Vacancy Description
Job Title: Quality EngineerJob Description
The Quality Engineer supports the mission of delivering high‑performance medical wire and components by driving quality excellence across CAPA processes, GD&T inspection, and vendor product quality assurance. This role works closely with cross‑functional teams to ensure compliance with regulatory standards and customer expectations, while maintaining robust quality systems and documentation.
Responsibilities
+ Lead and support investigations for non-conformances and customer issues, performing thorough root cause analysis using tools such as 5 Whys, fishbone diagrams, and FMEA.
+ Develop and implement effective Corrective and Preventive Action (CAPA) plans that address identified root causes and prevent recurrence.
+ Monitor CAPA effectiveness, track progress, and ensure timely closure of all actions.
+ Maintain complete and accurate CAPA documentation in accordance with ISO standards, FDA Quality Syst...
The Quality Engineer supports the mission of delivering high‑performance medical wire and components by driving quality excellence across CAPA processes, GD&T inspection, and vendor product quality assurance. This role works closely with cross‑functional teams to ensure compliance with regulatory standards and customer expectations, while maintaining robust quality systems and documentation.
Responsibilities
+ Lead and support investigations for non-conformances and customer issues, performing thorough root cause analysis using tools such as 5 Whys, fishbone diagrams, and FMEA.
+ Develop and implement effective Corrective and Preventive Action (CAPA) plans that address identified root causes and prevent recurrence.
+ Monitor CAPA effectiveness, track progress, and ensure timely closure of all actions.
+ Maintain complete and accurate CAPA documentation in accordance with ISO standards, FDA Quality Syst...
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