Quality Engineer

Job Purpose

In this role the Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer, and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize Quality Engineering principles and problem-solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes.

This person will support processes in base business.

• Support quality improvement initiatives such as process and product characterizations that lead to continuous / cost improvements.
• Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other improvement tools and programs.
• Conduct benchmarking to develop more effective methods for improving quality.
• Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
• 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.
• Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
• Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
• Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality.
• Develop, interpret, and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
• 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.
• Travel requirements: 25% including international travel.

• Bachelor’s degree (B.S.) in an Engineering, Technical, or Scientific field
• Minimum of 6 years of relevant experience, or advanced degree with minimum of 4 years relevant experience
• Understanding of the NPI (New Product Introduction)/Design Controls process and Process Validation expertise is preferred.
• A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
• Prior experience working in medical device industry preferred.
• CQE or LSSGB certification preferred.
• Project Management skills preferred.
• Commitment to excellence and high standards
• Excellent written and oral communication skills preferred.
• Strong organizational, problem-solving, and analytical skills
• Ability to manage priorities and workflow.
• Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
• Acute attention to detail.
• Demonstrated ability to plan and organize projects.
• Ability to work independently and as a member of various teams.
• Proven ability to manage multiple projects and meet deadlines.
• Ability to develop clear, concise, and timely oral and written reports.
• Accurately complete detailed forms and reports.