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CooperVision Careers

Global Quality Engineering Manager

Location: CA-Pleasanton/East Bay
Job Code: 2559
# of Vacancies: 1

Description

Seeing things in a different light is just the beginning at CooperVision. Our visionaries put ideas into action, raise the bar on product excellence and create the next generation of contact lenses. And now, so can you....Join our team and become a part of a world class organization that is the second largest contact lens manufacturer in the United States and the third largest in the world. A global powerhouse, we tout a network of facilities that expands our reach to 70 countries.

We offer some of the most respected brands and most advanced lenses in the industry, including our recently launched silicone hydrogels Biofinity® & Avaira® which offer the best vision possible in a soft contact lens. Our Proclear Compatibles® lenses deliver unmatched all day comfort. And our Frequency® 55 Multifocal lenses use a revolutionary two-lens system to help correct presbyopia.

Realize your vision...

JOB TITLE:          Manager, Global Quality Engineering 

DEPARTMENT:    Global Quality Engineering 

JOB SUMMARY

Lead the development & management of a world-class progressive Quality System Program and ensure product and process continuous improvement in a pro-active QSR/GMP and ISO 13485 Compliance for multinational Medical Device manufacturer in an environment that embraces teamwork, change, risk-based decision making and flexibility.

ESSENTIAL FUNCTIONS

  • Lead decision making on Global Quality System strategies
    • Compliance driven global operating procedures and policies
    • Determine areas for harmonization and alignment
  • Evaluate global quality KPI's:
    • identify and lead/support implementation of ideas for improving existing products and processes
    • Communicate with other functional groups on product quality and improvement activities
  • Lead a structured a product benchmark/surveillance program to monitor our products on a regular basis
  • Work in conjunction with Sites QA/QE to coordinate and support quality assurance activities associated with product quality continuous improvement, as part of the CAPA process
  • Create, review and approve Global Quality System Documents (e.g. CAPA, Risk Management and Change Control)
  • Develop and implement strategic quality plans, risk management plan, validation protocols, inspection plans and quality/regulatory compliance operating procedures to meet FDA (Food and Drug Administration) and ISO (International Organization of Standardization) requirements
  • Support the development of the inspection methodology and acceptance criteria for sampling plans, including the incoming, in-process, final, and validation sampling plans as part of the quality planning process
  • Support improving test evaluation/investigation capabilities by developing/transferring test methods
    • Provide technical expertise
    • Compliant with FDA, ISO or other international standards
  • Review and approve change notices involving product configuration and introductions of new product configurations
  • Support company goals and objectives, policies and procedures in compliance with quality policy
  • Represent the Corporation, Division and Quality Department in a professional manner

POSITION QUALIFICATIONS
 

KNOWLEDGE, SKILLS AND ABILITIES

  • Knowledge of: Word processing, Spreadsheets, Internet software, E-mail, Manufacturing software, Database software and Statistical Analysis software
  • Self starter and able to work both independently and as a member of an integrated, interdisciplinary team in carrying out assigned responsibilities
  • Excellent 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

  • Typical office work environment

EDUCATION

  • Bachelor in an engineering or science discipline

EXPERIENCE

  • Minimum 10 years related experience, at least 3 in a management position, in the medical device field and/or training or equivalent combination of education and experience
  • Experience related to design control is a must
  • Applied technical knowledge of Qualitative and Quantitative data analysis, and statistical tools. Six Sigma GB or CQE preferred

 



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