At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll 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 resultsthe right way. Thats 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 dont 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 -person exchanges are invaluable to our work. Were 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.

Responsibilities may include the following and other duties may be assigned.

• 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 companys mission globally.

Must Have: Minimum Requirements

To be considered for this role please ensure the minimum requirements are evident in your applicant profile.

• Bachelorsdegree with 4 years of work experience in Quality or regulated industry OR Advanced degree with 2years of work experience in Quality or regulated industry

Nice to Have

• 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)

• 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

• Experience with internal and external audits

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation

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.

The following benefits and additional compensation are available to those regular employees who work 20 hours per week: Health Dental and vision insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees:Incentive plans 401(k) plan plus employer contribution and matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital Accumulation Plan (available to Vice Presidents and above or subject to IRS earning minimums).

Regular employees are those who are not temporary such as interns. Temporary employees are eligible for paid sick time as required under applicable state law and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below:

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.

Learn more about our business mission and our commitment to diversity here.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and/or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by federal state or local addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.