Supplier Quality Engineer

What You’ll Do

• Support the oversight of suppliers/vendors utilized by Glaukos in the development, manufacturing, and/or distribution of medical devices and pharmaceutical products.
• Perform supplier/vendor assessments, on-site inspections, and monitor vendor/supplier performance in accordance with the Supplier Quality Management program.
• Lead and drive assurance of Supplier Quality performance to ensure suppliers meet all identified regulatory and Glaukos specific requirements impacting component and/or product quality.
• Initiate, support, and lead, as applicable, supplier quality related initiatives with suppliers to improve product quality and on-time delivery of contracted goods/services.
• Work closely with internal cross-functional impacted areas, such as Supply Chain Operations, logistics, research development, internal R&D quality and CMCs as well as all the external vendors.
• Support the Senior Director of Quality Assurance in supporting all the activities associated with supplier quality.

How You’ll Get There

• 2-5 years relevant work experience in a medical device manufacturing work environment in a quality discipline.
• Working understanding of 21CFR 210, 211, Annex 1, 21 CFR Part 820, ISO 13845 and ISO 14971 requirements.
• Strong knowledge of regulations applicable to pharmaceutical and medical device manufacturing.
• Experience in performing Quality System and supplier audits is highly desirable.
• ASQ certifications preferred (CQA, CBA, CQE, CSSBB).
• Strong documentation skills, attention to detail and accuracy.
• Strong written/oral communication skills.
• Ability to work cooperatively and effectively in a team environment.
• Experience in Supplier Management with manufactured products.
• Experience with Quality Management Systems (QMS), Root Cause and Corrective Action.
• Demonstrated teamwork and ability to work in the team environment.
• Four years college required/and or preferred and supplier audit certificate.
• Annual salary range: $73,600 - $92,000, plus bonus and excellent benefits package.