Quality Manager, Medical Devices & ISO 13485 Quality Assurance
Overview
Own manufacturing quality operations at scale, leading quality engineers and QC functions to ensure compliant production and continuous improvement. Lead NCR/MRB, CAPA, and supplier quality while partnering with Manufacturing, Engineering, Supply Chain, and Operations. Drive data driven decisions and risk reduction with Lean and Six Sigma methodologies. This role offers hands-on leadership in a regulated environment and opportunities to shape quality culture.
What You'll Do9
- 1Build and own manufacturing quality activities across production operations to ensure on time release and product acceptance.
- 2Oversee in process and final inspection, release activities, NCR/MRB, and timely closure by leading quality engineers and QC teams.
- 3Lead CAPA and corrective action initiatives using data analysis and root cause investigation to reduce defects and variability.
- 4Drive continuous improvement initiatives focused on quality, yield, efficiency, and risk reduction using Lean, Six Sigma and other methodologies.
- 5Support new product introductions, equipment installations, and process changes through quality planning and risk assessment.
- 6Ensure compliance with FDA QMSR, ISO 13485, and applicable regulatory requirements and support audits including FDA and notified body inspections.
- 7Partner with cross functional teams to resolve quality issues and implement robust process controls.
- 8Support supplier quality activities related to manufacturing and incoming material performance to ensure supply chain reliability.
- 9Provide leadership with data driven reports on quality performance, risks, trends, and improvement initiatives.
Requirements9
- 1Bachelor's degree in Engineering or related discipline
- 28+ years of progressive quality experience in medical device aerospace defense or IVD manufacturing
- 33+ years of experience managing Quality Engineers and or QC teams
- 4Experience leading Manufacturing Quality activities NCR MRB processes and shop floor quality execution
- 5Strong knowledge of ISO 13485 and risk based quality principles
- 6Strong analytical problem solving leadership and communication skills
- 7Ability to work collaboratively across manufacturing and technical functions
- 8Willingness and ability to travel approximately 5 10 to support vendors customer sites troubleshooting and system testing
- 9Prior medical device manufacturing experience is required
Salary Insight
$150 - $180k per year
Location
Required Skills
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