Engineer, Quality

The Engineer, Quality position involves initiating quality assurance activities for medical devices in compliance with FDA regulations and international standards. The role supports complaint investigations, develops inspection processes, and manages quality system metrics.

• Initiate medical device quality assurance activities in compliance with regulations.
• Support device complaint investigation and failure analysis.
• Develop and document incoming inspection processes.
• Manage the sterilization process and validate product sterile loads.
• Track nonconforming materials and lead Material Review Board efforts.
• Lead complaint investigations and manage corrective action activities.
• Assist in internal quality system auditing and support management review meetings.

• 2–3 years of Quality Engineering experience, preferably in Medical Device Manufacturing.
• Experience in a highly regulated industry (Pharma or Electronics acceptable).
• Skills in risk assessment, corrective actions, and inspection plan creation.
• Strong problem-solving abilities and project management skills.
• Ability to work independently and manage time effectively.
• Proven track record of quickly adapting to new projects and maintaining a strong work ethic.
• Experience with CAPA and documentation change management.