Quality Engineer
Quality Engineer
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
CooperVision a division of CooperCompanies (NASDAQ:COO) is one of the worlds leading manufacturers of soft contact lenses. The Company produces a full array of daily disposable twoweek 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.
Job Summary:
Performs and/or coordinates specific tasks and functions within the companys Quality System areas.
Responsibilities
Accountable for:
- 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 multidisciplinary teams engaged on above activities.
- Validation activities such as: Protocols Deviations and Reports
Assists in:
- Review and update SOPs and project related documentation
- Perform eQMS document submission (DCR DCO ECO QP APP etc.
- Assist in developing and of Engineering Studies
Actively participates in:
- Design control design transfer meeting
- Meeting related to projects activities as Risk Assessment Quality Plan and Project meetings.
CooperVisions management team is committed to the development of 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 andregulatory requirements.
Qualifications
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 selfstarter 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:
- Bachelors degree in engineering Science or related field
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.
For U.S. locations that require disclosure of compensation the starting base pay for this role is between $68900.00 and $ 91867.00 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.
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Employment Type
Full-Time
