Senior Quality Engineer
Our client, a growing medical device company specializing in advanced cardiovascular disease detection systems, is currently seeking a Senior Quality Engineer to join their team. This person will be responsible for providing engineering support to ensure the quality of design, sourcing and manufacturing of life-saving technologies.
Qualifications:
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Provide input to the development teams in the manufacturing transfer of complex electromechanical medical devices.
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Develop, review, and implement engineering changes.
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Support the establishment of quality inspection criteria.
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Develop, establish and maintain quality engineering methodologies, systems and practices to meet customer and regulatory requirements
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Develop and validate test methods and inspection procedures. Participate in the development of test protocols and reports, as required.
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Execute and review engineering change orders.
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Define product acceptance and evaluate process capabilities.
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Participate in product risk analysis and FMEA analysis.
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Identify and implement effective process controls to support the development, qualification and manufacturing of products.
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Generate and assess quality metrics of trends that affect product quality. Identify non-conformance trends, perform failure analysis and drive corrective actions to resolve recurring problems through the CAPA process.
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Participate in developing inspection requirements for products, work-in-process, and procured components.
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Participate in NMR/MRB activities, including material disposition.
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Participate in internal and external audits and other quality system maintenance/improvement activities to be compliant with various regulatory standards and regulations, such as Management Review and Product Risk Reviews.
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Provide support to the complaint handling function, as required.
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Provide support in design control activities, as required.
Requirements:
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Bachelor of Science degree in a technical discipline – Electrical or Mechanical Engineering is preferred
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5 – 7 years of engineering in the medical device industry, experience with complex high volume disposables preferred.
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Strong written/verbal communication skills and demonstrated used of Quality tools/methodologies
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Microsoft (Word, Excel, PowerPoint) experience
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Working knowledge of 21 CFR 820, EU MDR, ISO 13485, ISO 14971, design verification, process validation, product design control, CAPA, FMEA and Kaizen methodologies
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ISO 19011 certification preferred
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Current ASQ certification preferred
If you are interested in this opportunity, please send your resume to [email protected]
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