Apply on Employer Site

Treace Medical Concepts, Inc. · 1 day ago

Senior Quality Control (QC) Inspector

Ponte Vedra Beach, FL

Full-time

Onsite

Senior Level

5+ years exp

Treace Medical Concepts, Inc. is revolutionizing 3D solutions for the treatment of complex bunion deformities. They are seeking a Senior Quality Control (QC) Inspector to ensure compliance with Good Manufacturing Practices (cGMP) and maintain the quality and safety of their additive manufacturing operations in a cleanroom environment.

Health CareMedicalMedical Device

Growth Opportunities

Responsibilities

Performing inspections of work-in-progress, finished parts, assemblies, and kits, as well as completing all necessary paperwork for product release

Assembling non-sterile products into kits for final release to the field

Conducting visual and dimensional inspections to ensure compliance with quality specifications

Reviewing device history records to confirm accuracy and completeness

Identifying and documenting product nonconformances, collaborating with Operations for resolution

Participating in the development of future inspection procedures

Setting up, calibrating, and maintaining inspection equipment

Monitoring and maintaining the Class 8 cleanroom environment to ensure alignment with stringent quality and cGMP standards

Adhering to and promoting safety protocols while actively contributing to process improvement efforts

Following aseptic techniques consistently to maintain the integrity of the cleanroom

Collaborating with the Clean Room Team Lead and other team members to ensure seamless communication and operations

Assisting with scheduled cleanroom facility cleaning to uphold a contaminant-free environment

Providing feedback and suggestions for improving QC and manufacturing processes

Qualification

QC Inspection experienceCleanroom environment experienceDimensional measurement equipmentEngineering drawings interpretationISO standardsProcess improvementSafety protocols adherenceProblem solvingAttention to detailCollaboration

Required

H.S. Diploma or equivalent required

5+ years QC Inspection experience required with 1+ years prior clean room environment experience preferred, preferably within the medical device sector

Experience with dimensional measurement equipment such as micrometers, calipers, gage pins, dial indicators, etc

Experience with precision measuring equipment such as CMM, Vision Systems, etc

Ability to interpret engineering drawings and specifications and GD&T per ANSY Y14.5

Proficient in computer word processing and Microsoft Office applications