CooperVision · 2 days ago
Quality Engineer
Henrietta, NY
Full-time
Onsite
Mid Level
$70K/yr - $93K/yr
3+ years expCooperVision, a division of CooperCompanies, is a leading manufacturer of soft contact lenses. The Quality Engineer position focuses on utilizing Quality Engineering principles to develop and optimize systems and processes aligned with the company's strategy and quality system.
Health CareManufacturingMedical Device
Responsibilities
Utilizes quality engineering and lean tools and techniques to establish sampling plans, develop quality plans, conduct and participate in FMEA activities, support reliability engineering activities, conduct process and systems audits and to assist in specification development
Investigates instances of nonconformance and facilitates the determination of root cause and corrective action/preventive action including the effectiveness of these actions
Analyzes routine and test data for improvement opportunities. Participates in the design experiments (DOE's) for process and product improvement and validation testing. Develops and executes validation plans
Supports, consults, trains and leads quality improvement projects
Provides statistical support for sampling plan and analysis, DOEs, Pareto, ANOVA, and SPC applications
Gathers and evaluates distribution center and packaging performance capability and develops criteria to monitor and improve existing processes, as measured by appropriate quality KPIs
Develop personal and departmental performance objectives based upon the facility quality objectives, reporting monthly on progress made against those goals
Support internal and external audits as needed
Oversees and participates in process and product validations to ensure all processes comply with company specifications to include internal quality systems and ISO requirements as well as applicable laws and regulations
Reviews, develops and maintains all associated documentation including risk management files and quality records
Partners with Quality Assurance team to provide oversight regarding Quality Systems and processes
Partners with Quality Assurance team to deliver workshops and training as required
Provides process mapping and modeling, and provides guidance/options
Qualification
Required
Demonstrated project management and problem-solving skills
Demonstrated communication, facilitation and leadership skills, with the ability to work cross-functionally in a team environment
Applied technical knowledge of Qualitative and Quantitative data analysis, and statistical tools including DOEs
Must possess the ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or government regulations
Able to write reports, business correspondence, and procedure manuals
Possess the ability to effectively present information and respond to questions from groups of senior managers
Has a working knowledge of Quality System Regulation (21 CFR PART 820, including 21CFR806) and ISO 13485 requirements
Microsoft Windows, Microsoft Excel, Minitab
Minimum of 3 plus years applicable experience and/or training or equivalent combination of education and experience with medical device distribution and packaging operations
Bachelor's degree (B.S.) from four –year college or university in engineering or related discipline; equivalent combination of education and experience may be considered
Preferred
Six Sigma GB/BB or CQE preferred
BAAN, Agile, JDA familiarity a plus
Certified Quality Engineer, Green Belt or Lean certified preferred
Company
CooperVision
CooperVision is one of the world’s leading manufacturers of soft contact lenses and related products and services. It is a sub-organization of The Cooper Companies.
5001-10000 employees
H1B Sponsorship
CooperVision has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (12)
2023 (14)
2022 (7)
2021 (13)
2020 (11)
Funding
Current Stage
Late StageLeadership Team
Michael Good
Divisional Chief Financial Officer
Recent News
2026-01-06
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2025-09-28
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