About the Company
Medtronic is a global leader in medical technology, alleviating pain, restoring health, and extending life for millions of people worldwide. We are committed to innovation, quality, and making a meaningful difference in the lives of patients. Our Boulder facility plays a critical role in developing and manufacturing life-saving medical devices. Join a company where your work truly matters.
Job Description
We are seeking an accomplished and visionary Director of Quality Control to lead our quality assurance and control functions at our state-of-the-art facility in Boulder, CO. This executive-level position is crucial for ensuring the highest standards of product quality and regulatory compliance across all manufacturing processes and products. The successful candidate will be instrumental in shaping our quality strategy, driving continuous improvement initiatives, and fostering a culture of excellence. A comprehensive relocation package is available for the right candidate.
Key Responsibilities
- Develop, implement, and maintain a robust Quality Management System (QMS) compliant with FDA, ISO 13485, and other relevant international regulations.
- Provide strategic leadership and direction for all quality control and assurance activities, ensuring alignment with corporate goals and industry best practices.
- Oversee all aspects of product quality, from raw material inspection through finished product release, including in-process controls, testing, and documentation.
- Lead, mentor, and develop a high-performing team of quality professionals, fostering a culture of accountability, continuous learning, and excellence.
- Drive continuous improvement initiatives through data analysis, root cause investigations, corrective and preventive actions (CAPA), and lean methodologies.
- Act as a primary liaison during regulatory inspections and customer audits, ensuring swift and effective resolution of any findings.
- Collaborate cross-functionally with R&D, Manufacturing, Supply Chain, and Regulatory Affairs to integrate quality throughout the product lifecycle.
- Establish and monitor key quality metrics and performance indicators, reporting regularly to senior leadership.
- Manage the quality budget and resources effectively to achieve departmental and company objectives.
Required Skills
- Proven executive leadership experience in Quality Control/Assurance within the medical device or a highly regulated industry.
- Deep expertise in FDA regulations (21 CFR Part 820), ISO 13485, and other global quality standards.
- Strong understanding and practical application of quality tools and methodologies (e.g., Six Sigma, Lean, SPC, FMEA).
- Exceptional analytical, problem-solving, and decision-making capabilities.
- Demonstrated ability to build, lead, and inspire diverse teams.
- Excellent communication, interpersonal, and presentation skills.
- Bachelor's degree in Engineering, Life Sciences, or a related technical field.
Preferred Qualifications
- Master's degree or Ph.D. in a relevant scientific or engineering discipline.
- ASQ Certifications (e.g., CQE, CQA, CMQ/OE).
- Experience with PLEX or other enterprise-level ERP systems.
- Prior experience managing quality operations across multiple sites or product lines.
Perks & Benefits
- Comprehensive health, dental, and vision insurance plans.
- Generous paid time off and holidays.
- 401(k) retirement plan with company match.
- Executive-level bonus opportunities.
- Stock options and long-term incentives.
- Company-sponsored professional development and training programs.
- On-site fitness centers and wellness programs.
- Comprehensive relocation package to Boulder, CO.
- Collaborative and innovative work environment.
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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