Principal CAPA Compliance Specialist

Location:

Boulder, Colorado, United States

Requisition #:

220003TP

Post Date:

Mar 10, 2022


**Principal CAPA Specialist**

**Boulder, CO or Minneapolis, MN or Northridge, CA**

**220003TP**


**Careers that Change Lives**


As a **Principal CAPA Compliance Specialist** you will have responsibility for leading and coordinating the Medtronic Customer Quality CAPA Portfolio. Management includes partnering with those team members to detect, investigate, execute, and resolve product and quality systems issues to ensure they dont recur. By supporting the Customer Quality Function, you will provide critical compliance guidance and direction for CAPA impacting Complaint Reporting, Regulatory Reporting, PHO and FCA .


Our **Global Quality Strategy** is rooted in the Medtronic Mission and our Quality Policy. Being a trusted partner means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs.


**Day in the Life - Responsibilities**


+ Acts as the SME and Project Lead for ensuring Customer Quality related CAPAs are integrated into the strategy and planning for the broader teams effectively.

+ Seeks to maximize compliance and efficiency while managing various CAPA Investigations and Action-Plans. Ensures that CAPA solutions are robust and can be implemented fully within our CQ structure.

+ Collaborates with those in CQ and in other functions to maintain quality systems policies, procedures, and practices.

+ Ensures alignment with quality and ethical standards of the organization.

+ Provides quality/CAPA-related oversight and investigates various input sources to verify deficiencies are corrected.

+ Analyzes metrics, generate reports, and implement improvements to KPIs and enterprise-initiatives.

+ Ensures the CAPA program, including their records, are audit-ready all the time by mentoring CAPA owners, ensuring the documentation is technically sound, and supporting audits as a CAPA program SME.

+ Develops, implements, administers and certifies compliance policies, procedures, and practices.

+ Ensures alignment with legal and ethical standards of the organization.

+ Provides compliance advice, investigates complaints and verifies deficiencies are corrected.

+ Travel requirement: Less than 10%


**Must Have: Minimum Requirements (Must be evident on your resume)**


+ Bachelors degree with

+ 7+ years of experience in Quality in medical device and/or regulated industry


OR


+ Advanced degree with 5+ years of experience in Quality in medical device and/or regulated industry.


**Preferred**


+ 8+ years quality experience in the medical device industry

+ Experience with the CAPA process (owning a CAPA, CAPA Board Member, etc).

+ Experience with supporting and/or leading complex projects.

+ Experience supporting and participating in audits (MDSAP, EUMDR, FDA, other geography)

+ Experience with multiple root cause investigation techniques

+ Experience with the Trackwise application.


**About Medtronic**


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.


We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.


**Physical Job Requirements**


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. (ADA-United States of America)
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.