Senior Quality Engineer

About the role

Quality engineering activities across medical device product development, design controls, manufacturing technical transfers, and sustaining operations.

Tasks

• Develop, review, and approve quality plans, product specifications, engineering changes, and product development deliverables.
• Lead and maintain design control activities in accordance with #FDA and #ISO regulatory requirements.
• Review and approve Design Verification and Validation (#V&V) protocols, reports, and related documentation.
• Support equipment and manufacturing process validation activities, including #IQ, #OQ, and #PQ.

Requirements

• Minimum 8+ years of Quality Engineering experience in the medical device industry.
• Strong experience supporting Class II and Class III medical device development and manufacturing.
• Hands-on experience with design controls, risk management, and product development quality activities.
• Knowledge of #FDA and #ISO regulatory requirements.
• Preferred: Master's degree in Engineering, Biomedical Engineering, or a related field.

How to apply

• Connect with us or send your resume by email.
• Apply through the link.

Location

• Cincinnati, OH