Medical Device Complaints & Quality Investigator

Spectrum Vascular; Northern (KY); Hybrid; USD 50,000 - 75,000; Full time

Job summary

Spectrum Vascular is seeking a Complaint Specialist to receive, document, investigate, and resolve product complaints in line with FDA QMSR, ISO 13485, and MDR requirements. You will collaborate with Quality, Regulatory, Engineering, and CMO teams to ensure timely resolutions and continuous product improvement.

The ideal candidate has a Bachelor's degree with at least 3 years of medical device complaint handling experience, strong regulatory knowledge, and meticulous attention to detail.

Qualifications

• Bachelor’s degree in a technical, scientific, or business-related discipline preferred.
• 3 years related work experience as a complaint handler in the medical device industry, performing all duties described above.
• Knowledge of medical terms and Medical Device Reporting regulations (MDR).
• Exceptional organizational skills and attention to detail.
• Able to perform job function with minimal supervision and work independently.

Responsibilities

• Receives, documents, investigates, and resolves product complaints in accordance with company policies and regulatory requirements.
• Coordinates complaint investigations and communicates with health care providers and patients to obtain relevant information.
• Enters product complaint information into the complaints database and contributes to root cause investigations with cross-functional teams.
• Supports CAPA activities and assists with development and improvement of complaint handling procedures and forms.
• Prepares and submits reports to US FDA and other regulatory agencies within required timeframes.
• Maintains confidentiality and integrity of complaint files and records.

Skills

Complaint handling

Regulatory reporting

Cross-functional teamwork

Communication

Quality systems

CAPA

Trend analysis

Documentation

Root cause

Process improvement

Education

Bachelor’s degree

3 years experience in medical device complaints

Regulatory knowledge (RDR/ MDR)

Attention to detail

Job description

Spectrum Vascular is seeking a Complaint Specialist to receive, document, investigate, and resolve product complaints in line with FDA QMSR, ISO 13485, and MDR requirements. You will collaborate with Quality, Regulatory, Engineering, and CMO teams to ensure timely resolutions and continuous product improvement.

The ideal candidate has a Bachelor's degree with at least 3 years of medical device complaint handling experience, strong regulatory knowledge, and meticulous attention to detail.