Senior Quality Engineer

Senior Quality Engineer

Provide engineering support to ensure the quality of design, sourcing and manufacturing of products at Infraredx. Provide input to the development teams in the manufacturing transfer of complex electromechanical medical devices. Develop, review, and implement engineering changes. Support establishment of quality inspection criteria. Develop, establish and maintain quality engineering methodologies, systems and practices to meet customer and regulatory requirements.

Key Responsibilities:

• 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, prioritize, communicate and resolve quality issues given a fast-paced environment and dynamic business needs
• Support monitoring and certification of controlled environment
• 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 medical device industry
• Strong written/verbal communication skills and demonstrated used of Quality tools/methodologies
• Microsoft (Word, Excel, Powerpoint) experience
• Working knowledge of 21 CFR 820, MDD/MDR, ISO 13485, ISO 14971, design verification, process validation, product design control, CAPA, FMEA and Kaizen methodologies
• Must be able to work independently and as a member of a cross-functional team, to multi-task and meet tight deadlines
• ISO 19011 certification preferred
• Current ASQ certification is preferred
• Must be able to interface with all levels in a company