QC Operations Manager – Medical Devices & NPI
Cretex Medical Component and Device Technologies
14 days+
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Job summary
Cretex Medical Component and Device Technologies is seeking a Quality Control Manager to lead inspection and quality control functions. This role involves partnering with teams to ensure compliant product realization and drive operational excellence. Responsibilities include team leadership, quality strategy development, and stakeholder communication. Requires a Bachelor's degree in engineering, 5+ years in Quality Control, and strong knowledge of FDA and ISO standards. Competitive salary range of USD $100,900.00 - USD $151,300.00/year.
Qualifications
- 5+ years in Quality Control or Manufacturing Quality.
- 5+ years of Leadership experience.
- Experience in high-mix manufacturing environment.
Responsibilities
- Lead, coach, and develop Inspection and Quality Control teams.
- Own the end-to-end inspection and quality control lifecycle.
- Drive initiatives to improve first-time-right quality and reduce cycle time inspection.
- Partner with cross-functional teams to align inspection strategy.
Skills
Strong FDA 21 CFR 820 knowledge
ISO 13485 knowledge
Lean/Six Sigma experience
Strong data and problem-solving skills
Education
Bachelor’s degree in engineering or related field
Job description
Cretex Medical Component and Device Technologies is seeking a Quality Control Manager to lead inspection and quality control functions. This role involves partnering with teams to ensure compliant product realization and drive operational excellence. Responsibilities include team leadership, quality strategy development, and stakeholder communication. Requires a Bachelor's degree in engineering, 5+ years in Quality Control, and strong knowledge of FDA and ISO standards. Competitive salary range of USD $100,900.00 - USD $151,300.00/year.
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