Quality Systems Manager - Change Control

Medtronic Inc. • Los Angeles, CA

32d • Hybrid

About The Position

In this exciting role as a Quality System Manager - Change Control, you will have responsibility for leading the QMS change control process for the Medtronic Diabetes business. This position is an exciting opportunity to work with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care. This position is expected to be onsite, with the possibility to be at a hybrid capacity position which requires 3 days in the office and 2 days working in a remote capacity.

Requirements

• Requires a Baccalaureate degree
• Minimum of 5 years relevant experience in Quality Management setting in a regulated industry, or advanced degree with a minimum of 3 years prior relevant experience.

Nice To Haves

• 10+ years of work experience in Quality Management setting in a regulated industry
• Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area.
• Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization.
• Capable of effectively managing multiple demands from a variety of sources.
• Strong expertise with managing complex situations, comfortable escalating issues and operating in grey area.
• Excellent written and verbal communication abilities
• Working knowledge in the medical device industry, including working knowledge of 21CFR 820, 806, 803, Part 11, Part 4; ANVISA, TGA, Health Canada, EU, China & Japan regulations; ISO 13485, MDSAP, etc.
• Experience supporting continuous improvement projects
• Strong critical thinking and analytical skills

Responsibilities

• Provides 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.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
• Leads the QMS change control process, including QMS document changes and product related changes in the QMS software.
• Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.
• Co-ordinates legal requests in support of government investigations or litigations.
• Ensures the quality assurance programs and policies are maintained and modified regularly.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• 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, and 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Number of Employees: 5,001-10,000 employees