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Design Quality Engineer
Design Quality EngineerExactech • Gainesville, FL, US
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Design Quality Engineer

Design Quality Engineer

Exactech • Gainesville, FL, US
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Overview

The Design Quality Engineer provides support to new product development projects and serves as a subject matter expert on the requirements and processes for product lifecycle management.

Department : Quality

Location : Gainesville, FL

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.

Qualifications

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

    • Details

  • Seniority level : Not Applicable
  • Employment type : Full-time
  • Job function : Quality Assurance
  • Industries : Medical Equipment Manufacturing

    • J-18808-Ljbffr

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