New · posted Oct 15
The Cooper Companies · Medical Devices
Quality Engineer
- Henrietta, NY
- On-site
- Contract
- Senior & Principal
Open until filled
The role
This position uses Quality Engineering principles (i.e. Lean, Six Sigma, Advance Problem Solving, and Root Cause Analysis tools and techniques) to develop and optimize systems and processes so that they are aligned with the overall Company strategy and quality system.
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.
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.
What you need
Education
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.
Certified Quality Engineer, Green Belt or Lean certified preferred.
Knowledge, Skills and Abilities
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. Six Sigma GB/BB or CQE preferred.
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.
BAAN, Agile, JDA familiarity a plus.
Experience
Minimum of 3 plus years applicable experience and/or training or equivalent combination of education and experience with medical device distribution and packaging operations.
Pay
$69,584 – $92,779 a year
Employer providedFor U.S. locations that require disclosure of compensation, the starting base pay for this role is between $69,584.00 and $92,779.00 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.
Where you'll work
Henrietta, NYOn-siteOpen in Maps (opens in a new tab)
More jobs in Henrietta, NYWorking conditions
Travel
May be required to travel as needed.
Normal Office environment.
Ability to perform light to medium physical work and standing for long periods of time, if required depending on the task.
Equal opportunity, accessibility and legal noticesThe Cooper Companies's statements, word for word
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.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 34% below the US median for Quality Assurance roles at this level.
This roleEmployer provided
Senior & Principal roles in New York14 roles publishing pay
Senior & Principal roles in the US284 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $69,584 | — | $92,779 |
| New York (middle half) | $68,000 | $84,750 | $114,875 |
| All US (middle half) | $103,375 | $122,750 | $137,500 |
This role: The Cooper Companies's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not The Cooper Companies's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance5
- Quality systems and risk5
- Collaboration and leadership5
- Documentation and SOPs2
- Investigations and CAPA2
- Validation and qualification2
- Lab testing and methods1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
The Cooper Companies on Regulatory Jobs
- 10
- Open roles
- 10
- Distinct roles
- 5
- Locations
By discipline
- Quality9 90%
- Regulatory1 10%
By level
- Senior & Principal8 80%
- VP & Executive1 10%
- Manager1 10%
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Quality Engineer at The Cooper Companies
Open until filled. $70K–$93K a year, employer provided.