Medical Device Complaint Specialist

Spherion Staffing Corporation; San Jose (CA); On-site; USD 90,000 - 130,000; Part time

Job summary

Spherion Staffing Corporation is seeking a quality systems professional for a contract role in the SF Bay Area. The position focuses on complaint management, post-market surveillance, and regulatory submissions across global markets, with on-site work 3 days a week.

The candidate will partner with cross-functional teams to drive CAPAs, update risk management files, and support audits under QMS/EHS policies. 5+ years in medical device quality is required.

Qualifications

• Minimum 5+ years in medical device quality systems and post-market surveillance.
• Experience preparing regulatory submissions for domestic and international bodies.
• Strong CAPA, risk management, and trend analysis skills.

Responsibilities

• Oversee complaint handling workflows from intake to closure and perform root cause analysis.
• Conduct reportability assessments and adverse event filings across global markets.
• Track post-market data to identify failure modes, trends, and recall triggers.
• Collaborate with Design Quality Engineering to update Risk Management files and drive CAPAs/SCARs.
• Draft PMS plans, PMS-R, and PSUR documents; support audits per QMS/EHS policies.
• Draft responses to client failure analyses and help refine system procedures.

Skills

Quality systems

Regulatory submissions

CAPA management

Post-market surveillance

Root cause analysis

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Job Description

Position Type: Contract (Potential Temp-to-Perm)

Location: SF Bay Area (On-site 3 days/week)

Role Overview & Key Responsibilities

• Complaint Management & Lifecycle Investigations: Oversee complete complaint handling workflows from intake to closure. Execute Good Faith Efforts (GFE) for product returns, gather clinical/field context from cross-functional teams, and perform root-cause failure analysis.


• Global Regulatory Submissions: Conduct reportability assessments and timely adverse event filings across global markets in accordance with relevant standards (US FDA 21 CFR 803 MDRs, EU MDR/MDD Vigilance, Health Canada, PMDA, and NMPA).


• Data, Trend Analysis & Recall Prevention: Track, summarize, and evaluate post-market surveillance data to identify emerging failure modes, escalating complaint trends, and potential recall triggers. Present findings and actionable recommendations during management reviews.


• Quality Engineering & Corrective Actions: Partner with Design Quality Engineering to update Risk Management files based on new failure modes or occurrence frequencies. Drive CAPAs and SCARs when complaint metrics exceed expected baselines.


• Surveillance Documentation & Audit Support: Author and maintain PMS plans, Post-Market Surveillance Reports (PMS-R), and Periodic Safety Update Reports (PSUR). Support internal and external regulatory body audits, ensuring alignment with the organization's Quality Management System (QMS) and EHS policies.


• Policy & Customer Interfacing: Draft responses to client failure analysis requests and collaborate with leadership to refine system-level procedures and quality policies.

Qualifications & Requirements

• Experience: 5+ years in medical device quality systems, with at least 5 years dedicated to post-market surveillance, complaint handling, and adverse event reporting.


• Industry Focus: Medical device background strongly preferred; pharmaceutical quality experience will also be considered.


• Regulatory Competency: Hands‑on experience executing adverse event submissions for both domestic and international regulatory bodies.


• Education: Bachelor’s degree in Engineering, Life Sciences, or equivalent practical industry experience.


• Work Arrangement: SF Bay Area-based with the ability to work on‑site 3 days per week.

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Company Description

We're a national recruiting and staffing enterprise that blends the resources of the world's largest talent company with the local insights of our independent franchise owners. A pioneer in the staffing industry, we’ve been providing companies with the workforce solutions they need for over 80 years while helping people find jobs and build careers where they can thrive.

We're a national recruiting and staffing enterprise that blends the resources of the world's largest talent company with the local insights of our independent franchise owners. A pioneer in the staffing industry, we’ve been providing companies with the workforce solutions they need for over 80 years while helping people find jobs and build careers where they can thrive.