Product Quality Assurance Engineer Job #2799 Cleveland area, Ohio
Compensation: Commensurable
A local Cleveland area company is seeking a Product Quality Assurance Engineer to add to their Quality Control Department.
Requirements:
• B.S. in biomedical, electrical/electronic, mechanical, or industrial engineering discipline
• 8+ years of successful experience in a product design and product quality assurance position
• Knowledge and experience with FDA Quality System regulations
• Hands on experience and thorough knowledge of UL and IEC requirements for medical devices
• Experience in NRC regulated environment and knowledge of ISO and CE Mark requirements very preferable
• Experience developing and conducting complex, documented component, subassembly, and system validations in a medical device company under design control is preferable
• Ability to work independently as well as with teams supporting all Quality aspects in a Research and Development environment
• Ability to launch new initiatives and follow through the completion
Responsibilities:
• Provides technical transfer, new product introduction, change control, and validation support including specification and quality documentation review and approval.
• Audits and approves manufacturing, quality, engineering, and validation documents for conformance to business practices and departmental procedures.
• Monitor existing processes and interpret deviation. Determine root cause and lead team to correct situation from a Quality perspective.
• Continuously looks for opportunity to improve processes related to Quality and proactively lead teams
• Assist in definition of product development processes. Support Clinical Trials, prototype development.
• Serve as Quality liaison between Project Manager and R&D Engineers
• Ensure product requirements are measurable and verifiable through the use of metrics
• Develop and write test and validation plans for components, subassemblies, and systems as appropriate. Document all plans, inspection, test, validation activities to support regulatory requirements of medical devices
• Conduct and document design reviews. Coordinate required testing with external certification agencies for acceptance of company products
• Provides support to external manufacturing quality assurance
• Closely monitor agreed upon metrics with customer sites to proactively address opportunities
Compensation: Commensurable
You must reference Product Quality Assurance Engineer Job #2799 when applying to this position and email your resume to: .
Due to the large amount of resumes we expect to receive; only the most qualified candidates will be contacted. We will retain all other resumes for any future job considerations.
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Integrity Technical Services, Inc.
14 Whitehall Drive Suite 102
Akron, Ohio 44278
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Akron: Cleveland:
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