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 skillsUse of basic Quality measurement equipment and tools such as profile overlays, calipers, hand gages, etc.Basic computer skillsFamiliar with 21 CFR Part 820 and ISO 13485 subclauses on Acceptance CriteriaIntermediate level understanding of GC&T ASME Y14.5Ability to use micrometers, calipers, depth-gauge, height gauge, visual comparator, and vision systemAbout Exactech
Exactech is a global medical device company that develops and markets orthopaedic implant devices, related surgical instruments and the Active Intelligence® platform of smart technologies to hospitals and physicians. Headquartered in Gainesville, Fla., Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Visit www.exac.com for more information and connect with us on LinkedIn , VuMedi , YouTube , Twitter and Instagram .
