Quality Engineer

Location: Scottsville

At Cooper Vision, a division of Cooper Companies, we're driven by a unifying purpose to help people to experience life's beautiful moments. We are connected through our shared values - dedicated, innovative, friendly, partners, and do the right thing. As a leading global manufacturer of contact lenses, we are committed to helping improve the way people see each day. Through our diverse lens portfolio, we tackle the toughest vision challenges - including astigmatism, presbyopia, and childhood myopia.

We offer the most complete collection of spherical, toric, and multifocal products available, enabling us to fit 99% of all contact wearers. Learn more at

Job Summary:

Uses Quality Engineering principles - Six Sigma Lean-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. Reviews, develops and maintains all associated documentation. Assists in process and product improvement projects and provides technical input and assistance. Leads quality initiatives in business units.

* Leads, supports, consults, and trains quality improvement projects throughout the life cycle of Cooper Vision products, including process design and development, manufacturing, and purchasing.

* Utilizes quality Engineering / Six Sigma tools and techniques to establish sampling plans, develops quality plans, conducts and participates in FMEA activities, support reliability engineering activities, conduct process and systems audits and to assist in specification development. Facilitate risk assessment using FMEA and take part in change management systems.

* Analyzes routine and test data for improvement opportunities. Participates in the designs experiments (DOE's) for process and product improvement and validation testing.

* Leads statistical analysis for sampling plan rationale and analysis, including but not limited to, DOEs, Paretos, ANOVA, and SPC applications.

* Evaluates manufacturing quality performance capability and develop criteria to monitor and

improve existing processes.

* Investigates instances of nonconforming material and facilitates the determination of root cause and corrective action/preventive action. Lead teams responsible for the improvement activities

* Develop/execute validation plans.

* Participate in business unit to develop personal and departmental performance objectives. Reporting monthly on progress made against those goals.

* Proficient in knowledge of the quality System Regulation (21 CFR PART 820, including 21

CFR
806) and ISO 13485 requirements.

* Partners with Global QE team to deliver executive and/or client workshops and training as required.

* Provides process mapping and modeling, and provides guidance/options.

Travel Requirements:

This position may require local or global travel as needed, less than 5%.

Knowledge, Skills and Abilities:

* Should have extensive knowledge of business process management, scorecards and dashboards, improvement methodologies, project management, matrix program leadership and ROI (return on investment) measurement.

* 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 and the general public.

* To be successful in this role the individual must be able to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.

* The candidate will be able to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Must possess the ability to interpret a variety of instructions furnished in written, oral or diagram format.

* Establishes OEE and SPC requirements as needed.

Work Environment:

* The employee is frequently exposed to moderate…