Supervisor, Quality Assurance

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:

The Quality Assurance Supervisor ensures the effective implementation and execution of production quality controls to ensure the distribution of safe and effective product.  They are the subject matter expert in contact lens measurement and are accountable for nonconformance, inspection (production and complaint), and quarantine processes.   They ensure these processes meet Quality Management System & regulatory requirements, CooperVision Global policies and procedures and strive to achieve industry best practices. 

1. Accountable for developing, implementing and maintaining nonconformance, measurement, inspection (production and complaint), and quarantine processes.
2. Accountable for employing quality assurance methodologies in support of Engineering, Manufacturing, and Regulatory functions. 
3. Accountable for facilitating effective problem solving and root cause methodologies to resolve quality problems. 
4. Accountable for ensuring all quality requirements are met for all products being manufactured, packaged and distributed from the Scottsville facility and that product meet FDA / International quality system requirements. 
5. Accountable for the effective development, implementation and maintenance of process monitoring program, including process sampling and auditing to ensure product meets customer requirements.
6. Functions as audit lead for in-scope processes during internal and external audits.
7. Accountable for overall staffing, planning, training, and employee relations to achieve objectives and key performance indicators for in-scope processes
8. Accountable for fostering a work environment that holds team members accountable, empowers team members to innovate within their roles and models CooperVision values.
9. Manages the following staff:  Quality Coordinators and Quality Auditors.
10. Supports the Director RC/QA.
11. Other duties as assigned.

CooperVision’s management team is committed to the development of and implementation of the quality management system and maintaining its effectiveness by communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements.

Knowledge, Skills and Abilities:

• Must have leadership skills to effectively define roles and responsibilities, hold team members accountable, foster an environment that embodies the CooperVision Values and empower their team members to innovate within the scope of their roles.
• Must have strong management skills to plan, lead, delegate and control processes within the scope of this position.  This includes skills in performance management and professional development.
• Must have strong verbal, written and interpersonal communication skills to effectively communicate to both employees and management, including to those where English is not their primary language.
• Must have strong knowledge of interpreting and applying regulatory requirements to create, evaluate and improve business processes for a complex operations environment, experience in ISO 13485 and US FDA regulations is preferred.
• Must be able to apply problem solving tools to manage processes, drive improvement and innovation, and reduce the Cost of Quality.
• Must have strong measurement background to ensure the proper use of measurement techniques; including establishing sampling plans, performing measurement systems analysis, evaluating process variation and capability. 
• Must have strong customer relationship management skills for both internal and external customers to effectively capture the voice of the customer, analyze results and anticipate customer needs.
• Must have training and development skills to develop training plans, assess training needs, effectively create and deliver training materials, evaluate training effectiveness
• Must have strong computer skills working with Microsoft Office Suite, Database software, electronic records systems and Statistical Analysis software.  ERP system experience preferred.