Job Description

We are looking for an experienced Senior Manager, Quality Assurance - Machining & Production to lead and enhance manufacturing quality processes within our medical device operations. This role plays a pivotal part in ensuring product integrity from design transfer through full-scale production, driving quality excellence across machining, component inspection, and industrialization.

The ideal candidate will have a strategic mindset, a hands-on approach to solving complex quality challenges, and a track record of working collaboratively across manufacturing, supplier quality, and compliance teams. This position will also oversee quality-related integration efforts for acquisitions and ensure consistency in purchasing controls.

Key Responsibilities

• Establish and drive manufacturing quality strategy aligned with operational and business objectives.
• Oversee quality assurance processes throughout the product lifecycle, from design transfer to full-scale production.
• Lead machined part and component inspection, ensuring precision and compliance with quality standards.
• Proactively identify and resolve manufacturing quality issues, conducting thorough root cause analyses and implementing corrective/preventive actions.
• Develop strong relationships with manufacturing teams and suppliers to enhance process control and continuous improvement efforts.
• Conduct internal audits to assess compliance, identify gaps, and drive productivity enhancements.
• Utilize quality data analytics to monitor trends, identify potential risks, and implement meaningful improvements.
• Manage and develop a team of Quality Engineers and Inspectors, fostering a culture of accountability and excellence.
• Lead quality integration efforts for acquisitions, ensuring alignment with existing manufacturing and supplier controls.
• Oversee and optimize quality budgets, balancing cost efficiency with operational excellence.

Qualifications & Experience

• Bachelor's degree in Engineering, Science, or a related field (MBA preferred).
• 10+ years of experience in medical device, pharmaceutical, or regulated manufacturing, covering supplier quality, operations quality, or procurement quality.
• Strong knowledge of FDA regulations, ISO 13485, cGMP, and medical device directives.
• Expertise in root cause analysis, CAPA, statistical sampling, audit techniques, and supplier qualification.
• Ability to influence stakeholders at all levels, including senior leadership, through strong communication and persuasion skills.
• Proven ability to lead and develop high-performing quality teams.
• Skilled in writing and refining procedures, policies, and quality documentation.
• Strong budgeting and resource management experience.

Why Join Us?

• Be part of an innovative company shaping the future of medical device manufacturing.
• Lead impactful quality initiatives that directly improve patient safety and product reliability.
• Competitive compensation, benefits, and professional growth opportunities in a collaborative, high-performance environment.

If you have a passion for quality excellence in machining and production, we encourage you to apply and make a lasting impact in the medical device industry!

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