Quality Control Technician

Exactech, Inc.
Job Description

Job Details

Description

Duties and Responsibilities (Key Deliverables):

1. 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).

2. Perform product inspection in accordance to established Sampling Plans per SOP 701-103-129.

3. Maintain ERP system (QAD) status and location of product to ensure accurate identification and traceability.

4. Perform Stock Audits as assigned by QC Supervisor / Manager.

5. Perform all duties as assigned by QC Supervisor / Manager.

6. As needed - Perform Environmental Monitoring tasks.

7. Maintain and disseminate a positive work atmosphere based on Exactech Values and goals.

8. Perform First Article Inspection (FAI) and/or Special Inspections (SI) per established procedures.

9. Create NC record, segregate NC product, and completion of NC systemic tasks as assigned by QC Supervisor/Manager.

10. Assist with Material Review Board process and execute NC dispositions.

11. Know and apply the Quality System and any appropriate Federal and International standards. 

12. Assist and support other employees, teams, and sales personnel as necessary.

Job Requirements:

Education:
High School Diploma or GED required.

Experience:
• 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 skills 

• Familiar with 21 CFR Part 820 and ISO-13485 subclauses on Acceptance Criteria.

• Entry level understanding of GD&T ASME Y14.5.

• Ability to use Micrometers, Calipers, Depth-gauge, Height gauge, Visual Comparator, and Vision-System.

Qualifications

Education

Required

High School or better.

 

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Contact Information