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Senior Quality Director

Brooklyn Park, MN 55443
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Senior Quality Director


Brooklyn Center, Minnesota, United States

Requisition #:


Post Date:

Feb 15, 2021

**Careers that Change Lives**

This is a leadership role within the Active Implantables and Pumps Manufacturing Network: the Medtronic Energy and Component Center (MECC) facility in Brooklyn Center, MN with responsibility for leading both quality strategy execution and day to day management oversight of product quality and compliance. The successful candidate will lead a team of quality professional to deliver annual quality plan objectives, provide oversight to product quality compliance in design, development, manufacturing and supply environment of all components, products/ services manufactured at the facility, ensuring we met or exceed the organizations performance expectations and customer needs. This position requires strong collaboration across the manufacturing networks partnering with Operations leaders, business leaders, other inter facility manufacturing sites, global partners i.e. supply chain, sourcing, reg affairs to ensure strategic alignment to deliver results. The successful candidate will participate with other senior leaders to embed a solid culture of quality, drive transformation programs with a relentless focus on serving our patients and stakeholders. He / she will lead decisions making processes on operational matters that may impact quality and actively promoting awareness of regulatory and customer requirements throughout the organization.

What does it take to be a leader at Medtronic? We look for inspiring and inclusive leaders who partner with others, knowing that diverse talent, skills, and perspectives lead to better outcomes.

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.

**A Day in the Life**

Responsibilities may include the following (other duties may be assigned):

+ Execution and delivery of the site quality commitments aligned with the Enterprise Quality and Ops strategies, with focus on delivering superior product quality, and a steadfast focus on continuous improvement.

+ Management, oversight and maintenance of the site QMS in accordance with Medtronic policies and external regulatory requirements.

+ Provide Quality leadership across the Operations, working in partnership with other functions including Operations, Source, Supply Chain, Post Market Quality, RA, Finance, HR etc.

+ Effectively influence and mobilize key stakeholders around the site quality vision and strategy, by engaging cross functional leaders in applicable quality strategic programs

+ Execute planned quality programs / initiatives as defined within the AIP quality and Ops strategies

+ Support the execution of strategic plans that include manufacturing site capacity expansions, technology roadmap deployments, process capability/control improvements, business continuity plans and talent development

+ Lead and / or support the improvements to Produce Product Quality system processes. (e.g., process validation fundamentals, design transfer, acquisition integration mgt)

+ Monitor , trend continuously improve manufacturing quality key performance indicators (KPIs) such as reduced NCR rates, reduced scrap, improved yields, CAPA on plan, CAPA effectiveness, Audit performance outcomes

+ Deliver on shared Quality / Operational goals i.e. cost down through the management and measurement of operations wide actions including quality, escapes, CAPA, product availability, scrap, cost-down, inventory, material flow, supplier management and obsolescence

+ Lead the diagnoses of current organization strengths, technical expertise and future-state opportunities and org capabilities through structured employee engagement approaches, identifying and prioritizing the critical initiatives, key improvement areas, leading the creation and active deployment of both the Quality vision and associated strategic plan of accelerated excellences in transformation

+ Generate innovative solutions and calculated vital actions for Quality Operations to achieve rapid improvement, transformative change, sustainable results while maintaining solid product quality performance and compliance

+ Drive high performance and career development planning process in partnership with HR. Build a diverse, highly engaged and effective organization by ensuring appropriate workforce plans, talent strategies, strong leader pipeline and succession plans are in place and supported

+ Establish and maintain effective working relationships with key stakeholders across matrix functions by becoming a key interface with, and advocate for, all groups

+ Establish and lead the QA operations organization ensuring a clear understanding of the Quality vision for the organization, establishing a strong quality and continuous improvement mindset, a culture of problem solving, by leveraging available lean principles, MOS, COS, FTQ involving everyone every day in Quality improvements

**Must Have: Minimum Requirements**

+ Bachelors degree

+ Minimum of 15 years of relevant operations and / or quality experience with 10+ years of managerial experience, or advanced degree with a minimum of 12 years of relevant operations and / or quality experience with 10+ years of managerial experience

+ 10 + years manufacturing experience in a regulated medical industry.

+ Minimum of10 years of experience leading Manufacturing and / or Quality Engineering functions

+ Minimum of5 years of experience leading continuous improvement utilizing tools such as Lean and Six Sigma

+ Experience transforming and improving processes, systems and culture with a demonstrated track record of process and productivity improvement and successful results with developing and implementing change initiatives

**Nice to Have: Preferred Requirements**

+ Masters degree in quality / engineering and /or an MBA

+ Experience in medical or high reliability product industry

+ Highly results oriented and focused on business priorities

+ Strong change management and transformation skills

+ Experience in drugs, devices, and combination products

+ Experience in developing annual operating plans and managing cost centers

+ Advance knowledge of various QS regulation (ex: FDA, EUMDR, MDSAP)

**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. Lets work together to address universal healthcare needs and improve patients lives. Help us shape the future.

**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.

The physical demands described within the Day in the Life 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.
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.


Posted: 2021-02-18 Expires: 2021-04-26
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Senior Quality Director

Brooklyn Park, MN 55443

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