Quality System Specialist - Contract (Manufacturing)

CooperVision, a division of CooperCompanies (NASDAQ:COO), is one of the world's leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable, two-week and monthly contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism, presbyopia and childhood myopia; and offers the most complete collection of spherical, toric and multifocal products available. Through a combination of innovative products and focused practitioner support, the company brings a refreshing perspective to the marketplace, creating real advantages for customers and wearers. For more information, visit www.coopervision.com.

Job Summary:

Responsible for conducting required Quality Assurance activities with local (Rochester) and global departments. Act as the lead for the maintenance of Packaging and Labeling QMS data and ensuring CooperVision compliance to change control requirements for global processes. Oversight over cross-functional teams which provide input to the related processes. Responsible for working with key business stakeholders through the Product Launch Process and Packaging Configuration approval. Acts as site lead for a variety of problem reports (CAPA/NCR/etc.), ensuring timely movement through the process while safeguarding compliance. Involvement with internal auditing for local CooperVision sites. 

Will revise and at times create Standard Operating Procedures (SOP's), Work Instructions (WI's) and other controlled documents in collaboration with process owners and subject matter experts. Will utilize the electronic Quality Management System (eQMS) to process these documents and obtain approvals as well as review Change Orders and support training.  

Participation with establishing procedures for Global review of change packages as well as engineering changes, engineering studies, and validations when necessary.