Post Market Surveillance; PMS Quality Engineer

Job Title:
Post Market Surveillance (PMS) Quality Engineer

Location: Minneapolis, MN (Hybrid – 3 Days Onsite)

Employment Type: Contract (W2 Only)

Experience: 0–3 Years

We are seeking a detail-oriented Post Market Surveillance (PMS) Quality Engineer to support post-market quality activities for medical devices. The ideal candidate will assist in monitoring product performance, investigating customer complaints, analyzing post-market data, and ensuring compliance with FDA, ISO 13485, and global regulatory requirements.

• Support Post Market Surveillance (PMS) activities for commercial medical devices.
• Review, document, and investigate customer complaints and product quality issues.
• Assist with complaint handling, adverse event reporting, and vigilance activities.
• Perform root cause analysis and support Corrective and Preventive Actions (CAPA).
• Analyze post-market quality data to identify trends and recommend improvements.
• Prepare PMS reports, complaint summaries, and quality metrics.
• Support Medical Device Reporting (MDR) activities and regulatory submissions when required.
• Participate in risk management activities in accordance with ISO 14971.
• Collaborate with Regulatory Affairs, Manufacturing, R&D, Clinical, and Customer Quality teams.
• Maintain complaint files and quality documentation in electronic Quality Management Systems (eQMS).
• Support internal audits, regulatory inspections, and quality system compliance.
• Ensure compliance with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, and company quality procedures.

• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Life Sciences, Biotechnology, Pharmacy, or a related field.
• 0–3 years of experience in Quality Engineering, Post Market Surveillance, Complaint Handling, or Medical Device Quality.
• Basic understanding of medical device quality systems and regulatory requirements.
• Strong analytical, problem-solving, and technical documentation skills.
• Excellent written and verbal communication skills.

• Knowledge of FDA 21 CFR Part 820, ISO 13485, and ISO 14971.
• Familiarity with complaint handling, CAPA, non-conformance (NCR), and root cause analysis.
• Experience with eQMS tools such as Track Wise, Master Control, Veeva, or Greenlight Guru is a plus.
• Exposure to Medical Device Reporting (MDR), vigilance reporting, and post-market surveillance processes.
• Understanding of statistical analysis and quality improvement methodologies is preferred.