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 premio 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)
* corporate premio 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)