At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. **A Day in the Life** A Day in the Life Act boldly. Compete to win. Move with speed and decisiveness. Foster belonging. Deliver results…the right way. That’s the Medtronic Mindset — our cultural norms. Our brand is rooted in action, not just words. The Medtronic Mindset defines the expectations of our culture. Every person here plays a role in bringing it to life. We recognize your extraordinary potential to ensure future generations live better, healthier lives. Responsibilities may include the following and other duties may be assigned. + Provide oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies. Ensure quality of services conforms to established internal and external standards and guidelines. + Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. + Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations. + Leads audit and inspection preparation. Resolve audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits. + Prepare reports and/or necessary documentation (ex. Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external. + Co-ordinate legal requests in support of government investigations. + Ensure the quality assurance programs and policies are maintained and modified regularly. + Facilitate uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally. **Must Have: Minimum Requirements** + Requires a Bachelor’s degree and minimum of 3 years of work experience in Quality in a regulated industry + Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. + Must meet the qualification requirements for a biological product manufacturing manager **Nice to Have** + Document Control experience + Working knowledge of Microsoft Office tools, desktop publishing software experience (Microsoft Office Suite, Adobe Acrobat) + Familiar with modern ERP (Enterprise Resource Planning) systems, PLM (Product Lifecycle Management) systems and manufacturing documentation (i.e. BOMs, item masters, DHF, DMR, etc.) + Excellent communication skills (oral and written) + Able to work independently and within a Team **DIFFERENTIATING FACTORS** Autonomy: Established and productive individual contributor. Can work independently with general supervision on larger, moderately complex projects or assignments. Organizational Impact: Can set objectives for own job area to meet the objectives of projects and assignments. Contribute to the completion of project milestones. May have some involvement in cross functional assignments. Innovation and Complexity: Can understand broader set of issues or other job areas. Can make adjustments or recommend enhancements to systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Can communicate primarily and frequently with internal and external contacts. Can proactively reach out to others to share information, status, needs and issues. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream. **SPECIALIST CAREER STREAM** : Typically, an individual contributor with responsibility in a professional discipline or specialty. Deliver and/or manage projects assigned and work with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education. **Physical Job Requirements** The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.  **Benefits & Compensation** **Medtronic offers a competitive Salary and flexible Benefits Package** A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). **About Medtronic** We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. Learn more about our business, mission, and our commitment to diversity here (http://www.medtronic.com) We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people. We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary. **We change lives** . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives. **We build extraordinary solutions as one team** . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough. **This life-changing career is yours to engineer** . By bringing your ambitious ideas, unique perspective and contributions, you will… + **Build** a better future, amplifying your impact on the causes that matter to you and the world + **Grow** a career reflective of your passion and abilities + **Connect** to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest: **Experiences that put people first** . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need. **Life-transforming technologies** . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms. **Better outcomes for our world** . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls. **Insight-driven care** . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care 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. For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support. 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 (https://www.e-verify.gov/employees) . For updates on job applications, please go to the candidate login page and sign in to check your application status. If you need assistance completing your application please email AskHR@medtronic.com To request removal of your personal information from our systems please email RS.HRCompliance@medtronic.com