Principal Quality Systems Specialist

Company: Medtronic GmbH
Location: Irvine
Posted on: February 23, 2021

Job Description:

Written in 1960, our Mission dictates that our first and foremost priority is to contribute to human welfare. Over a half-century later, the Mission continues to serve as our ethical framework and inspirational goal for our employees around the world.-- In this exciting role as a Principal Quality Systems Specialist you will have responsibility for leading the CAPA process, QMS Harmonization, and Audit support activities for the Medtronic Neurovascular business. A Day in the Life Responsibilities may include the following and other duties may be assigned.

• 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 assure 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 (ex 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.
• Travel requirement: less than 25% 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
  • Degree in Science or Engineering
  • Experience working with CAPA, Management Review, Change Control and Audit processes.
  • Experience with TrackWise and Agile PLM software
  • Understanding of 21CFR 820, 806, 803, Part 11, Part 4; ANVISA, TGA, Health Canada, EU, China & Japan regulations; ISO 13485, MDSAP, etc.
  • Knowledge of effective root cause investigation, corrective and preventive action planning, execution and verification of effectiveness techniques. Experience with quality tools and process improvement techniques.
  • Influence management skills; ability to work constructively across all functions of the organization and build relationships as well as with external customers and regulators.
  • Independent compliance decision maker (based on knowledge of regulations, available relevant information, alternatives, risk).
  • Experience reviewing technical documentation.
  • Strong written and verbal communication skills
  • Strong critical thinking and analytical skills
  • Lean Sigma certified or demonstrated problem solving experience
    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. 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) 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. This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here .

Keywords: Medtronic GmbH, Irvine , Principal Quality Systems Specialist, Other , Irvine, California