Sr. Quality Engineer Ref1817q

Job Description
The Senior Production Quality Engineer will work as a member of an integrated production team and is responsible for device history record review and preservation, release of final products, as well as the maintenance of and compliance to the program manufacturing/quality plans. Assures cGMP Quality Assurance policies, standards, instructions, and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment for an assigned complex project or area are maintained and product integrity is preserved. Ensure the highest quality levels area achieved and cost‑effective compliance is applied to align with contractual and Company requirements. Provide QA support to operations and engineering programs as assigned. Design and establish workmanship criteria for projects. Functional team member for assigned work areas to ensure product is shipped on time and per specification. Process non-conforming material reports, engineering change orders, complaints, CAPAs, and assist with training for line personnel. Performs quality on the floor audits and analyzes data used for decision-making purposes and drive quality metrics.
PRINCIPAL RESPONSIBILITIES
Assure Quality Assurance programs and plans are in place to provide and maintain the highest quality levels for an assigned project, product or area in accordance with contract requirements and product specifications. Assure the compliance of engineering and manufacturing program documents (good documentation practices) etc.
Recommend and implement methods and procedures for evaluating the precision and accuracy of assigned products or production equipment. Responsible for product compliance with contract requirements for reliability and performance.
Provide QMS support to inspection and operations personnel and establish workmanship criteria for projects, with specific emphasis on product quality audits and final QA acceptance of instruments and spares.
Evaluate non-conformance containment, disposition and product impact. Write technical and risk-based customer notices. Ability to document records for compliance and defend decisions made by the business/team in audits and inspections.
Perform root cause analysis and determine appropriate corrective and preventive actions and effectiveness criteria as required. Collaborate with customer, internal departments and others as needed.
Analyze statistical data to evaluate trends, investigate failures completely to determine the root cause and take appropriate corrective action to preventrecurrence.
Identify and correct instrumentation malfunctions, re‑designing or modifying complex test equipment, devising advanced applications of engineering technology to solve problems.
Review test techniques and methods for testing company products or components on the basis of product specifications and manufacturing processes. Analyze engineering orders for the effect on test procedures.
Oversee qualification and periodic testing requirements, initiating required customer reports and leading corrective action efforts on failures/defects.