Job Description

Quality Engineer – Medical Device Manufacturing $110k - $130k

US Citizens or Green card Holders

Our client is seeking an experienced Quality Engineer to join their team and support Manufacturing Engineering and Production Sustaining efforts within a fast-paced medical device environment. In this collaborative role, you'll work closely with Operations, R&D, and other departments to ensure full compliance with the Quality Management System (QMS).

Are you an experienced Quality Engineer who thrives in Operations, particularly in Design Transfer, daily manufacturing challenges, yield improvement, and scale-up projects? We want to hear from you!

Key Responsibilities:

• Oversee quality system implementation within manufacturing processes.
• Provide Design Assurance Engineering support during Product Development or post-market changes.
• Collaborate cross-functionally to drive continuous process improvements using Quality Systems.
• Ensure product specifications are met and documentation is complete.
• Lead verification and validation activities, including protocol/report development and test method validation.
• Lead risk management activities, including hazard analysis and FMEA.
• Build and maintain strong relationships with internal teams and suppliers.
• Participate in product development, design reviews, and change control.
• Conduct risk analysis on new designs and processes.
• Support calibration systems, equipment qualification, and preventive maintenance.
• Assist with raw material/component inspections and non-conformance investigations.
• Ensure supplier compliance with regulatory standards.
• Support production control, test method validations, and Gauge R&R.
• Conduct internal audits and support CAPA processes.
• Participate in third-party audits and inspections.
• Assist with management reviews and provide necessary reports.

Qualifications:

• Bachelor’s degree in Engineering or related field.
• 5+ years of experience as a Quality Engineer in medical device manufacturing.
• Proven experience in design transfer, yield improvement, and scale-up projects.
• Proficient in writing protocols, evaluating testing results, and conducting product/process validation.
• Strong understanding of QMS and regulatory compliance (domestic/international).
• Excellent communication skills and the ability to collaborate across teams.
• In-depth knowledge of manufacturing quality control and process improvement.

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