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Medtronic, Inc.

Director, Quality Engineering/Site Leader

Medtronic, Inc. - Louisville, CO









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Job Title

Director, Quality Engineering/Site Leader




Louisville, CO, 80027, USA


Director, Quality Engineering/Site Leader


Louisville, Colorado, United States

Requisition #:


Post Date:

Jun 28, 2017

Careers that Change Lives

Are you a passionate, dedicated and motivated Quality Director? In this exciting role you will will have the key responsibility for Medtronic Neurosurgery’s Louisville quality strategy, quality systems and compliance. You will provide leadership, strategic direction and set goals and objectives for the team/site.

Come for a job, stay for a career.

A Day in the Life-

In this exciting role you will:

•Demonstrate expert knowledge in quality and regulatory requirements including application of the regulations to ensure compliance. Implement process and system improvements to produce highest product and process quality.

•Serve as a key member and the quality function representative to the site leadership team. Represent key aspects of quality requirements, including center-led quality processes, while acting as an effective business partner.

•Manage Louisville’s relationships with the FDA, Notified Bodies (ie, DEKRA, BSI) and other external and internal quality and regulatory groups and agencies ensuring a common vision and best practices approach to compliance; liaise with the FDA and other global regulatory agencies to ensure all quality and regulatory reporting requirements are met.

•Serve as the management representative for the Louisville Quality System, developing and implementing a best-practices approach to quality systems to create a sustainable culture of quality.

•Create and implement a quality vision and strategy supported by innovative quality and regulatory compliance programs and infrastructure that sets the standard in proactively responding to legal, regulatory and other environmental factors and influences the design and manufacturability of Louisville products.

Must Have: Minimum Requirements

•B.A./B.S. in Engineering, Scientific, or related field required

•Master’s degree/MBA preferred


•10 years of relevant experience with increasing scope and responsibility


•Minimum of 7 years’ people management experience with proven ability to lead and motivate teams

It would be ideal if you also had the following experience:

Track Record: Proven track record of accomplishments and innovation establishing progressive quality organizations and programs; in-depth knowledge and expertise in leading-edge quality programs and all applicable federal and international regulations

Business Savvy, Solution-oriented “Architect”: High-energy, accountable and forward-looking; able to see larger business picture to identify and diagnose problems and craft solutions.

Culture Creation: Dynamic individual with the ability to shape culture and drive quality ownership and stewardship across all functions through building a comprehensive, best-in-class quality organization and strategy to align with business objectives.

Strategic Thinker/Change Agent: Persuasive individual with the ability to work at all organizational levels, including site leadership, to educate and gain buy-in for all programs and initiatives.

Coach Captain: Effectively challenge and influence others functional leaders to “own” implementation of quality vision and strategies; must be an approachable and trusted confidant, able to encourage confidence to receive ‘unfiltered truth’ about potential problems at all levels; lead and manage quality function and staff, as well as peers on programs and initiatives.

Drive/“Get it done” Attitude- Must be a hands-on leader and practical thinker, able to identify and devise realizable solutions and roll-up sleeves to get things done; able to identify and alleviate potential hurdles to achieving objectives, successfully manage people and projects, both directly and through influence.

Medical capital equipment including software

Strong product development and risk management experience

ASQ Certified CQA, CQE, CQM

RAPS Certified

Deep knowledge and effective working with both domestic and international regulations and agencies including FDA QSR, ISO 13485/9001, MDD, CMDCAS, SFDA, JPAL MHLW, ANVISA and other regulations/agencies.

Australian Medical Device Regulations Department of Health, Therapeutic Goods Administration (TGA) requirements set forth in Therapeutic Goods Regulations 1990, Therapeutic Goods Act (Medical Devices) Regulations 2002, Therapeutic Goods Amendment Regulations 2010, and Australian Regulatory Guidelines for Medical Devices (ARGMD) 2011

Brazilian Good Manufacturing Practices RDC No. 16/2013, Technical Regulation of Good Manufacturing Practices of Medical Devices and In Vitro Diagnostic Devices Requirements for Proof of GMP for Registration Processes RDC 15/2014 National Health Surveillance Agency - ANVISA (Agência Nacional de Vigilância Sanitária).

Continuous quality improvements are built into our “Quality Begins With Me” culture.

Do meaningful work, make a difference, and improve lives — starting with your own.

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6 days

Medtronic, Inc.


Director, Quality Engineering/Site Leader Medtronic, Inc. - Louisville, CO, United States


Location: Louisville, CO

Company Profile:
Medtronic, Inc. manufactures and sells device-based medical therapies worldwide. The company operates in two segments, Cardiac and Vascular Group, and Restorative Therapies Group. The Cardiac and Vascular Group’s products include pacemakers; implantable defibrillators; leads and delivery systems; ablation products; electrophysiology catheters; products for the treatment of atrial fibrillation; information systems for the management of patients with cardiac rhythm disease management (CRDM) devices; coronary and peripheral stents and related delivery systems; therapies for uncontrolled hypertension; endovascular stent graft systems; heart valve replacement technologies; cardiac tissue ablation systems; and open heart and coronary bypass grafting surgical products. The Restorative Therapies Group offers products for various areas of the spine; bone graft substitutes; biologic products; trauma, implantable neurostimulation therapies, and drug delivery devices for the treatment of chronic pain, movement disorders, obsessive-compulsive disorder (OCD), overactive bladder, urinary retention, and fecal incontinence and gastroparesis; external insulin pumps; subcutaneous CGM systems; products to treat conditions of the ear, nose, and throat; and devices that incorporate advanced energy technology. It also manufactures and sells image-guided surgery and intra-operative imaging systems; and provides Web-based therapy management software solutions. The company serves hospitals, physicians, clinicians, and patients in approximately 140 countries. Medtronic, Inc. was founded in 1949 and is headquartered in Minneapolis, Minnesota.