Quality Assurance Inspector

Description • Perform Inspection of incoming materials, components, and subassemblies • Complete First Article Inspections upon request. • Perform In-process and finished (sterile and non-sterile, disposable, and durable) product inspection and testing. • Perform DHR reviews for subassemblies and finished goods. • Conduct Product Release activities for all conforming products. • Initiate NCR records for all non-conforming products, components, and subassemblies.

• Quarantine non-conforming product and participate in the investigation process. • Maintain Inspection area equipment calibration and PM • Adhere and promote GMP and GDP principles. • Assist in external/internal audit preparations. Requirements EXPERIENCE/SKILL REQUIREMENTS: • Organizational skills and attention to detail. • Firsthand experience using measuring tools such as but no limited to calipers, micrometers, pin gauges and tensile testers.

• Ability to read and understand drawings. • Experience working with sampling plan. • Understanding of ISO 13485, CFR21-820, ISO 146444-1, 2 and 3. • Able to take direction, ownership, and responsibility for QMS related activities. • Positive and cooperative communication and collaboration with all levels to employees, contractors and vendors. • Strong understanding of quality control standards and testing techniques.

• Electronic Quality System experience. • Proficient with Microsoft Office, Excel, and other electronic systems. • Medical device experience is a plus. • Experience working a cleanroom is a plus. EDUCATIONAL REQUIREMENTS: • High School Diploma, GED, or equivalent with additional training in quality control in medical device industry or similar field.