Job Description

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

Scope:

Responsibilities are West Henrietta site specific with frequent collaboration with other CooperVision sites and outside vendors.

Responsible for managing department budget including current costs and future budget recommendations.

Job Summary:

Responsible for managing Quality Engineers and Quality Technicians to deliver process and quality improvements and resolve quality issues for CooperVision’s packaging and distribution facility at West Henrietta. Additionally, responsible for leading CAPA and Risk Management activities for the site as well as overseeing process validations to ensure they are effective and compliant with the quality system and regulations. The position reports to Sr. Quality Assurance Manager.

Responsibilities

Essential Functions & Accountabilities:

• Lead the quality engineering function by applying and championing effective and efficient problem solving and statistical tools to drive a culture of continuous improvement utilizing such tool and methodologies as Lean, DMAIC, Six Sigma, Cause and Effect Diagrams, Control Charts, Histogram, Pareto, FMEA, DOEs etc.
• Provide leadership and development for exempt and non-exempt staff of Quality Engineers and Quality Engineering Technicians including assessing organizational capabilities and leading the development strategy, raising capacity and competency to support the continued growth of the organization.
• Define, prioritize and implement improvement projects aligned with Key Performance Indicators, OEE improvement and long-term business objectives of the Scottsville Site and Business Units.
• Support capacity expansion projects including review of requirements, technical reviews, FAT and IQ/OQ/PQ as well as ownership of the Quality Plans and Risk Management activities.
• Manage CAPA Program, ensuring effective development, deployment, maintenance, and improvement of the Corrective Action and Preventative Action (CAPA) Management process within the site. Requires interaction and coordination with global quality representatives to ensure alignment on this global system.
• Manage the Risk Management Activities for the site including FMEA
• Partner with other functions and management team to continuously drive improvements in the effectiveness of the systems and processes to ensure efficiency, compliance with the quality system and external regulations and improvement in the customers experience.
• Champion and maintain a safe work environment including equipment, training and a high level of safety awareness among personnel.
• Performs other duties as assigned.
  
  
  

Travel:

Travel may be required (5 to 10%).

Qualifications

Knowledge, Skills and Abilities:

• Demonstrated success leading continuous improvement in a cross functional Business Unit structure including application of structured problem-solving using quality engineering tools and strategies
• Experience managing CAPA and Risk Management process for a site
• Understands manufacturing metrics as they align to Process Improvement initiatives
• Proven experience defining strategy and developing technical capabilities of a department by leveraging internal and external resources
• Fundamental knowledge in Lean Manufacturing , Six Sigma, Quick Changeover, Error Proofing
• Knowledge in root cause investigation, change control management , PFMEA, error proofing, statistical process control
• Ability to define project objectives, create and execute project plans
• Experience working within a regulated industry required, medical device experience strongly preferred
• Ability to effectively present information and respond to questions from Leadership, customers and government regulatory officials
• Intermediate skill in the use of Excel, Word and PowerPoint. Advanced preferred
  
  
  

Work Environment:

• Will often work near moving mechanical parts
• There may be extended periods of sitting and using a computer.
  
  
  

Experience:

• Minimum 5 years’ experience managing quality engineers and/or technicians in a manufacturing, packaging, or related environment
• Minimum of 7-10 years’ experience with progressive assignments in quality engineering, process development, Lean and Six Sigma initiatives, and continuous improvement in manufacturing, packaging, or related environment
• Leadership role within Quality Assurance structure a plus.
• Experience in medical device manufacturing environments a plus.
  
  
  

Experience in software validation a plus.

Education:

• B.S. in Mechanical Engineering or closely related engineering discipline preferred
• Certified Quality Engineer Preferred
• Lean Six Sigma certification preferred.
  
  
  

For U.S. locations that require disclosure of compensation, the starting base pay for this role is between $101,536.00 and $145,051.00 per year and may include cost of living adjustments. The actual base pay includes many factors and is subject to change and modification in the future. This position may also be eligible for other types of compensation and benefits.

We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace.

About Us

CooperVision is a global leader in the contact lens industry, dedicated to helping improve the way people see every day. Achieving that goal takes the collaboration of team members with wide-ranging skills; from scientists and researchers, to manufacturing and operations experts, to sales and marketing professionals.

At CooperVision, our effort to improve lives begins with our employees. We are committed to developing people as a key global differentiator and our most important asset. We empower employees to succeed, rewarding great thinking and hard work with competitive pay, comprehensive benefits, and with a special focus on wellness. Our commitment to our core values and an employee-centric culture fuel a deeply engaged, high performing organization.

CooperVision employees pride themselves on being proactive, innovative, flexible and friendly. That's a strong reflection of our corporate culture—and part of the reason CooperVision may be a great workplace for you.