Sr Manufacturing Operations QA Manager - Boulder

We anticipate the application window for this opening will close on 30 Jun 2026.

At Medtronic you can begin a life‑long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

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.

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.

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.

• 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…