CooperVision, a division of CooperCompanies (NYSE: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

Who We Are

Paragon Vision Sciences, Inc., a Cooper Vision specialty eye care company, is a world leading manufacturer of specialty contact lenses and oxygen permeable contact lens materials. Our CRT® lens (a class three medical device) is considered the lens of choice by many eye care professionals around the world. Paragon’s office is located in Gilbert, Arizona.

Why Work With Us

We are certified as a Great Place to Work®! Our environment recognizes each employee as a vital member of the team. Integrity and respect are fundamental to our working relationships. We are friendly, inventive, and dedicated. We don’t quit until the job is done right! Our lenses don’t just change vision, they change lives. Join a team that is passionate about improving other’s visual health and quality of life.

JOB SUMMARY

Responsible for the quality control activities related to contact lens manufacturing and other processes, maintaining high productivity, exceptional quality and building team moral.  Oversees Quality Inspectors to assure all results and processes comply with specifications.  Reviews, develops, and maintains associated documentation. 

ESSENTIAL FUNCTIONS

• Understand and adhere to specified Standard Operating Procedures (SOP’S), and written work instructions (WI) complying with FDA requirements, GMP and ISO standards. 


• Supervise Quality Inspection Team, provide support, mentoring, training, and performance reviews.


• Familiar with equipment in the QC areas and have ability to help troubleshoot basic problems.


• Able to jump into all types of Paragon QC inspections with little no notice, to help the team meet output or quality goals. 


• Provide open communication and feedback to Quality and Production Management.


• Demonstrate and coach employees to support CooperVision, company goals and objectives, policies, and procedures in compliance with quality manual and quality system processes.


• Maintains a culture of quality awareness, teamwork, and cooperation with all groups within the facility.


• Coordinates calibration of applicable QC Instruments and tools.


• Maintains and approves QC employee timecards.


• Assists Operations and Engineering in the investigation of nonconforming material and assists the teams responsible for the improvement activities.


• As business needs dictate, works extended hours to complete department goals or tasks which may include overtime.


• Other duties as assigned.

PVS management team is committed to the development 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. 

POSITION QUALIFICATIONS

KNOWLEDGE, SKILLS AND ABILITIES

• Advanced Microsoft office tools


• Proactive in problem solving and equipment performance


• Proven experience leading mid-size groups of people (5-15)


• Ability to manage staff and maintain high moral


• A strong understanding of team building and working with people


• Experience with conflict management


• Adaptable, able to creatively brainstorm and work successfully with other departments on issues outside of quality control


• The ability to effectively communicate technical problems to support groups.


• Data analysis and interpretation skills


• Strong understanding of quality systems.  Including practical application of ISO 13485 and FDA Quality System Regulation 21 CFR part 820


• GCP or GMP experience


• Leadership, interpersonal and written communication skills to communicate effectively at all levels within Quality as well as cross functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing

WORK ENVIRONMENT

• Job position requires the ability to stand for 8 or more hours continuously


• Laboratory and Office working environment


• Use of computer systems


• The employee may be intermittently exposed to moderate noise levels

EDUCATION

• High School diploma or equivalent. 


• Associates Degree preferred.

EXPERIENCE

• Minimum of 3 years’ experience in Quality role, also a minimum of 2 years of experience managing others.

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