Sr. Manufacturing Process Engineer, Quality Operations, Medical Device (Irvine, CA)

SNAPSHOT!

Looking for a chance to join a world-class ophthalmic medical device company in Orange County experiencing explosive growth? In this fast-track, permanent role, you’ll be responsible for the quality oversight of the execution, validation, and monitoring of activities required for the manufacture of our client’s products! This includes the activities that occur at the company as well as critical company suppliers, including company sterilization vendors. Our client offers an excellent comprehensive benefits package that includes health insurance, paid holidays, paid vacation and sick leave, and a 401(k) plan!

Immediate Opening for a Sr. Manufacturing Process Engineer in Irvine, CA who possesses:

• Bachelor’s degree or equivalent in an engineering field, in either physical or life sciences

• 5+ years related experience in the medical device industry with an ISO 13485 certified company

• Must hold certification as ISO 13485 lead auditor

KEY RESPONSIBILITIES INCLUDE:

• Works in conjunction with Manufacturing and R&D to develop and/or improve manufacturing processes and technology for the production of company devices

• With quality oversight, supports and improves present production processes to manufacture reliable products at a reasonable cost

• As the quality representative, assists with the transfer of new products into production from a “design for manufacturability” approach

• Working with Manufacturing, authors and maintains manufacturing process documentation, as required

• Oversees devices in all stages of production and assists Manufacturing with training, troubleshooting, quality review and efficiency improvement

• Conducts CAPA investigations and corrections/corrective actions to improve the company Quality Management System and resolve noted nonconformances in areas of expertise

• Develops and executes process validations, conducts studies, performs DOE evaluations, as needed, to ensure process capability. Drafts protocols and reports that support these quality driven activities.

• Supports the company Supplier Management process with active participation in the supplier auditing program, evaluations of company suppliers, CAPA follow up with suppliers to resolve nonconformances generated via the NCR system, and maintenance of the company’s Approved Supplier List (ASL).

• May be the key quality representative responsible for the management of the NCR (Nonconformity Report) system.

If you’d like to explore, send your resume to admin@snapstaffing.com and we’ll follow up with you ASAP!