Two Director Openings: Quality Systems or Compliance / Audit

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. Two Director Openings: Quality Systems or Compliance / Audit Medtronic. Careers with a passion for life. As the world's leading medical technology company, we provide lifelong solutions to people with chronic disease. Every 5 seconds the life of someone somewhere in the world is improved by a Medtronic product or therapy. We also are dedicated to the total well-being of our employees and have been recognized for eight of the last ten years by Fortune magazine as one of the 100 Best Companies to Work For. Work with the kind of people who not only love what they do but why they do it.  Quality Systems Director (Redmond, WA)Position Description Develop, establish, and maintain quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction. Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to ensure compliance. May serve as a liaison between the company and various governmental agencies. Provide leadership for customer-focused quality, quality systems improvements, and business process improvement initiatives. Position Responsibilities 1. Oversee generation and review of documents used in good manufacturing practices; monitor audits of production and quality control areas. 2. Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance and effectiveness. 3. Work in close collaboration and partner with other Physio-Control functions, including manufacturing, Finance/IT, Human Resources, Quality and Regulatory, Supply Chain, Research & Development, and Clinical to optimize overall operational efficiency and effectiveness. 4. Manage document control and oversight of related quality systems – such as training system, electronic quality systems, etc. – to ensure effectiveness. 5. Participate with peers in the formulation of overall direction, processes, systems and talent development for the Quality organizations. 6. Perform other related duties as assigned. Basic Qualifications • Bachelor’s degree in a technical or scientific field, preferably engineering • Minimum of 8 years’ experience in quality and regulatory for medical devices and/or pharmaceuticals • Minimum 6 years’ management experience in a complex environment • Comprehensive knowledge of GMP and ISO 13485:2003 regulations, product design, manufacturing, supply chain, and distribution processes. Desired/Preferred Qualifications • Master’s degree in business or science • Prior experience managing the quality system in a manufacturing environment • Broad understanding of US and International regulations including 21 CFR, 820 • Influence management skills; demonstrated ability to work constructively across all functions of the organization • Experience presenting, interacting, and building effective relationships with regulatory agencies • Excellent communication and presentations skills (articulate and persuasive) • Strong team management and leadership skills. Ability to create strategies, define and articulate clear role expectations and direction. Ability to translate quality initiatives into specific objectives, metrics, and action plans • Willingness to “do what it takes,” including direct auditing activities at times • Ability to attract, develop, and retain diverse talent • Proven experience in achieving results through influence management and motivating teams Physical Job Requirements • Fast-paced office environment; requires significant use of telephone and computer keyboard, monitor, and mouse • May require domestic and international travel (10-20%)  With people like you who have purpose, potential and passion, we'll supply physicians and their patients around the world with the means to alleviate pain, restore health and extend life.To route your resume directly to the hiring department, visit: www.medtronic.com/employment select Job Opportunities-U.S. & Puerto Rico, then enter Requisition 60490 and apply online using **Apply to this Job** or **Add to Cart**. Please, no phone calls from agencies. Medtronic is an equal opportunity employer committed to cultural diversity in the workforce.   Compliance and Audit Director (Redmond, WA) Position Description Direct the coordination and preparation of internal and external audits and compliance in accordance with regulatory standards. Develop, implement, and maintain appropriate audit practices and compliance processes. Interpret federal and international regulations, and implements policies and procedures to ensure that these are in compliance with the appropriate statutes and regulations, and that regulatory reporting requirements are met. Position Responsibilities 1. Direct audit and compliance activities for the Physio-Control business, and coordinate audit follow-up and correction action planning. 2. Lead the management review process and response. 3. Provide guidance on interpretation and application of specified regulations. 4. Work directly with operating entities to ensure that inspections and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications. 5. Direct and provide guidance for the site regarding external audit readiness, including policy development, best practice sharing, and training/coaching. 6. Develop positive and proactive approaches to regulatory compliance to ensure client satisfactions. 7. Oversee interactions during regulatory agency inspections; direct interactions with regulatory agencies on defined audit preparation and response matters. 8. Develop and implement programs designed to increase employee awareness and knowledge of compliance policies. 9. Participate with peers in the formulation of overall direction, processes, systems and talent development for the Quality organization. 10. Perform other related duties as assigned. Basic Qualifications • Bachelor’s degree in a technical or scientific field, preferably engineering • Minimum of 10 years’ experience in quality and regulatory in a manufacturing environment • Minimum 6 years’ management experience in a complex environment • Significant experience in compliance auditing in medical device, pharmaceutical, and/or a comparable regulated environment, with a solid working knowledge of Medical Device Regulations and Auditing processes Desired/Preferred Qualifications • ASQ certified auditor or lead auditor certification • Must be thoroughly familiar with the FDA and ISO 13485:2003 requirements associated with developing and manufacturing medical devices • Broad understanding of US and International regulations including 21 CFR, 820 • Influence management skills; demonstrated ability to work constructively across all functions of the organization • Experience presenting, interacting, and building effective relationships with regulatory agencies • Excellent communication and presentations skills (articulate and persuasive) • Strong team management and leadership skills. Ability to create strategies, define and ar5ticulate clear role expectations and direction. Ability to translate quality initiatives into specific objectives, metrics, and action plans • Willingness to “do what it takes,” including direct auditing activities at times • Ability to attract, develop, and retain diverse talent • Proven experience in achieving results through influence management and motivating teams Physical Job Requirements • Fast-paced office environment; requires significant use of telephone and computer keyboard, monitor, and mouse • May require domestic and international travel (10-20%) With people like you who have purpose, potential and passion, we'll supply physicians and their patients around the world with the means to alleviate pain, restore health and extend life.To route your resume directly to the hiring department, visit: www.medtronic.com/employment select Job Opportunities-U.S. & Puerto Rico, then enter Requisition  60491 and apply online using **Apply to this Job** or **Add to Cart**. Please, no phone calls from agencies. Medtronic is an equal opportunity employer committed to cultural diversity in the workforce.   To Apply: Click Apply Now to route your resume directly to the hiring department. No agencies or phone calls, Please Medtronic is an euqal opportunity employer committed to cultural diversity in the workforce. www.medtronic.com/employment   Click here to see other Medtronic opportunities  Email this Job to a Friend