The Staff Quality Assurance Engineer supports new product development (instruments, reagents, consumables, and software) from a QA perspective. The primary role of the position is to provide guidance and direction to cross functional core teams to organize project structure and documentation to meet design control requirements in support of market release of new products. The position also supports post-launch design changes to established products.
RESPONSIBILITIES:• Provide strategic direction for new product development and design change teams in terms of quality functions including design quality, manufacturing quality, process validation, supplier quality, post-market quality and risk management.• Ensure proactive compliance to all applicable internal, domestic and international regulations including: US 21 CFR 820 (QSR), ISO 19471:2007 and ISO 13485:2016.• Ensure compliant and complete product documentation, inclusive of DHFs, with particular focus on design controls, risk management and document controls.• Lead extended Quality teams for new product development and design change projects. • Review and approve design and development documentation including: Design Development plans, Design Change plans, User Needs, Design Input and Design Output documents, Design Verification Protocols and Reports, Design Validation Protocols and Reports, Software Requirement documents and associated Software Verification test procedures and reports, and System Risk Assessment documentation.• May review and approve engineering drawings, specifications, procedures, engineering changes, manufacturing work instructions, etc. • Assures that newly developed products are successfully transferred into the supply chain including manufacturing and service environments.• Participates in Design Reviews and develop, approve and review associated documentation.• Responsible for Design History File (DHF) completeness and maintenance.• Utilize problem solving techniques ad take a broad perspective to identify innovative solutions. • Interact frequently with other functional areas and operating entities which requires specialized depth and/or breadth of expertise
QUALIFICATIONS: • Bachelor’s degree in engineering or science discipline with seven years of experience in a regulated environment or Master’s degree in engineering or science discipline with five years of experience in a regulated environment.• Experience in application of design controls in accordance with 21 CFR Part 820, ISO 13485, and ISO 9001 for the development of products and design change• High level of autonomy and critical thinking is required. Teamwork oriented.• Must be able to multi-task and prioritize in a fast-paced environment. • Must have strong verbal and written communication skills and be capable of producing detailed and comprehensive quality system documentation and reports. • Computer skills (MS Office products).• ASQ Certified Quality Engineer (CQE) is preferred.• Ability to travel up to 10%