Remote Senior Quality & Post-Market Complaints Specialist

Implantica; United States; Remote; USD 110,000 - 140,000; Full time

Job summary

Implantica is seeking a Sr. Product Quality Complaint Specialist to manage timely and thorough investigations of medical device complaints within an eQMS that meets regulatory requirements in regions where the business operates.

This role supports post‑market surveillance and cross‑functional collaboration in a remote US setting. The ideal candidate has 4+ years in Quality/PMS for medical devices, a clinical/medical degree, and strong knowledge of 21 CFR Part 820, MDR, ISO 13485, and MDSAP.

Qualifications

• Demonstrated experience in Quality/PMS within medical devices.
• Prerequisite degree in clinical/medical services (ADN/BSN/RN/NP/MD).
• Experience with US regulatory requirements (FDA/ISO).
• Familiarity with QMS software and data handling.

Responsibilities

• Lead complaint investigations and closure of records.
• Maintain electronic complaint database in compliant eQMS.
• Classify complaints and escalate for regulatory reporting where needed.
• Submit incident/adverse event reports timely.
• Communicate with clinicians, sales, and customers to gather details.
• Identify trends and initiate corrective actions as appropriate.

Skills

Quality mindset

Analytical thinking

Cross-functional collaboration

Written and verbal communication

Education

Clinical/medical degree (ADN/BSN/RN/NP/MD)

Tools

QMS software

Microsoft Excel

Charting programs

Regulatory documentation

Job description

Implantica is seeking a Sr. Product Quality Complaint Specialist to manage timely and thorough investigations of medical device complaints within an eQMS that meets regulatory requirements in regions where the business operates.

This role supports post‑market surveillance and cross‑functional collaboration in a remote US setting. The ideal candidate has 4+ years in Quality/PMS for medical devices, a clinical/medical degree, and strong knowledge of 21 CFR Part 820, MDR, ISO 13485, and MDSAP.