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Senior CAPA Specialist - Louisville , Colorado
Medtronic
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LIVE YOUR MISSION
As the world's leading medical technology company, we provide lifelong solutions to people with chronic disease. Everything we do is deeply rooted in our mission-to alleviate pain, restore health, and extend life. In fact, every 5 seconds the life of someone somewhere in the world is improved by a Medtronic product or therapy. Work with the kind of people who not only love what they do but why they do it.
Senior Capa Specialist
Category: Engineering
Business: Surgical Technologies
Division: Surgical Navigation Tech
Location: USA-CO-Louisville
Job Type: Full Time - Regular
Position Description
Provides technical support to all areas of Medtronic Navigation by gathering, organizing and analyzing the data generated by the Corrective and Preventive Action (CAPA) system. Verify the implementation of the policies and procedures described in the documented quality system related to CAPA. Coordinate CAPA systems to ensure corrective/preventive measures are documented, implemented and measured for effectiveness. Develop, maintain, and communicate metrics on the CAPA system to ensure timely and accurate information regarding the functioning of the system is communicated and escalated within the organization.
Assure the timely, accurate and independent evaluation of product performance and compliance to safety and regulatory requirements prior to market release of products. Support design changes and perform quality analysis of released products. Collaborate with suppliers to ensure product specifications are met. May specialize in areas such as CAPA, design quality assurance, incoming quality assurance, production and inventory control, process validations, and/or supplier management. .
Basic Qualifications
EDUCATION REQUIRED
o B.S./B.A. in Engineering or similar related field
YEARS OF EXPERIENCE
o 5+ years of previous experience in an engineering position with B.S./B.A.
o 3+ years of previous experience in an engineering position with M.S./M.A.
Desired/Preferred Qualifications
o Excellent verbal and written communication skills.
o Ability to work in a team environment.
o Previous experience in a regulated environment.
Visit Medtronic.com/careers to learn more about other opportunities nationwide, in the Medical Device industry, including Service & Clinical Support, Program Management, Quality Engineering, EHS Engineering and Regulatory & Compliance.
Please visit http://jobs.medtronic.com (job #74705) for a full job description and to submit your profile.
Medtronic is an equal opportunity employer committed to cultural diversity in the workforce.
Primary Skills: CAPA, Engineering
Salary: Between DOE - DOE
Experience Required: Experienced, 5 years minimum
Clearance Level: none
Travel: 15 %
Other Details:
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