Senior Quality Engineer
OverviewIn this role you will lead the quality function to maintain and improve the quality system in line with ISO ****, ISO *****, 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 / Benefitscorporate premio
ResponsabilitàServe 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 fondamentaliMinimum 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)
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 / Benefitscorporate premio
ResponsabilitàServe 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 fondamentaliMinimum 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)