Design Quality Engineer

Department: Quality

Location: Gainesville, FL

Description

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.
  
  
  
  

Skills Knowledge and Expertise

Education:

• Bachelor’s Degree from an accredited institution required.

Experience:

• Minimum 3 years experience in the medical device industry
• Experience in GD&T and use of inspection equipment
• Quality System knowledge required

Functional/Technical Knowledge, Skills and Abilities 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