- Provide rigorous assessment of CAPA activities and documentation to assure compliance with CAPA processes, FDA regulations, ISO 13485, and Medical Device Requirements through the review of CAPA records at critical phases
- Support and guide CAPA Board Leaders, and CAPA Owners regarding the CAPA process, CAPA record content, and CAPA software. Provide CRHF and CAPA Board Leaders with metrics and reporting on critical aspects regarding the health of the CAPA process.
- Support FDA and Notified Body inspection plans as a CAPA Program representative. Activity includes improvement and remediation activities.
- Provide guidance in interpreting government regulations, agency guidelines and Medtronic internal policies in general and specific to CAPA to assure compliance.
- Support the development and implementation of Quality System CAPA procedures, CAPA software, and CAPA training programs.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelor’s degree with 7+ years of work experience in Quality or regulated industry OR Advanced degree with 5+ years of work experience in Quality or regulated industry.
Nice to Have (Preferred Qualifications)
- Medtronic experience working directly with CAPA processes
- Previous work experience working with non-conformances, and corrective and preventive action reports
- Experience with quality tools and process improvement techniques such as Lean Sigma, Kepner-Tregoe
- Ability to process data and run statistical analysis to root cause, following flow diagrams, and producing process flow maps
- Database system experience (SAP, MRP, CAPA documentation systems such as Trackwise)
- Demonstrated strength in the review and writing of technical documentation
- Applied knowledge of effective root cause investigation and verification of effectiveness techniques
- Influence management skills; ability to work constructively across all functions of the organization
- Pro-active, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships
- Strong analytical skills. Reliable and timely decision maker (decisions based on relevant information, alternatives, risk).
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. Let’s 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)