Shoolin Inc is a staffing and technology solutions company specializing in tailored talent acquisition and recruitment excellence across Science, Engineering, Technology, Clinical & Life Sciences, and Pharmaceutical sectors. They provide skilled staffing, innovative tech solutions, and master vendor services, focusing on matching the right talent with organizational needs for both short-term projects and specialized roles. Their approach emphasizes cultural fit and long-term partnerships, positioning them as a transformative growth catalyst in workforce solutions with a commitment to quality and industry expertise.
Shoolin Inc is a staffing and technology solutions company specializing in tailored talent acquisition and recruitment excellence across Science, Engineering, Technology, Clinical & Life Sciences, and Pharmaceutical sectors. They provide skilled staffing, innovative tech solutions, and master vendor services, focusing on matching the right talent with organizational needs for both short-term projects and specialized roles. Their approach emphasizes cultural fit and long-term partnerships, positioning them as a transformative growth catalyst in workforce solutions with a commitment to quality and industry expertise.
Our medical device client in San Diego, CA is seeking an experienced
Quality Inspector with strong Complaints Handling experience
to support post-market quality activities. The ideal candidate will have hands-on experience investigating product complaints, performing inspection activities, and ensuring compliance with FDA and ISO standards.
Key Responsibilities:
Required Skills & Experience:
2–4+ years of experience as a
Quality Inspector / Quality Technician / Complaints Investigator
in the
medical device industry
.
Hands-on experience inspecting returned products and performing complaint evaluations.
Strong understanding of
FDA regulations
,
ISO 13485
, and complaint handling procedures.
Experience with measurement tools (calipers, gauges, microscopes) and inspection equipment.
Perform
product inspection
(visual, mechanical, functional) on returned medical devices associated with complaints.
Review product documentation, inspection records, and device history records (DHRs).
Support
post-market surveillance
activities including trending, risk evaluation, and escalation of critical issues.
Ensure all complaint files, investigation notes, and inspection results comply with
FDA 21 CFR Part 820
, ISO 13485, and internal quality system requirements.
Collaborate with Quality Engineers, Manufacturing, and R&D to communicate investigation outcomes.
Maintain accurate records in complaint handling systems (e.g., TrackWise, Agile, ETQ).
Assist in determining if CAPA is needed based on complaint trends and investigation results.
Follow Good Documentation Practices (GDP) and maintain audit-ready files.
Proficiency with complaint management systems (TrackWise, ETQ, etc.).
Strong attention to detail and excellent documentation skills.
