Principal Quality Compliance Auditor

JOB TYPE: Full Time, Employee JOB CATEGORY: Quality Assurance/Safety CITY: Redmond STATE: WAAbout Medtronic Benefits and Total Rewards It's challenging. It's energizing. It's rewarding. That's why our nearly 38,000 employees have chosen to spend their careers at Medtronic, a global leader in medical technology, providing lifelong solutions for people with chronic disease. Today, every 5 seconds the life of someone somewhere in the world is improved by a Medtronic product or therapy. Join us in our mission to alleviate pain, restore health and extend life, and discover why FORTUNE magazine named us one of the "100 Best Companies to Work For" eight of the last 10 years. Principal Quality Compliance Auditor Requisition Number: 64128Position Description Support Physio-Control’s Quality System by leading the internal audit program for Physio-Control’s manufacturing and supporting departments. Verify the implementation of the policies and procedures described in the documented quality system and the quality of Physio-Control products and services. Position Responsibilities 1. Ensure compliance to company quality system requirements including, but not limited to, QSR, FAA, MDD, CMDCAS, ISO standards and Japanese rPAL. 2. Manage the audit of all departments for compliance to company developed procedures, instructions, and guidelines and FDA/ISO requirements. Own the company audit schedule and ensure audits and audit follow-up activities are completed in a timely manner. 3. Ensure all audit activities include: • Develop audit schedule. • Prepare audit plan and checklist. • Conduct audit. • Document audit findings. • Conduct closing meeting with affected department. • Write reports and review corrective actions. • Review and approve corrective action response. • Facilitate corrective action process and prepare report to Management • Verify corrective action implementation. • Perform follow-up audit. • Maintain audit files. 4. Develop and distribute periodic reports on the status of the audit program to help drive continuous improvement. 5. Host external audits activities, and maintain records. 6. Participate in meeting departmental goals and objectives. 7. Act as a quality system expert/consultant for other team members. 8. Research new regulatory/standard decisions or rulings. 9. Review, comment on and approve changes to QP, WI, GD and GDR. 10. Conduct training in quality system (QSR/ISO13485) and other regulations. 11. Perform other related duties as assigned. Basic Qualifications • Bachelor’s degree in engineering, biological sciences or allied health care • 10 years of auditing experience in a regulated environment, with a minimum of 3 years serving in a lead auditor capacity • An equivalent combination of directly related experience and education may be considered equivalent to a bachelor’s degree for this position Desired/Preferred Qualifications • ASQ Certified Quality Auditor (CQA) • Demonstrated knowledge of QSR, MDD, CMDR, and ISO requirements and ability to apply that knowledge to audit activities • Project management certificate or demonstrated ability to manage large, complex projects or programs • Strong analytical skills, with the ability to analyze technical requirements and regulations that apply to the corporation • Excellent organizational, interpersonal, and communication skills • Demonstrated ability to interact effectively with external audit personnel and all levels of the organization internally • Demonstrated ability to operate in a changing environment and manage changes and priorities; understanding the holistic nature of and inter-relationships within the Quality System Physical Job Requirements • Office environment involving significant use of standard office equipment, including telephone equipment, computer keyboard, monitor, and mouse. • This position has no direct management responsibilities, but may serve as a team lead and/or mentor for less experienced audit team members.   To Apply: Click Apply Now to route your resume directly to the hiring department. No agencies or phone calls, Please Medtronic is an equal opportunity employer committed to cultural diversity in the workforce. www.medtronic.com/careers   Click here to see other Medtronic opportunities  Email this Job to a Friend