Quality Engineer - Medical Devices & Process Excellence

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, 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.