Quality Engineer

We are seeking an intelligent individual to fill the role of Quality Engineer, based in Warsaw, IN. The successful individual will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle.

Responsibilities

• Conduct benchmarking and network to develop more effective methods for improving quality
• Support development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.

• Review/analyze whether current product and processes comply with relevant standards.
• Conduct periodic line audits to assess for production controls.
• Partner with relevant departments to ensure proper application of design controls, risk management and the investigation/correction of design failures/challenges.
• Supports new product introduction as part of design transfer.
• Supports activities related to the Material Review Board.
• Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
• Analyze/review effectiveness of preventive and corrective actions.
• Develop, interpret and implement appropriate process monitoring and control methods.
• Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
• Develop, interpret and implement standard and non-standard sampling plans.
• Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
• Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits.
• Document, justify, review and analyze risk.

Skills And Qualifications

• BA in related field and 2-4 years relevant experience.
• Experience working in both an FDA and European regulatory environment preferred.
• This position will require relevant experience working in manufacturing/operations.
• In-depth knowledge of product/process risk management required.
• Experience with a proven track record of implementing appropriate risk mitigation.
• Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred including Measurement System Analysis, SPC, DOEs, Reliability, etc.
• Strong knowledge of Microsoft Office suite and statistical software packages.
• A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
• Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.