Quality Engineer, Rack Infrastructure – Site Operations
OpenAI
PMP
Design Quality Engineer
Exactech
full-time
Posted on:
Location: Florida • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Provide support to new product development projects and serve as a subject matter expert on product lifecycle management requirements and processes.
- Ensure product development projects and product changes comply with FDA Quality System Regulation Design Phases and Exactech Quality Management System.
- Participate in cross-functional teams to review and develop product requirements supporting marketing needs through the product life cycle.
- Aid transfer of design requirements to manufacturing (Exactech Manufacturing or suppliers) as part of New Product Development.
- Aid insourcing of new and previously released products to Exactech Manufacturing.
- Aid transfer of design requirements for additional suppliers for previously released products.
- Aid development and release of Design Control Documentation (Design Transfer Matrices, Design Verification & Validation, etc.).
- Aid development and execution of manufacturing process verifications and validations.
- Participate in cross-functional teams to develop risk management files (plans, assessments, and reports).
- Review new and modified product designs for quality characteristics and develop quality inspection plans.
- Provide quality support to facilitate resolution of product nonconformities.
- Lead and/or participate in company-wide Corrective and Preventive Actions projects.
- Assist in 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.
- Know and apply the Quality System and any appropriate Federal and International standards.
- Assist and support other team members as necessary.
Requirements
- 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
