Senior Quality Engineer - TEMP

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:

Holds a role in ensuring the seamless integration of quality assurance processes across the organization. 

Integration Activities:

• Collaborate with cross-functional teams to seamlessly integrate quality assurance processes across various stages of the quality system.
• Facilitate communication and coordination between quality assurance and other departments/sites to foster a culture of quality excellence.

KPI Definition/Establishment:

• Assess, define, and establish Key Performance Indicators (KPIs) to effectively measure the efficiency and effectiveness of quality assurance processes.
• Develop and implement strategies aimed at enhancing KPI performance and driving continuous improvement in quality outcomes.

Trending:

• Establish a robust system to monitor and analyze trends in quality data, encompassing defect rates, customer complaints, and non-conformance incidents.
• Utilize data analysis to identify patterns and potential areas for improvement, enabling proactive measures to address quality concerns.

Validation:

• Define and refine the validation process, ensuring alignment with regulatory requirements and industry best practices.
• Develop comprehensive validation protocols, execute testing, and meticulously document results in accordance with established procedures, if necessary.

Change Control:

• Evaluate and refine the change control system, meticulously assessing potential impacts on product quality and regulatory compliance.
• Implement necessary modifications to ensure a controlled change management process that minimizes risks and maintains quality standards.

Sampling Regimes Assessment:

• Conduct a thorough evaluation of existing sampling regimes, ensuring their suitability and effectiveness in upholding product quality and regulatory compliance.
• Recommend adjustments or enhancements to sampling plans based on meticulous data analysis and comprehensive risk assessment.

Project Support

• Actively participate and assist in the planning of the Validation Strategic development for new Processes (NP) / New Technology (NT)
• Provide the appropriate quality technical support to new product development and improvement projects.
• Responsible of Sampling Plan Preparation, Quality Plan Development, Test procedures Implementation and Statistical Data Analysis.
• Use of quality/statistical tools for troubleshooting and process improvement
• Evaluate process/technology changes potential impact on the business and recommending their incorporation into the current and future product lines.
• Lead quality initiatives and participate in multi-disciplinary teams engaged on above activities.
• Validation activities such as:  Protocols, Execution, Deviations, and Reports   

 

Knowledge, Skills and Abilities

• Knowledge of FDA current GMP/QSR Regulation
• Strong applied knowledge on statistical tools:  DOE, Acceptance Sampling, SPC, etc.
• Supervisory skills
• Good oral and written communication skills in both English and Spanish are a must
• Highly motivated, self-starter, and responsible person
• Teamwork oriented

Work Environment

• Generally works in a closed environment, in office conditions, with normal level of noise and controllable changes of temperature
• Needs to stand, walk and may be seated for a long period of time
• Uses hands to feel, finger or handle and reach
• Works with a personal computer and programs to prepare documents or reports
• Applies communication skills (advanced reading, writing, and technical skills) and mathematical concepts knowledge to perform work and coordinate with others

Experience

• Five years or more of experience in Quality Engineering
• Willing to travel

Education

•  , Science or related field