Senior Quality Assurance (QA) Engineer
Partial Job Description
1) Participate in the design of medical devices and components from design initiation through design transfer by representing Quality Assurance in all design and development project teams
2) Lead multifunctional new product project teams in developing risk assessments, design inputs, test and inspection procedures, acceptance criteria and complaint analysis
3) Determine necessity of testing and initiate testing of assigned products by preparing test and inspection plans and identifying and obtaining required test fixtures and test/inspection instrumentation
4) Develop MRB activities for assigned products, timely resolution of nonconformities, issuing and monitoring corrective actions associated with non conformance and deviations
5) Provide input and direction to other members of the quality assurance department to assist them in their assignments and provide them with learning experience
6) Supervise, assign and coordinate the work of others on projects and assignments as appropriate
7) Assist in the maintenance of design history files for assigned projects, adhering to company design control procedures and performing periodic review of design history files to ensure timely design transfers
8) Support manufacturing suppliers through audits, corrective and preventive actions, assistance in on-site resolution of quality and process related issues
9) Ensure to report progress and status of assigned projects on a timely basis with emphasis on reporting results to Director of Operations
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Qualifications / Skills Required
1) Bachelors Degree preferably in an Engineering or Science discipline
2) Minimum 7 years of experience in a Quality Control or Quality Assurance position in a Medical Device Company (preferred)
3) Experience in medical device capital equipment and software validation (preferred)
4) Working knowledge of risk assessments, design control, testing and inspection of equipment and techniques as they relate to their device responsibilities
5) Knowledge of manufacturing process
6) Technical knowledge in development methodologies, design and project implementation, including, but not limited to GD&T
7) Proficiency in drawing changes using a 3D-CAD program to add, modify and delete quality requirements
8) Proficiency in the use of PC and programs, particularly Excel, Word (or equivalents if changed by the Company), QAD or similar inventory software
Sterling-Hoffman Life Sciences is the premier recruitment firm in North America for companies involved in the research, clinical development, manufacturing and distribution of drugs and devices that allow patients to live healthier and more fulfilling lives. Leveraging a network of relationships in every major city – including New York, San Francisco, Raleigh-Durham, Chicago, Dallas, Denver and Los Angeles – Sterling-Hoffman Life Sciences is ideally positioned to assist fast growing CROs, pharmaceutical companies, biotech firms and medical device players in their quest to recruit the best people.