• 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.

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.