Senior Quality Systems Specialist

Medtronic•Brooklyn Center, MN

14d•Onsite

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives. As a Senior Quality Systems - CAPA Specialist, you will have responsibility for coordinating the Medtronic Energy and Component Center (MECC) Quality CAPA Portfolio. Coordination includes partnering with those team members to define, investigate, execute, and resolve product and quality systems issues to ensure they don’t recur. By supporting the Quality Function, you will provide critical compliance guidance and direction for CAPA impacting battery and component nonconformances, complaints, regulatory reporting, PHO, and FCA. Responsibilities will include additional Quality Management System project work as needed. 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 4 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 with 4+ years of work experience in Quality or regulated industry OR Advanced degree with 2+ years of work experience in Quality or regulated industry

Nice To Haves

Experience working with non-conformances, corrective and preventive actions (CAPA), including conducting effective root cause investigations, CAPA planning, execution, and verification of effectiveness techniques
Support and oversight of CAPA process, including management of high-visibility CAPA records
Ability to educate and influence others within the CAPA program; experience with CAPA documentation systems (e.g., Trackwise)
Experience in medical device, pharmaceutical, and/or other regulated environments
Strong analytical, process improvement, critical thinking, and decision-making skills
Project management skills and experience reviewing technical documentation
Strong written and verbal communication skills
Influence management skills; ability to work constructively across all functions of the organization and with external customers
Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and Medtronic quality requirements
Experience with internal and external audits

Responsibilities

Provide continuous and rigorous assessment of CAPA activities and documentation to assure compliance with Medtronic internal policies in general and specific to CAPA process, FDA regulations, ISO 13485, Medical Device Requirements, and governmental regulations through the review of CAPA records at critical phases.
Participate in CAPA Board activity and perform CAPA Specialist role.
Provide guidance, support and mentorship to CAPA Owners, CAPA Board Members and CAPA Board Chairs regarding the CAPA process, CAPA best practices, CAPA record content, and CAPA software tools.
Track CAPA metrics and report on critical aspects regarding the health of the CAPA process.
Support the development and implementation of Quality System CAPA procedures, CAPA software, and CAPA training programs.
Support internal and external audits and inspections for CAPA records and processes.
Participate in audits and inspections in multiple audit support roles in the front and back room.
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 ensure compliance.
Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.
Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
Prepares reports and/or necessary documentation (e.g., 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
A commitment to our employees lives at the core of our values.
We recognize their contributions.
They share in the success they help to create.
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
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)