Careers that Change LivesA career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people. Help us engineer the extraordinary!Bring the next generation of life-changing medical technology to patients worldwide. We reward you in the ways that matter most to you. We offer a wide range of benefits and rewards programs to recognize the important role you play in our Mission to transform healthcare. Learn more about Medtronic benefits and compensation at the bottom of this job description.We are currently looking for a Senior Quality Systems Director to join our Cranial and Spinal Technologies operating unit (CST). This position will be based onsite in Lafayette, Colorado.A Day In the LifeIn this exciting role, a day in the life as a senior leader in medical device quality systems can be quite varied and dynamic. You will be responsible for developing, implementing, and maintaining robust quality management systems in the Cranial and Spinal Technologies Operating Unit to ensure compliance with regulatory requirements and industry standards. This position will play a key role in driving a culture of quality excellence and continuous improvement throughout the organization. You will manage a team of professionals and will be accountable for mentoring, developing, and coaching them on meeting/exceeding performance expectations and defined objectives, and providing leadership to ensure the prioritization of strategic and department level initiatives.Responsibilities will include but are not limited to:
Define quality objectives and set priorities for quality improvement initiatives, developing strategies to enhance compliance with regulatory requirements, evaluating new technologies or processes to streamline quality systems.
Define performance goals and targets; conduct hiring, performance reviews, and 1:1s to guide performance management and employee development efforts and manage toward departmental goals.
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.
Lead audit and inspection preparation, resolution of audit and inspection findings and liaise with auditing groups and inspectors through all stages of the audits.
Prepare reports and/or necessary documentation (e.g., Corrective and Preventative Actions) and provide to applicable stakeholders, both internal and external.
Facilitate uniform standards worldwide and enable best practice sharing, thereby fostering the achievement of company's mission globally.
Stay informed about emerging trends, best practices, and regulatory changes in the medical device industry, and proactively identify opportunities for process improvements and risk mitigation.
Frequently communicates with higher level business unit, operating unit and portfolio leadership. Leads briefings and meetings with internal and external contacts.
Drives fiscal accountability to cost center AOP.
Travel: approximately 25%
Must Have: Minimum RequirementsTo be considered for this role, please ensure the minimum requirements are evident in your applicant profile and on your resume.
Bachelors degree in a technically related field is required
Minimum of 15 years of relevant experience with 10+ years of managerial experience , or Advanced Degree with a minimum 13 years prior relevant experience, minimum of 10 years of managerial experience
Nice to Have: Preferred Qualifications
Advanced management and leadership experience to lead cross-department project teams or manage across multiple functions.
Medical Device Quality Systems experience.
Prior experience working across some or all Medical Device risk classes (U.S. FDA classifications - Class I, II, III), Software as a Medical Device (SaMD), Combination Products, and/or HCT/P products.
Experience leading quality audits and inspections by regulatory agencies and notified bodies.
Experience with standards and regulations including ISO 13485, Medical Device Directives, European Union Medical Device Directives, Medical Device Reporting, Quality System Regulation, and FDA requirements.
Ability to lead within complex organizations requiring strong influence management skills.
Good communication (oral and written), presentation and interpersonal skills.
Ability to work cooperatively at all levels in a matrix environment to build and maintain the positive relationships required to accomplish organizational goals.
About MedtronicTogether, 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.Benefits & CompensationA 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). Learn more about MIP and benefits here (https://www3.benefitsolver.com/benefits/BenefitSolverView?pagename=signon&conum=30601&coaffid=medtronic) .The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).Physical Job RequirementsThe 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.Min Salary211200Max Salary316800It 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.