What are the responsibilities and job description for the Design Quality Engineer position at Exactech?
Department: Quality
Location: Gainesville, FL
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.
Key Responsibilities
- Ensures that product development projects and changes to current products are conducted in compliance with the FDA Quality System Regulation Design Phases and within Exactech Quality Management System.
- Participates in cross-functional teams to review requirements to develop product requirements that support the marketing needs through the product life cycle.
- Aid in the transfer of design requirements to manufacturing (Exactech Manufacturing or suppliers) as part of New Product Development.
- Aid in the insourcing of new and previously released products to Exactech Manufacturing.
- Aid in the transfer of design requirements for additional suppliers for previously released products.
- Aid in the development and release of Design Control Documentation (Design Transfer Matrices, Design Verification & Validation, etc.)
- Aid in the development and execution of Manufacturing process verifications and validations.
- Participates in cross-functional team to develop risk management files (plans, assessment and reports).
- Reviews new and modified product design for quality characteristics and develops the quality inspection plans.
- Provide Quality support to facilitate resolution of product nonconformities.
- Leads and/or participates in company-wide Corrective and Preventive Actions projects.
- Assist in the inspection, investigation and documentation of product customer complaints.
- Responsible for product and process change review and approval.
- Direct or assist inspection training for QC inspectors and QE technicians.
- Assist and support other team members as necessary.
- Know and apply the Quality System and any appropriate Federal and International standards.
- Assist and support other team members as necessary.
Education:
- Bachelor’s Degree from an accredited institution required.
- Minimum 3 years experience in the medical device industry
- Experience in GD&T and use of inspection equipment
- Quality System knowledge required
- ASQ CQE Certification desirable
- Understanding of statistical analysis and sampling plans
- Expertise in Microsoft Office products
- Ability to work effectively in a team environment