Sr Manufacturing Operations QA Manager - Boulder

Sr. Manufacturing Operations QA Manager

Join us at Medtronic, where bold ideas and decisive leadership are transforming healthcare. If you are driven by purpose, thrive on solving complex challenges, and excel in leading diverse teams, we invite you to join us in creating life-changing medical technology.

At Medtronic, we must work with a sense of purpose and ownership, knowing there is a human life on the other side of every decision. This role demands ownership, accountability, and an unwavering focus on execution. Reporting to the Manufacturing Operations QA Director – Colorado Campus, the Sr. Manufacturing Operations QA Manager will lead quality operations at our Boulder, CO facility, a key hub for Surgical Innovations (SI) within the Medical Surgical portfolio.

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.

Key responsibilities may include the following and other duties may be assigned:

• 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.

Must have: minimum 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.

Nice to have

• 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.

Join us in our mission to alleviate pain, restore health, and extend life—where your unique background and perspective are valued.

Medtronic offers a competitive salary and flexible benefits package. A commitment to our employees lives at the core of our values. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD): $144,800.00 - $217,200.00. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico. Base pay is based on numerous factors and may vary by job-related knowledge, skills, experience, etc. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Learn more about our business, mission, and our commitment to diversity here.