QC Technician II

7 days ago

Gainesville, United States Exactech Full time

Department: Quality

Location: Gainesville, FL

Description

To ensure all products meet Exactech specifications prior to final acceptance. This includes review and completion of applicable documentation. Additionally, these tasks shall be accomplished in compliance with FDA and ISO Standards as delineated by the Quality Management System.

Key Responsibilities


  • Perform and document inspection requirements following approved SOPs and WIs for incoming and finished products including implants, instrumentation, raw material, and trays.
    • Document and notify QC Supervisor / Manager of non-conformances (NC).


  • Create NC record, segregate NC product, and completion of NC system tasks as assigned by QC Supervisor/Manager.
  • Assist with Material Review Board process and execute NC dispositions.
  • Perform product inspection in accordance to established Sampling Plans.
  • Maintain ERP system status and location of product to ensure accurate identification and traceability.
  • Perform Stock Audits as assigned by QC Supervisor / Manager.
  • As needed - Perform Environmental Monitoring tasks.
  • Perform First Article Inspection (FAI) and/or Special Inspections (SI) per established procedures.
  • Know and apply the Quality System and any appropriate Federal and International standards.
  • Assist and support other employees, teams, and sales personnel as necessary.
  • Conduct Training of team members as assigned by QC Supervisor / Manager.
    o Show ability to use and train peers on the use of micrometers, calipers, depth-gauge, height gauge, visual comparator, profilometer, and air-gauge.
  • Perform Sterile Lot reconciliation and release per established procedures.
  • Assume an active role in resolving QC Holds (or MES Events) with QAE support.

Skills, Knowledge and Experience

Education:
  • High School Diploma or GED required.
Experience:

  • Minimum of 3 years QC inspection experience in the medical device industry with close tolerances preferred or equivalent industry experience.
  • Minimum of 3 years' experience demonstrating proficiency in Geometric Dimensioning and Tolerancing (GD&T).

Functional/Technical Knowledge, Skills and Abilities Required:

  • Attention to detail, accuracy, and documentation skills
  • Use of basic Quality measurement equipment and tools such as profile overlays, calipers, hand gages, etc.
  • Basic computer skills
  • Familiar with 21 CFR Part 820 and ISO 13485 subclauses on Acceptance Criteria
  • Intermediate level understanding of GC&T ASME Y14.5
  • Ability to use micrometers, calipers, depth-gauge, height gauge, visual comparator, and vision system

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