QC Inspector

Job Description

POSITION SUMMARY

We're seeking a detail-oriented Quality Control (QC) Inspector to join our dedicated team, working within our 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 manufacturing 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.
• Perform post-processing monitoring to ensure conformance to quality standards.
• Work in tandem with the Manufacturing management team and manufacturing associates ensuring seamless operations and effective communication.
• Diligently follow all documented policies and procedures including the company’s Compliance Program, FDA regulations and guidance, work schedules, breaks, and general attendance policies.
• Provide feedback and suggestions on potential areas of improvement within manufacturing and QC processes.

Qualifications

EDUCATION & EXPERIENCE:

• H.S. Diploma or equivalent required.
• 1-3 years QC Inspection experience required, preferably within the medical device sector.
• Experience with dimensional measurement equipment such as micrometers, calipers, gage pins, dial indicators, etc.; precision measuring equipment such as CMM, Vision Systems, etc. preferred
• Ability to interpret engineering drawings and specifications and GD&T per ANSY Y14.5 preferred
• Familiarity with 21 CFR 820/ISO13485, or other government/ISO standards preferred
• Knowledge of machined and/or 3D-printed components is a plus

Additional Information

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

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