QA Complaint Specialist

QA Complaint Specialist at Tech Observer QA Complaint Specialist at Tech Observer in Poway, California Posted in 3 days ago.

Type:

full-time

Job Description:

Position

• QA Complaint Specialist Location
• San Diego, CA Contract
• 3 months

Key Responsibilities:

Receive and document medical device complaints from approved channels. Review, triage, and assess complaint information for completeness and follow-up needs. Enter accurate complaint details into eQMS systems. Coordinate with internal/external teams to gather missing information. Track complaint follow-ups, returned products, and supporting documentation. Support complaint investigations, verification, and regulatory reporting activities. Maintain compliant complaint records per

FDA, ISO

13485, and EU MDR requirements. Escalate serious or urgent complaints to QA Management. Provide complaint metrics, reports, and support post-market surveillance activities.

Qualifications :

1-3 years of experience in QA, medical devices, pharmaceuticals, or regulated industries preferred. Bachelor's degree in science, healthcare, technical, or quality-related field preferred. Experience with eQMS or complaint handling systems preferred. Strong attention to detail, organization, and communication skills. Proficient in Microsoft Office (Word, Excel, Outlook).