Senior Manager, MR Quality and Regulatory

Philips Electronics North America Corporation in Cleveland


We simplify healthcare by focusing on the people in the care cycle patients and care providers. Through combining human insights and clinical expertise, we aim to improve patient outcomes while lowering the burden on the healthcare system. Philips delivers advanced solutions for both health professionals, to meet the needs of patients, and empowered consumers for affordable healthcare whether in hospital or at home.

Some product highlights: 256-slice Brilliance iCT scanner, Integrated cath lab, Avalon FM 20 & FM 30 fetal monitors, Ambient Experience MR and CT systems, Philips Lifeline's personal emergency alert service.

MR Quality and Regulatory

Your Responsibilities:
POSITION SUMMARY
Responsible to manage the Quality & Regulatory group, maintain Quality & Environmental Management Systems, and play a vital role in ensuring the sustainability program is properly implemented within the MR business at the Cleveland facility.

JOB DUTIES AND RESPONSIBILITIES
Responsible for establishing, leading, and facilitating quality, regulatory, and process improvement initiatives.
Responsible for establishing and maintaining a complaint handling and CAPA systems.
Ensure internal Quality System audit program is planned and implemented.
Ensure that local project teams have adequate Q&R support.
Maintain databases to track and monitor key performance indicators.
Provide Q&R support to MR BU, Imaging Systems and Healthcare for defined projects.
Provide excellent people leadership by attracting, retaining and motivating talented people, ensuring development plans are in place for all and ensuring effective diversity. Managing performance and non-performance.
Responsible for financial performance of departmental including expense control, staffing plans, budget preparation and quarterly forecasts

Your Profile:
Bachelor as degree in Engineering / Science or related field. Advanced degree is a plus. Professional quality (ASQ or equivalent) is a plus.
10+ years experience in the medical device industry, with MR experience preferred.
Project Management and/or management experience
Process oriented with strong facilitation and leadership skills.
Medical Device regulatory experience, a strong plus.
Advanced PC skills, with strong working knowledge of work-tools software, including word processing, spreadsheets, database software and web use.
Good analytic, communication and teamwork skills.
Software QA and reliability experience preferred.
Database development and support a strong plus.
Travel (domestic and international) as appropriate, including to other Philips facilities.

Philips is an equal opportunity employer.

Published at 05-11-2010

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