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. Youll 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 -person exchanges are invaluable to our work. Were 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 is an onsite leadership role in Boulder CO.

The Boulder facility is a cornerstone of Medtronics 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 patientfirst culture. The leader establishes and executes site quality strategies aligned with Quality and GOSC objectives influences crossfunctional 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 crossfunctionally 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

To be considered for this role please ensure the minimum requirements and your permanent address are evident on your resume.

• Bachelors 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 relevantManufacturing Quality / Engineeringexperience 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.

For Baccalaureate degrees earned outside of the United States a degree that satisfies the requirements of 8 C.F.R. 214.2(h)(4)(iii)(A) is required.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

U.S. Work Authorization & Sponsorship

At Medtronic we are committed to fostering an environment where employees can thrive and make a meaningful alignment with our enterprise-wide workforce planning approach U.S. work authorization sponsorship (H-1B TN J etc.) is offered exclusively for Principal-level roles and above where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Join us in our mission to alleviate pain restore health and extend lifewhere 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. We recognize their contributions. 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):$144800.00 - $217200.00

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 insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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.

Further details are available at the link below:

Medtronic benefits and compensation plans

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.

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

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by federal state or local addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.