Job Details

Quality Engineer – Medical Device Complaint Investigations

Planet Pharma is seeking a Sr. Complaint Specialist to support medical device post‑market surveillance and complaint investigations. This position is responsible for handling device troubleshooting, tracking and shipping parts for analysis, and ensuring investigations and documentation meet quality and regulatory standards.

Base pay range

$42.00/hr - $47.00/hr

Schedule & Location

• Next phase: Shift changes to 11am–7pm for ~4 months
• Then: onsite in Otay Mesa (~25 min from San Diego), 8am–5pm schedule
• Flexibility: option to remain on the 11am–7pm shift if preferred

Key Responsibilities

• Conduct product complaint investigations and write detailed failure investigation reports
• Handle, track, and ship medical device components for analysis
• Maintain accurate complaint files in compliance with FDA and ISO 13485 standards
• Collaborate with internal teams to resolve issues and ensure proper documentation
• Support audits and provide input on root cause analysis and corrective actions

What We're Looking For

• 2+ years in a regulated industry (medical device, pharma, biotech, or electronics)
• Familiarity with complaint handling or post‑market surveillance processes
• Experience with Salesforce, TrackWise, and Excel highly preferred
• Strong attention to detail, organizational skills, and ability to work independently
• Excellent written communication and documentation accuracy

What This Role Offers

• Chance to work hands‑on with medical devices in a regulated lab environment
• Blend of technical, investigative, and documentation work

Seniority level

Mid‑Senior level

Employment type

Full‑time

Job function

Quality Assurance, Engineering, and Manufacturing

Industries

Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing