Job Description

Job Description

Responsibilities

• Participate on cross-functional new product development teams with focus on the execution of quality plans and design transfer.
• Perform quality audits and/or inspections.
• Develop and implement statistically valid sampling plans, design of experiments, capability studies, SPC and trend analysis.
• Lead and/or participate in process and product corrective actions and problem-solving activities.
• Constantly review the current quality system and recommend / implement improvements as needed.
• Review collected data to perform statistical analysis.
• Participate on projects focused on quality system, product quality and service quality improvement.
• Collect data and prepare reports on the trends of the quality system key performance metrics.
• Participate/support external and internal quality system audits.

Qualifications

Requirements

• Bachelor's Degree in Engineering or related technical field required.
• 8+ years of combined Quality, Process, Manufacturing, Project, Design, Development and/or Test Engineering experience with the desire to focus on Quality Engineering as a career interest.
• Experience and understanding of working with various Quality Management Systems.
• Experience in a manufacturing setting; preferably in a regulated environment…Medical Device would be ideal.
• Experience working in an ISO certified environment is required; ISO 13485:2016 is preferred.
• Experience with EO sterilization validation is a plus. 
• Experience with root cause analysis tools.
• Experience working on cross-functional teams and on own initiative.

Additional Information

All your information will be kept confidential according to EEO guidelines.

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