Sr Manufacturing Operations QA Manager - Boulder
About The Position
At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working 5 days a week onsite as part of our commitment to direct labor engagement, ensure operational excellence, fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This is an onsite leadership role in Boulder, CO. The Boulder facility is a cornerstone of Medtronic’s Surgical Innovations business, manufacturing more than 30 diverse products. These include advanced energy surgical devices, electrosurgical instruments & accessories, ablation products and components for minimally invasive procedures. Boulder operates 24/7 across three shifts with a highly skilled team of ~800 employees. The Sr. Manufacturing Operations QA Manager is the most senior Quality Assurance leader for the Boulder manufacturing site, responsible for all QA activities supporting site operations and serving as the primary ISO 13485 liaison with BSI. This role drives product quality, regulatory compliance, and operational excellence while reinforcing a patient‑first culture. The leader establishes and executes site quality strategies aligned with Quality and GOSC objectives, influences cross‑functional leadership, and ensures compliance with internal policies and external regulatory standards. The role also oversees audit and inspection readiness, manages regulatory interactions, addresses audit findings, and promotes the sharing of best practices across the organization.
Requirements
- Bachelor’s degree required.
- Minimum of 7 years of relevant Manufacturing Quality / Engineering experience with 5+ years of managerial experience, or an advanced degree with a minimum of 5 years of relevant Manufacturing Quality / Engineering experience with 5+ years of managerial experience.
- Possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Nice To Haves
- Degree in Engineering, Operations or Technical Sciences.
- Medical Device Manufacturing experience within a cleanroom environment.
- DMAIC Lean / Six Sigma Certification and demonstrated experience leading DMAIC Projects.
- Demonstrated experience leading Kaizen Events and multiple Quality-related functions.
- Strong leadership, change management, and transformation skills.
- Excellent communication, interpersonal, and talent management skills.
- Experience leading large-scale change and driving continuous improvement.
Responsibilities
- Lead the manufacturing site in achieving excellence in product quality, regulatory compliance, and operational performance while fostering a culture that prioritizes patients and embeds quality in all aspects of operations.
- Drive site execution of Quality and Global Operations & Supply Chain (GOSC) strategies, ensuring alignment with enterprise objectives and delivering measurable business results.
- Provide leadership and oversight for site quality programs, systems, processes, and procedures to ensure compliance with internal policies and external regulatory standards, including ISO 13485 and other applicable global requirements.
- Ensure the site maintains continuous audit and inspection readiness; lead audit and inspection preparation, manage regulatory interactions, and oversee the timely resolution of findings.
- Partner cross‑functionally with leaders across Quality, Operating Units, Global Operations & Supply Chain, Regulatory Affairs, R&D, Supplier Quality, and other functions to drive quality performance and strategic initiatives.
- Develop and mentor Managers, Engineers, and quality professionals, building organizational capability through coaching, training, and succession planning.
- Promote a culture of continuous improvement and organizational learning by identifying root causes of quality issues, implementing corrective and preventive actions, and sharing best practices across sites and functions.
- Provide oversight for technical quality assurance and control systems related to materials, manufacturing processes, and product performance, and coordinate with external suppliers and partners to ensure quality and delivery expectations are met.
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
