Senior Quality Engineer

Position Summary

The Quality Engineer ensures products and assemblies meet specifications and all applicable product quality, design and manufacturing process requirements. Provide leadership in areas of product quality assurance and quality engineering to drive business objectives, continuous process and product improvements. Develop and maintain procedures to ensure that statistical control is maintained in the critical processes.

Essential Job Duties and Responsibilities

• Work closely with Manufacturing, Manufacturing Engineering, Development and Technical Support to ensure high quality products and processes are developed and deployed. The activities include product design verification, process validation, risk assessment, and FMEA.
• Apply structured problem-solving methods (5Why, Ishikawa diagrams, DMAIC, Six Sigma, Statistical Process Control, Design of Experiment).
• Support complaint investigations and work with appropriate parties in providing corrective and preventative actions based on sound engineering analysis.
• Monitor and report on necessary Quality metrics to ensure high product quality and process improvement opportunities are identified.
• Review and ensure all process, material and procedural changes are engineering sound and in compliance to all FDA, QMS, and ISO Quality Procedures.
• Provide statistical support and expertise and analytical problem solving for product development and manufacturing.
• Supplier Management including auditing and Supplier Corrective Action Requests.
• Implements quality training programs to key personnel in conjunction with manager including Quality integration of our business framework.
• Identifies areas requiring quality improvement and initiates cross-department projects and investigations targeting correction and prevention of issues in support of business objectives including product safety and performance, COPQ reduction, and system upgrades and follows through plans of action.
• Drive 6S update projects related to Quality and Quality processes.
• CMM/OGP programming, FAIR Measurements, custom gage creation for developing products/projects
• Support QMS SOP development for effective, efficient compliance and in support of high-quality product
• Participate in internal quality audits.
• Provides detailed and data driven input based on observations, experience, and feedback in support of business objectives.
• All other duties as assigned.

Knowledge/Skills/Abilities

• Certified Quality Engineer or Reliability Engineer.
• Certified Six Sigma Black Belt.
• Effective leadership and interpersonal skills, strong decision-making skills.
• Strong analytical skills.
• Ability to work proactively and independently.
• Working knowledge of Injection Molding equipment and processes.
• Working knowledge of machined part equipment and processes.
• Working knowledge of part inspection techniques.
• CMM programing.

Education and Experience Requirements

• A Bachelor's degree in Engineering or similar required
• 6 - 9 years' experience in a regulated and fast-paced medical device manufacturing area.
• Hands-on experience in statistical analysis.
• Proficient in Microsoft Office products.
• Experience working in ISO13485 manufacturing environment or equivalent.
• Good written and verbal communication skills.
• Must be able to demonstrate basic problem-solving skills-Root Cause Analysis/Problem Solving Methods.
• Must be able to follow all safety policies and guidelines and work in a safe manner.