QA Engineering support for existing products and products in development, as well as provide support for various Quality Management System programs and across all quality systems.

Key Responsibilities:

Support new product development activities including providing the quality plans, direction for the application of statistical techniques, reviewing and approving required design and development documentation, and participating in risk management activities and design reviews; ensure that quality plans include provisions for ensuring manufacturing goals for new products are established, verified, and maintained

Oversee supplier-related activities, including the supplier audit and supplier corrective action programs, and assisting the purchasing department in evaluating current and prospective suppliers with regard to compliance with related specifications and requirements

Assist with the management of the Complaint Handling program, including conducting periodic customer complaint review meetings, including presenting complaint trend data; ensuring customer complaint investigations are performed, including adequate root cause analysis; and providing recommendations for corrective and preventive actions to address product failure mitigation

Work with customer support and field representatives to solve product quality problems in the field Write and review procedures and work instructions related to product quality and the quality system Support the operation and maintenance of the ISO 13485-based Quality Management System as required Participate in problem solving and other work improvement activities Review designs and specifications Review and approve Product Review Requests Participate as a Material Review Board member Support the Controlled Documentation System

Education and Experience Requirements

BS in electrical engineering, bio-medical mechanical engineering, or manufacturing engineering Working knowledge of FDA QSR and ISO standards

If you are interested in learning more about these roles, please send resume to:

mtoohey@contractstaffingrecruiters.com