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.
Duties and Responsibilities (Key Deliverables):
1. Perform and document inspection requirements following approved SOPs for incoming, in process, OEM and finished products. Document and notify QC Manager of non-conformances.
2. Perform and document inspection requirements following approved SOPs for tissue and tissue related products. Document and notify QC Manager and/or Tissue Bank Director of non-conformances.
3. Responsible for maintaining the security and identity of all tissue related products while under his or her control.
4. Status products according to inspection procedures to ensure that product identification and traceablilty is accurate and prevents product mix-up.
5. Perform inspectional audits per procedure following approved sampling plans.
6. Process product returns through the QA quarantine system and disposition to the appropriate electronic and physical locations. Ensure product complaints are documented according to procedure with clear status for further evaluation as required.
7. Conduct activities according to established work standards to ensure a timely flow of product throughout the inspection process.
8. Perform sterile lot receipt of implant products and document any deviations through the non-conforming materials process.
9. Understand and follow all departmental SOP’s. Document and report any process deviations to team leader.
10. Understand and comply with all department safety policies and procedures.
11. Know the Quality System and any appropriate Federal and International standards
12. Assist and support other team members as necessary.
High School Diploma or GED required.
· Prior work in a Quality department in a regulated industry preferred.
· Experience utilizing Geometric Dimensioning and Tolerancing (GD&T) preferred.
Functional/Technical Knowledge, Skills and Abilities Required:
· Attention to detail, accuracy, and documentation skills.
· Aptitude to learn the use of basic Quality measurement equipment and tools such as profile overlays, calipers, hand gages, etc.
· Basic computer skillsCompany Description
Exactech develops and produces innovative bone and joint restoration products that help surgeons worldwide make patients more mobile.