Senior Quality Engineer - Daley and Associates

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: 

• Provide input to the development teams in the manufacturing transfer of complex electromechanical medical devices. 

• Develop, review, and implement engineering changes. 

• Support the establishment of quality inspection criteria. 

• Develop, establish and maintain quality engineering methodologies, systems and practices to meet customer and regulatory requirements

• Develop and validate test methods and inspection procedures. Participate in the development of test protocols and reports, as required.

• Execute and review engineering change orders.

• Define product acceptance and evaluate process capabilities. 

• Participate in product risk analysis and FMEA analysis.

• Identify and implement effective process controls to support the development, qualification and manufacturing of products.

• 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.

• Participate in developing inspection requirements for products, work-in-process, and procured components.

• Participate in NMR/MRB activities, including material disposition.

• 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.

• Provide support to the complaint handling function, as required.

• Provide support in design control activities, as required.

Requirements:

• Bachelor of Science degree in a technical discipline – Electrical or Mechanical Engineering is preferred

• 5 – 7 years of engineering in the medical device industry, experience with complex high volume disposables preferred.

• Strong written/verbal communication skills and demonstrated used of Quality tools/methodologies

• Microsoft (Word, Excel, PowerPoint) experience

• Working knowledge of 21 CFR 820, EU MDR, ISO 13485, ISO 14971, design verification, process validation, product design control, CAPA, FMEA and Kaizen methodologies

• ISO 19011 certification preferred

• Current ASQ certification preferred

If you are interested in this opportunity, please send your resume to apowell@daleyaa.com


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