Quality Engineering Manager - Brooklyn Park
About The Position
The Quality Engineering Manager at our Brooklyn Park, MN facility is responsible for driving quality performance, maintaining compliance with internal and external requirements, and providing day-to-day leadership for quality operations of perfusion systems manufacturing. Working closely with site leadership and cross-functional partners across multiple functions, this leader will help ensure products are manufactured in a state of control and meet Medtronic’s high standards for safety, quality, compliance, and reliability. 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 a minimum of 5 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
Requirements
- Bachelor’s Degree in Engineering or scientific related field with 5+ years of work experience in Quality and/or experience in a regulated industry OR Advanced Degree with 3+ years of work experience in Quality and/or experience in a regulated industry
- Possess unrestricted U.S. work authorization at the time of hire and for the duration of employment (for roles below Principal level).
Nice To Haves
- Working knowledge of FDA Quality System Regulation, ISO 13485, and applicable global regulatory requirements
- Experience with nonconforming material processes, CAPA systems, deviation management, and root cause investigations
- Demonstrated use of quality metrics and KPIs to drive operational performance and compliance improvements
- Lean, Six Sigma, or similar continuous improvement experience
- 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.
Responsibilities
- Lead, manage, coach, and develop a team of Quality Engineers supporting manufacturing operations at the Brooklyn Park facility.
- Provide day-to-day oversight of quality engineering activities supporting perfusion systems manufacturing for Medtronic’s Cardio Vascular Surgery business.
- Ensure quality operations are conducted in compliance with Medtronic policies, internal procedures, quality system requirements, and applicable external regulatory requirements.
- Monitor, analyze, and drive improvement of site quality key performance indicators, including product quality, process quality, nonconforming product, CAPA, audit readiness, and other operational quality metrics.
- Partner with Operations, Manufacturing Engineering, Supplier Quality, Sterilization Assurance, and site leadership to identify, prioritize, and resolve quality and compliance issues.
- Develop, evaluate, implement, and maintain technical quality assurance and control systems, reliability systems, and standards pertaining to materials, techniques, manufacturing processes, and company products.
- Lead or support investigations, root cause analysis, corrective and preventive actions, and risk-based decision-making for quality issues impacting manufacturing operations.
- Provide quality oversight for process changes, validations, manufacturing controls, quality planning, and continuous improvement activities.
- Ensure effective documentation practices and maintenance of quality records throughout applicable product and process lifecycle phases.
- Establish operational plans and implement policies, strategies, and priorities for the Quality Engineering function.
- Organize and coordinate activities with internal partners, outside suppliers, and consultants, as needed, to ensure timely delivery of quality-related commitments.
- Communicate with internal and external customers, suppliers, and vendors regarding ongoing quality operations, quality performance, and issue resolution.
- Drive continuous improvement and consistency in quality deliverables, processes, and team performance.
- Support audit and inspection readiness activities, including preparation, execution, response, and remediation.
- Escalate quality risks, compliance concerns, and product performance issues appropriately to site and business leadership.
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
Manager
