Quality Control Inspector

Treace Medical Concepts, Inc. • Full-time • Ponte Vedra Beach, FL, US • 1m ago

Treace’s mission is to be the leader in the surgical treatment of bunions by establishing the Lapiplasty® System as the standard of care. We are committed to operating our business with the highest standards of ethical conduct. We intend to exceed our customers’ expectations through an innovation-driven, high-velocity approach to solving treatment and surgical problems. With our products and services, our mission is to assist foot and ankle surgeons in improving patient outcomes and reducing healthcare costs, while providing rewarding experiences and opportunities for our employees and stakeholders.

Job Description

POSITION SUMMARY

This position is on site working the hours of 6 am - 3 pm*

We're seeking a detail-oriented Quality Control (QC) Inspector to join our dedicated team, working within our in our state-of-the-art Class 8 cleanroom and additive manufacturing operation. The successful candidate will be integral in ensuring that all operations within these areas adhere to our rigorous standards, as defined by current Good Manufacturing Practices (cGMP) This role demands precision, a strong commitment to quality, and a keen understanding of the vital processes and procedures associated with cleanroom environments. A passion for patient safety and value are critical for success.

The candidate must possess the ability to work cross-functionally to support rapid growth and continuous improvement. This position will interact with many functions and levels of the business.

PRIMARY DUTIES & RESPONSIBILITIES:

Inspection of work-in-progress, finished parts and assemblies, kits and completion of associated paperwork for final release of product
Assemble non-sterile product into kits for final release into the field
Visually and dimensionally inspect products to ensure that they meet quality specifications.
Participate in the establishment of future inspection procedures.
Review device history records to ensure that they are complete and accurate.
Identify and author any product nonconformances, working closely with Operations to resolve.
Participate in the setup, calibration, and maintenance of inspection equipment.
Engage in various cleanroom operations, ensuring all activities align with our established standards and cGMP protocols.
Adhere to safety protocols and contribute to the continuous enhancement of product quality through meticulous attention to detail.
Monitor the cleanroom environment to ensure conformance to quality standards.
Maintain the integrity of the cleanroom environment by consistently following aseptic techniques in all processes.
Work in tandem with the Clean Room Team Lead, other cleanroom associates, and manufacturing associates ensuring seamless operations and effective communication.
Assist in regular facility cleaning schedules, ensuring the environment remains contaminant-free.

Qualifications

EDUCATION & EXPERIENCE:

H.S. Diploma or equivalent required.
3+ 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. preferred
Knowledge and experience with precision measuring equipment such as CMM, Vision Systems, etc. is preferred
Ability to interpret engineering drawings and specifications and GD&T per ANSY Y14.5 is preferred
Familiarity with 21 CFR 820/ISO13485, or other government/ISO standards preferred
Knowledge of machined and/or 3D-printed components is preferred

Additional Information

All your information will be kept confidential according to EEO guidelines.

Treace's Privacy Policy

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Treace is a drug free employer.