Quality Specialist

Description:

A fast-growing, global medical device company dedicated to advancing organ transplantation through innovative technologies is seeking a Quality Specialist - Adverse Event Reporting to join their team at their U.S. headquarters. This permanent, full-time position supports post-market surveillance activities, ensuring proper communication and compliance with regulatory authorities regarding medical device complaints.

Key Responsibilities:

• Complaint Management: Initiate and manage complaint files, ensuring accuracy and completeness.

• Adverse Event Reporting: Collect information regarding complaints from customers and field representatives, submitting reports to regulatory bodies (e.g., FDA, Health Canada).

• Escalation and Prioritization: Escalate adverse events based on risk level, and prioritize complaints based on impact to patient safety and regulatory compliance.

• Investigation and Analysis: Facilitate return and investigation of devices related to complaints and generate investigation summaries with cross-functional input.

• Regulatory Submissions: Contribute post-market surveillance data for regulatory submissions and ensure compliance with medical device regulations in the UK, EU, and Australia.

• Complaint Resolution: Close complaints within defined timelines and ensure proper documentation.

• Metrics and Data Requests: Support internal teams with generating metrics and data requests related to complaints.

• Cross-functional Collaboration: Participate in cross-functional meetings and contribute to continuous improvement efforts.

• Travel Requirements: Occasional travel, up to 10%, including international travel when necessary.

Qualifications:

• Educational Requirements: Bachelor’s degree in science, engineering, nursing, or a related field, or equivalent work experience.

• Experience: Minimum 5 years in a similar role within the medical device industry.

• Regulatory Knowledge: Solid understanding of medical device complaint handling and reporting (21 CFR 803, 820; Health Canada SOR/98-282).

• Complaint Tracking Systems: Familiarity with systems such as MasterControl or TrackWise.

• CAPA Processes: Understanding of CAPA processes and medical device regulations in the UK, EU, and Australia.

• Transplantation Experience: Exposure to organ perfusion or transplantation terminology and concepts is a plus.