Operations Quality Manager - Brooklyn Center, MN
About The Position
A career at Medtronic is like no other. We’re committed to and driven by our Mission to alleviate pain, restore health, and extend life for millions of people worldwide! Join a diverse team of innovators who bring their worldview, their unique backgrounds, and their individual life experiences to work every day. It’s no accident – we work hard to cultivate a workforce that reflects our patients and partners. We believe it’s the only way to drive healthcare forward and remain a global leader in medical technology and solutions. The Operations Quality Manager will lead quality operations for Medtronic Electronics Components Center (MECC) in Brooklyn Center, MN, a facility that designs, develops, and manufactures critical components used across multiple Medtronic businesses and therapies. Reporting to the Operations Quality Director, this leader will drive quality excellence across the Components Focus Factory, including Connectors/Molding, Capacitors, TDCO, and Feedthroughs. The role is responsible for ensuring timely nonconformance disposition and closure, partnering with downstream Medtronic sites to investigate and resolve quality issues, and fostering a culture of compliance, accountability, and collaboration. This position will also lead continuous improvement and cost-savings initiatives, reduce quality risk, support operational performance, and develop high-performing teams to ensure the delivery of safe, effective, and high-quality products that meet customer and regulatory requirements. 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, Science or technical field with 5+ years of work experience in Engineering, Quality, and/or experience in a regulated industry OR Advanced Degree in Engineering, Science or technical field with 3+ years of work experience in Engineering, Quality, and/or experience in a regulated industry
Nice To Haves
- Experience managing and improving quality systems in compliance with ISO 13485, FDA regulations, CAPA, nonconformance management, change control, and document control requirements.
- Experience with quality processes within a manufacturing environment, including process controls, inspection methods, validation activities, statistical analysis, and quality metrics management.
- Expertise with CAPA to investigate nonconformances and implement effective corrective actions.
- Experience leading internal, external, customer, and regulatory audits; preparing audit responses; addressing findings; and ensuring ongoing compliance with quality and regulatory standards.
- Proficiency in applying Lean, Six Sigma, and continuous improvement tools to reduce quality risk, improve process capability, drive cost savings, establish standard work, and improve operational performance.
- 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
- Provide oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
- Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
- Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
- Lead audit and inspection preparation, resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits.
- Prepare reports and/or necessary documentation (ex Corrective and Preventative Actions) and provide to applicable stakeholders, both internal and external.
- Ensure the quality assurance programs and policies are maintained and modified regularly.
- Facilitate uniform standards worldwide and enable best practice sharing, thereby fostering the achievement of company's mission globally.
- Manage and develop engineers, supervisors, and technician personnel within the Quality function.
- Own issues, drive solutions and implement improvements to maintain Quality Metrics for the Components Factory at MECC.
- Take initiative to establish Lean Philosophy within the team to streamline daily business processes.
- Lead quality related problem solving and root cause analysis during manufacturing.
- Create a culture of collaboration and proactive quality management within MECC Operations.
- Drive standard work to establish One Best Way across focus factories.
- Initiate steps to assure the company quality management systems in place are compliant to ISO 13485.
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
Principal
