POSITION SUMMARY:

The person in this position investigates customer complaints, facilitates investigations, generates complaint investigation reports, and ensures completeness and consistency of the complaint files and records documentation. As an integral part of the quality team they are responsible for supporting the development, implementation, and maintenance of quality systems to ensure compliance with EN ISO 13485:2016, CMDR (Canadian Medical Device Regulations), MDD (Medical Device Directive) and FDA QSR.

DUTIES & RESPONSIBILITIES:

• Ensure complaint management activities are conducted in a proper and timely manner, including receipt from the field, investigation receipt and closure.
• Work collaboratively with other departments on complaint event analysis.
• Conduct complaint in-take, professionally interact with internal and external customers.
• Conduct or support failure analysis, problem solving and root cause investigation.
• Work cross-functionally with Customer Service, Sales, and R&D to complete and document complaint investigations.
• Help facilitate RGA System by reviewing RGAs for potential complaints and closing them as appropriate.
• Inspect returned product for stock acceptability
• Help facilitate NCR and Deviation Systems by initiating, closing and reviewing NCRs and Deviations as necessary for general compliance and completeness.
• Initiate and review ECOs as necessary to ensure correct and complete and to detect any compliance issues

JOB REQUIREMENTS:

• Bachelor’s degree or related technical technical experience
• 2-3 years’ experience in a quality role in the medical device industry, preferably with a Class III medical device.
• Understanding of design controls, risk management, statistical techniques, complaints/MDRs, NCRs/MRB, Deviations, RGAs, CAPAs/SCARs, internal audits, and supplier audits.

FUNCTIONAL/TECHNICAL/SKILLS REQUIRED:

• Knowledge of Complaint Handling and FDA Medical Device Reporting
• Knowledge of CAPA/SCAR system.
• Knowledge of trending and analysis of Quality Data.
• Coordinate or conduct Supplier Audits.
• Understands basic statistical data analysis.
• Proficiency with MS Word, MS Excel, and MS Visio.
• High level of attention to detail and organization.
• Proven ability to effectively work cross-functionally at all levels of the organization.
• Must be able to function in a typical startup environment (fast pace, multi-tasking, tight deadlines).
• Excellent verbal, written, and presentation communication skills.
• Understanding of Medical Device Risk management.
• Working knowledge of current EN ISO 13485:2016, CMDR (Canadian Medical Device Regulations), MDD (Medical Device Directive) and FDA QSR.

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