CANDIDATES MUST HAVE AT LEAST 3 YEARS OF DESIGN-RELATED EXPERIENCE IN A REGULATED ENVIRONMENT

Position Description (Principle Duties and Responsibilities)

The Sr. Design Quality Assurance Engineer role is in support of a recent company acquisition, where the QMS of an acquired company must be merged with our clients' existing QMS. 

• Experience in process flow mapping and documentation desired. 
• Gather and analyze data to identify opportunities for quality improvements. 
• Drive failure investigation to root cause when applicable using known engineering problem-solving techniques. 
• Conduct/Update risk analyses and track all findings, along with the development of a Risk Management portfolio, as required. 
• Lead and/or Support NC/CAPA process and NC/CAPA Investigations stemming from Post market.
• Resolve Potential Medical device reporting(MDR) investigations.
• Document each investigation thoroughly in accordance with internal procedures within complaint handling system(s).
• Provide Service Report and Complaint trending.
• Manage projects in a timely manner. Participate in internal and external audits, as required. 

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Requirements

• Bachelor's Degree in applicable engineering discipline preferred: Biomedical, Process or Mechanical Engineering
• Minimum of 5 years of engineering experience with a preference for at least 3 years of design-related experience in a regulated environment. 
• Professional certification in a quality subject matter (e.g., MS, CQE, CRE, Six Sigma) highly desirable 
• Agile development methodology experience is highly desired 
• Understanding and experience with product validation are highly desired 
• Understanding of Medical Device design controls is highly desired 
• Ability to read and interpret engineering drawings and other technical specifications preferred 
• Knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics) 
• The job requires attention to detail in making evaluative judgments based on the analysis of information.
• Competent with Microsoft Office (Outlook, Excel, Word, etc.) 
• Must possess excellent oral and written communication skills