Senior Quality Systems Specialist
About The Position
Bring your talents to an industry leader in medical technology and healthcare solutions – we’re a market leader and growing every day. You can be proud to part of technologies that are rooted in our long history of mission-driven innovation. You will be empowered to shape your own career. We support your growth with the training, mentorship, and guidance you need to own your future success. Together, we can transform healthcare. In this exciting role as a Sr Quality Systems Specialist- CAPA Specialist supporting the Enterprise Functional CAPA group - you will have responsibility for compliance to the Corrective and Preventive Action (CAPA) processes and Medical Device regulations and requirements, serve as a CAPA subject matter expert; provide guidance to CAPA owners and CAPA Board members to develop CAPA activities and conduct assessment of CAPA documentation. 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 work a minimum of five days per 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
- Requires a Bachelor's degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
- Experience working with non ‐ conformances, corrective and preventive actions
- Experience conducting effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
- Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
- Support CAPA process and several individual records for a specific set of CAPAs that will have high visibility and require increased oversight.
- Experience in medical device, pharmaceutical and/or a comparable regulated environment
- Experience working with non ‐ conformances, corrective and preventive actions
- Strong analytical, process improvement, critical thinking and decision-making skills
- Ability to educate people in the CAPA program
- CAPA documentation systems experience ( e.g. Trackwise , PQM )
- Influence management skills; ability to work constructively across all functions of the organization as well as external customers
- Project management skills
- Experience reviewing technical documentation
- Strong written and verbal communication skills
- Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and Medtronic quality requirements
- 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
- 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.
- Develops, modifies , applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials product .
- Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment .
- Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements .
- Provides Corrective and Preventive CAPA oversite and guidance.
- Develops employee communication and training programs that focus on the elements of a companywide CAPA and compliance program .
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
Senior
