Quality Engineer

Intellectt Inc; California; On-site; USD 48,000 - 69,000; Full time

Benefits offered by this job

Health Insurance

401(k) Retirement

PTO

Job summary

Intellectt Inc. is seeking a Quality Complaints Handling / Post-Market Surveillance (PMS) Specialist in California. You will own end-to-end complaint processes, investigate events, and ensure compliance with FDA MDR, EU MDR, ISO 13485, and ISO 14971.

You will collaborate with Quality, Regulatory Affairs, Engineering, Manufacturing, Clinical, and Supplier Quality, maintaining audit-ready records in TrackWise/Agile QMS.

Qualifications

• 1–5 years in medical device complaints handling or PMS.
• Experience with FDA MDR (21 CFR Part 803) and EU MDR.
• Experience with RCA/RCCA and regulatory adverse event reporting.
• Proficiency with eQMS / TrackWise / Agile PLM.
• Strong documentation and data analysis skills.

Responsibilities

• Handle end-to-end medical device complaint processes from intake to closure.
• Investigate complaints, malfunctions, adverse events using RCA/RCCA.
• Assess MDR and vigilance reporting per FDA and international standards.
• Perform PMS data analysis to identify trends and risks.
• Support CAPA, risk management, and quality improvements.
• Collaborate with Quality, Regulatory, Engineering, Manufacturing, Clinical, and Supplier Quality.
• Maintain audit-ready complaint records in eQMS (TrackWise/Agile).

Skills

MDR knowledge

PMS experience

Regulatory reporting

Cross-functional comms

Documentation

Tools

TrackWise

Agile PLM

Job description

Description

we are seeking a Quality Complaints Handling / Post-Market Surveillance (PMS) Specialist to manage end-to-end medical device complaint handling, post-market surveillance activities, regulatory assessments, and product quality trending.

Responsibilities

• Manage end-to-end medical device complaint handling, including intake, triage, investigation, documentation, and closure.
• Investigate product complaints, malfunctions, adverse events, and performance issues using RCA/RCCA and technical investigation methods.
• Assess complaints for FDA Medical Device Reporting (MDR) and international vigilance/reporting requirements.
• Perform complaint trending and PMS data analysis to identify recurring issues, failure modes, and emerging product risks.
• Support CAPA, risk management, nonconformance, and corrective action activities resulting from complaint trends and quality escalations.
• Work closely with cross-functional teams including Quality, Regulatory Affairs, Engineering, Manufacturing, Clinical, and Supplier Quality.
• Ensure full compliance with FDA regulations, ISO 13485, ISO 14971, and EU MDR standards.
• Maintain complete, audit-ready, and accurate complaint records within electronic Quality Management Systems (eQMS / TrackWise / Agile).

Required Skills & Qualifications

• 1-5 years of hands-on experience in medical device complaints handling, Post-Market Surveillance (PMS), vigilance, Quality Engineering, or related regulatory areas.
• Strong working knowledge of FDA MDR (21 CFR Part 803), EU MDR, ISO 13485, and ISO 14971 risk management standards.
• Hands-on experience with complaint investigations, product trending, CAPA, Root Cause Analysis (RCA/RCCA), and regulatory adverse event reporting.
• Demonstrated proficiency using eQMS / complaint management software (e.g., TrackWise, Agile PLM).
• Exceptional technical documentation, data analysis, and cross-functional communication skills.

Pay Scale

$35-$50/HR on W2 (Negotiable based on experience)

Benefits

Employees hired into this position are eligible for the following benefits, subject to the applicable plan terms and eligibility requirements:

• Health Insurance: Medical, dental, and vision insurance options are available through a third-party provider. Employees are responsible for paying the full cost of their insurance premiums.
• Retirement Benefits: A 401(k) retirement savings plan is available. No employer matching or other employer contributions are provided.
• Paid Time Off (PTO): No PTO other than that required by applicable state and local laws.