues Supervise Quality Engineers and staff in duties and objectives Maintain product integrity via nonconforming material/process evaluation and disposition Perform other duties as assigned Requisiti fondamentali Minimum 5 years of related Manufacturing/Quality Engineering and/or Quality Systems experience with strong supplier quality experience Experience in an ISO-certified environment; medical device or regulated industry preferred Experience with supplier qualification and audits, SCAR/CAPA, root-cause investigation, risk management, and supplier performance improvement ASQ, QSR or familiarity with QSR/GMP regulations Technical leadership Cross-functional collaboration Coaching and mentoring Quality systems and continuous improvement Data-driven decision making and metrics analysis Statistical techniques (SPC, capability studies, DOE)

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