Sr Manufacturing Operations QA Manager - BoulderCobioscience • Boulder, Colorado, United States
Sr Manufacturing Operations QA Manager - Boulder
Cobioscience
- Boulder, Colorado, United States
- Boulder, Colorado, United States
Über
A Day in the Life 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. This onsite leadership role drives product quality, regulatory compliance, and operational excellence, overseeing ISO 13485 liaison, audit and inspection readiness, regulatory interactions, and continuous improvement.
Key Responsibilities
Lead the manufacturing site in achieving excellence in product quality, regulatory compliance, and operational performance while fostering a patient‑first culture.
Drive site execution of Quality and Global Operations & Supply Chain 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.
Ensure continuous audit and inspection readiness; lead audit and inspection preparation, manage regulatory interactions, and oversee 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, coordinating with external suppliers and partners to ensure quality and delivery expectations are met.
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 and 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.
Benefits & Compensation Salary ranges for U.S. (excluding Puerto Rico) locations: $144,800.00 - $217,200.00. This position is eligible for a short‑term incentive called the Medtronic Incentive Plan (MIP). Base pay is based on numerous factors and may vary by job‑related knowledge, skills, experience, etc.
Benefits for regular employees (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
Simple Steps (global well‑being program)
Additional benefits for 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)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Temporary employees receive paid sick time as required under applicable state law and the Employee Stock Purchase Plan.
Equal Employment Opportunity 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 law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
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Sprachkenntnisse
- English
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