Qualifications

• Bachelor's degree in Mechanical Engineering, Industrial Engineering, or a related technical discipline.
• 3-5+ years of Quality Engineering experience in a regulated industry, preferably in medical devices.
• Proven track record supporting the introduction of new products and processes within medical device manufacturing.
• In-depth knowledge of product verification and validation processes.
• Familiarity with FDA requirements and ISO 13485 quality standards.
• Proficient in applying statistical and risk-management techniques in a manufacturing context.
• Strong skills in root cause analysis and corrective action management.

Responsibilities

• Lead Quality Engineering efforts on cross-functional teams for new product and technology introductions.
• Create and maintain validation protocols for products and processes.
• Conduct revalidation activities following engineering changes or upgrades.
• Utilize statistical analysis for validation activities, establishing inspection methods and criteria.
• Perform risk analyses to mitigate potential issues during development.
• Collaborate with R&D and Engineering to define Critical-to-Quality characteristics.
• Direct Design for Inspection initiatives to enhance product consistency and reduce errors.

Benefits

• Opportunity to work with cutting-edge medical device technologies.
• Engagement in cross-functional team environments for dynamic project experiences.
• Professional growth through new technology and process validation challenges.
• Involvement in compliance initiatives with tightly regulated industry standards.
• Contributions directly impacting patient safety and quality outcomes.