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Senior Quality Engineer - Medical Devices

Location: Maryland

Senior Quality Engineer needed for medical technology development company – a renowned pioneer in wearable health monitoring devices.

Will be responsible for supporting global reporting and management of communications between manufacturers, distributors and authorities for medical device complaint related activities. Specific responsibilities will include:

• Lead analysis and information management for medical device complaint events, case processing and assessment for post-marketing activities.
• Evaluate and engage management for critical events, and coordinate with internal functions (such as Quality, Regulatory, Manufacturing, R&D, Medical Affairs, and Customer Service) to gather input into medical device event reports.
• Review complaint investigation reports and provides comments.
• Document regulatory decisions on complaints in accordance with established regulations.
• Coordinate and prepare responses to competent authority inquiries for medical device reports (injuries or device malfunctions).
• Assist in preparing for notified body audits and authority inspections.
• Support root cause investigations and participate in CAPA activities.
• Generate complaint handling trending reports for management reviews and regulatory submissions.

Compensation: $92 - 105K, depending upon experience level

Relocation assistance provided.

Qualifications:

• Minimum BS in Engineering (or relevant technical degree) and 4+ years of applicable experience.
• Knowledgeable with regulatory standards (such as ISO-13485, ISO-14971, 21 CFR 820, etc.).
• Strong organizational and problem solving capabilities.
• Effective verbal and written communication skills.


This is a unique chance to join a dynamic and rewarding work environment, and participate in the evolution new products.