The Design Quality Engineer shall provide support to new product development projects. Serve as a subject matter expert on the requirements and processes for product lifecycle management.
Duties and Responsibilities (Key Deliverables):
1. Ensures that product development projects and changes to current products are conducted in compliance with the FDA Quality System Regulation Design Phases and within the Quality Management System.
2. Participates in cross-functional teams to review requirements to develop product requirements that support the marketing needs through the product life cycle.
3. Aid in the transfer of design requirements to manufacturing (Manufacturing or suppliers) as part of New Product Development.
4. Aid in the in sourcing of new and previously released products to Manufacturing.
5. Aid in the transfer of design requirements for additional suppliers for previously released products.
6. Aid in the development and release of Process Failure Modes Effects Analysis (pMEA).
7. Aid in the development and execution of Manufacturing process verification and validations.
8. Participates in cross-functional team to develop risk management files (plans, assessment and reports).
9. Reviews new and modified product design for quality characteristics and develops the quality inspection plans.
10. Provide Quality support to facilitate resolution of product nonconformity.
11. Leads and/or participates in company-wide Corrective and Preventive Actions projects.
12. Assist in the inspection, investigation and documentation of product customer complaints.
13. Responsible for product and process change review and approval.
14. Direct or assist inspection training for QC inspectors and QE technicians.
15. Assist and support other team members as necessary.
16. Know and apply the Quality System and any appropriate Federal and International standards.
17. Assist and support other team members as necessary.