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.
Senior Manager
Worcester
Permanent
USD120000 - USD170000
Technical Operations
PR/534721_1741976345
Senior Manager
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!
FAQs
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