Quality Engineer II

Quality Engineer II provides quality engineering support for post-market and sustaining engineering activities on released medical devices in the Electrosurgery and OR Safety portfolio. The role ensures design changes, product improvements, and issue resolution comply with quality management systems, design controls, and risk management standards while partnering with cross-functional teams.

Responsibilities

• Develop, modify, and maintain quality standards and protocols for product materials and processing
• Devise and implement inspection, testing, and evaluation methods for product precision and accuracy
• Design inspection and testing equipment specifications; conduct quality assurance tests and statistical analysis
• Collaborate with engineering, manufacturing, and regulatory teams to assess product changes and support documentation
• Ensure corrective measures meet reliability standards and documentation is compliant with requirements

Requirements

• Bachelor's degree in relevant field or Master's degree
• Minimum 2 years of relevant quality engineering experience
• Knowledge of design control and quality management systems
• Statistical analysis and quality assurance testing expertise
• Cross-functional collaboration and problem-solving skills
• Medical device industry experience preferred