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MANUFACTURING OPERATIONS QA DIRECTOR – BILLERICA, MA (on-site)

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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. Help bring the next generation of life-changing medical technology to patients worldwide. We reward you in the ways that matter most to you. At Medtronic we seek out and hire a diverse workforce at every level: We need fresh ideas and inclusive insights to continue to be an innovative industry leader that’s why we make it a point to seek out, attract and develop employees who are patient-centric, passionate, and who represent the same wide variety of life experiences as our patients.

The Manufacturing Operations QA Director will be based in Billerica and act as the Quality Site Lead for the Affera Campus, composed of manufacturing facilities in Billerica and Bedford. Supporting all Quality Direction for a 5 shift, 24/7 operation manufacturing Class III Medical Devices.

This position acts as the site quality leader for both sites to drive quality management strategies and activities resulting in the highest level of product quality and compliance. Emphasis will be on first time quality and continuous improvement of processes and systems and the execution of site quality strategy through direct accountability and influence within the operations organization. This position provides leadership and resources to ensure compliance with all elements of the quality management system throughout the organization and ensuring quality system performance is measured and routinely reported/ escalated to executive management.

Affera is part of the Medtronic Cardiovascular Portfolio. Our Cardiac Ablation Solutions offer cardiac mapping and ablation solutions to treat patients with abnormal heart rhythms. Our vision is to help patients worldwide by advancing innovation for the diagnosis and ablation of cardiac arrhythmias, enabling clinicians to perform procedures with superior outcomes.

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. To learn more, we invite you to visit Medtronic Benefits (https://benefits.medtronic.com/)

We believe that when people from different cultures, genders, and points of view come together, innovation is the result — and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive. To learn more about Inclusion & Diversity at Medtronic Click Here (https://www.medtronic.com/us-en/about/careers/diversity-inclusion.html)

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

• Leads a manufacturing site(s) to excellence in product quality, operational excellence, and a culture of putting patients first.

• Drives the combined Quality and GOSC strategies to deliver results.

• Interacts with and influences leaders across multiple leadership teams (Core Quality, OUs, and GOSC).

• 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.

• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.

• May develop, evaluate, implement, and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.

• Organizes the coordination of activities with outside suppliers and consultants to ensure timely delivery.

• Proactively manages quality assurance and compliance activities in order to produce the highest quality products and prevent defects.

• Creates a culture of continuous learning across areas of responsibilities where root causes on quality issues are identified and organizational learning is institutionalized.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements and your permanent address are evident on your resume.

• Bachelor’s degree required.

• Minimum of 10 years of relevant Manufacturing Quality / Engineering experience within the Medical Device / Pharmaceutical Industry with 7+ years of managerial experience, or advanced degree with a minimum of 8 years of relevant Manufacturing Quality / Engineering experience within the Medical Device / Pharmaceutical Industry with 7+ years of managerial experience.

Nice to Have

• Experience in Medical, Pharmaceutical or highly regulated product industry.

• DMAIC Lean / Six Sigma Certification and demonstrated experience leading DMAIC Projects.

• Demonstrated experience leading Kaizen Events.

• Experience in multiple Quality related functions.

• Highly results oriented and focused on business priorities.

• Strong leadership and influencing skills to drive results in a highly matrixed organization.

• Strong Business and Quality perspective.

• Strong change management and transformation skills.

• Strong understanding of Process Validation and statistical methods.

• Excellent Communication/Presentation Skills.

• Excellent Interpersonal and Talent Management skills.

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).

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. Learn more about our benefits here (https://www3.benefitsolver.com/benefits/BenefitSolverView?page_name=signon&co_num=30601&co_affid=medtronic) .

This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) here .

This position is eligible for an annual long-term incentive plan. Learn more about Medtronic Long-Term Incentive Plan (LTIP) here .

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).

" At Medtronic, most positions are posted on our career site for at least 3-7 days. "

Min Salary

173600

Max Salary

260400

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.