Senior Quality Control - Ponte Vedra, Florida, United States
3 days ago
Job description
Company Description
At Treace, we are revolutionizing 3D solutions for the treatment of complex bunion deformities. Our innovative, high-velocity approach enables us to consistently exceed customer expectations, delivering minimally invasive solutions that improve patient outcomes and drive efficiency for healthcare providers. By advancing reproducibility and patient satisfaction, Treace empowers foot and ankle surgeons to achieve better surgical results, reduce healthcare costs, and enhance overall care quality.
If you're seeking an opportunity to grow in your career while working with a dynamic and diverse team dedicated to meaningful innovation, Treace could be your next great career destination. Together, let's create something greater than ourselves.
Job Description
Are you passionate about quality, precision, and patient safety? Do you thrive in a fast-paced environment where attention to detail is critical? Join our dedicated team as a Senior Quality Control (QC) Inspector and play a pivotal role in ensuring the highest standards within our additive manufacturing operations and state-of-the-art Class 8 cleanroom.
This is an exciting opportunity for a detail-oriented individual who is committed to excellence and eager to make a meaningful impact in a rapidly growing organization.
About the Role:
As a Sr. Quality Control Inspector, you will ensure that our operations align with current Good Manufacturing Practices (cGMP), consistently maintaining the quality and safety of our processes and products. Working cross-functionally, you will interact with multiple teams and levels of the business, contributing to continuous improvement and operational success.
The ideal candidate is a problem solver with a passion for quality and patient safety, and someone who thrives in cleanroom environments and highly regulated industries.
Your key responsibilities will include:
- 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.
Qualifications
- 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
- Familiarity with 21 CFR 820/ISO13485, or other government/ISO standards preferred
- Knowledge of machined and/or 3D-printed components is a plus
- Proficient in computer word processing and Microsoft Office applications
Additional Information
All your information will be kept confidential according to EEO guidelines.
Treace's Privacy Policy
It is Treace's policy not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, veteran status or any other characteristic protected by applicable law. EEO/Disabled/Veterans Employer
Treace is a drug free employer.
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