CooperVision, a unit of The Cooper Companies, Inc. (NYSE:COO), is one of the world's leading manufacturers of soft contact lenses and related products and services. The Company produces a full array of monthly, two-week and daily disposable contact lenses, all featuring advanced materials and optics. CooperVision has a strong heritage of solving the toughest vision challenges such as astigmatism and presbyopia; 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 TITLE: Quality Engineer
DEPARTMENT: Quality Assurance
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. Oversees process and product validations to assure all processes comply with company specifications to include QSR and ISO requirements. 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 CooperVision 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 21CFR806) 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.
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.
- Microsoft Windows, Microsoft Office,
- Establishes OEE and SPC requirements as needed
- The employee is frequently exposed to moderate noise levels.
- Time spent in the following Physical Activities:
- Stand: Over 75%
- Walk: Over 75%
- Hand/wrist dexterity: Over 50%
- Sit: Over 50%
- Reach: Over 50%
- Stoop, kneel, crouch, crawl: Over 25%
- Climb or balance: Under 25%
- Taste or smell: Under 25%
- Lift up to 25 lbs: Over 25%
- Close, distance, color vision: Over 75%
- Peripheral, depth perception, focus: Over 75%
- Bachelor's degree (B.A.) from four year college or university.
- Certified Quality Engineer, Six Sigma certified Black Belt – Green Belt, Lean/manufacturing knowledge.
- Minimum of 5 plus years applicable experience and/or training or equivalent combination of education and experience with Medical device manufacturing.