Manager, Quality Assurance (Project Management)

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

RA/QA Manager oversees all activities reacted to regulatory affairs and quality assurance for the CooperVision SEC Sherbrooke site to ensure compliance with applicable regulations and maintenance of current certificates. It is responsible for advising and consulting with stakeholders about compliance.

This position is the Management Representative for the site.

Job Summary:

Manages and communicates with CVI management concerning all major regulatory affairs and quality system issues related to manufacturing, design control and compliance with applicable regulations. The QA/RA Manager will research, recommend, and implement best practices, and contribute to both the strategic and operational functions for the site.

The RA/QA Manager also shares the responsibilities of the Person Responsible for Regulatory Compliance with RAQA Specialist and is responsible for the clauses of Article 15 (3) of the EU Medical Devices Regulation (MDR) 2017/745.