Quality Engineer

Regulatory Jobs; Town of Henrietta (NY); On-site; USD 70,000 - 93,000; Full time

Job summary

CooperVision, a division of CooperCompanies, is seeking a Quality Engineer to apply Lean, Six Sigma and root cause analysis to develop and optimize quality systems within medical device distribution and packaging operations.

You will lead FMEA activities, DOE studies and SPC analyses, support internal/external audits, and mentor teams; travel may be required. A BS in engineering and 3+ years of related experience are expected.

Qualifications

• Bachelor’s degree (B.S.) in engineering or related discipline.
• Minimum 3+ years applicable experience in medical device distribution and packaging operations.
• Certified Quality Engineer, Green Belt or Lean certified preferred.
• Working knowledge of Quality System Regulation (21 CFR Part 820) and ISO 13485.
• Experience with DOE, FMEA, SPC and Six Sigma methodologies.

Responsibilities

• Uses Quality Engineering, Lean tools to establish sampling plans and quality plans.
• Investigates nonconformances and drives root cause and corrective actions.
• Analyzes data and conducts DOEs for process and product improvement; develops validation plans.
• Supports audits and delivers quality improvement projects.
• Provides statistical support for sampling, DOEs, Pareto and SPC.

Skills

Project management

Problem solving

Cross-functional teamwork

Data analysis

DOE studies

Six Sigma

CQE / Lean

Reading / writing reports

ISO 13485 knowledge

Excel / Minitab

BAAN / Agile / JDA familiarity

Education

Bachelor of Science in Engineering or related

Certified Quality Engineer / Lean / Green Belt preferred

Tools

Minitab

BAAN

Agile

JDA

Microsoft Excel

Job description

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.

Job Summary:

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.

Travel:

May be required to travel as needed.

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.

Work Environment:

• Normal Office environment.

• Ability to perform light to medium physical work and standing for long periods of time, if required depending on the task.

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.

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.

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 $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.