Director, Post-Market Quality
Director, Post-Market Quality
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Job Description
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
We bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to do 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.This is an onsite role located in Lafayette CO.
As a Director of Post-Market Quality based in Lafayette CO you will lead a team responsible for ensuring the safety compliance and performance of our products after they reach the market. This role is critical to our mission of
alleviating pain restoring health and extending life.
As the Director of Post-Market Quality you will:
- Lead the post-market surveillance function including complaint trending signal detection and risk escalation.
- Oversee Field Corrective Action (FCA) activities ensuring timely and compliant execution across global markets.
- Serve as the primary liaison for regulatory agency inquiries related to post-market product performance.
- Direct product hold and release processes in collaboration with cross-functional teams.
- Partner with Regulatory Affairs Clinical R&D and Operations to drive continuous improvement and ensure product safety and compliance.
- Represent the Quality function in management reviews audits and strategic planning forums.
- Develop and mentor a high-performing team of quality professionals.
Must Have: Minimum Requirements
- Bachelors degree in Engineering Life Sciences or related field.
- 10 years of experience in Quality Assurance or Regulatory Affairs within the medical device industry (or 8 years with an advanced degree)
- 7 years of leadership experience managing teams and cross-functional initiatives.
- Deep knowledge of FDA QSR (21 CFR Part 820) ISO 13485 and global post-market regulatory requirements.
- Demonstrated success in managing complaint handling CAPA and field actions.
Nice to Have
- Advanced degree (MS MBA or equivalent).
- Experience with enterprise quality systems (e.g. TrackWise Veeva).
- Strong communication and stakeholder engagement skills.
- Experience interacting with FDA Notified Bodies and other regulatory agencies.
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 law. In addition Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
If you are applying to perform work for Medtronic Inc. (Medtronic) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County you can findhere a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.
Required Experience:
Director
Employment Type
Full-Time
