Quality Assurance Specialist

Mindlance; Alameda (CA); On-site; USD 70,000 - 100,000; Full time

Job summary

Mindlance is seeking a Post-Market Surveillance Analyst to monitor safety, performance, and quality of medical devices after market release. You will analyze complaints, adverse events, and product performance while ensuring regulatory compliance.

The role involves preparing PMS plans and reports, supporting PSUR/PMCF documentation, and collaborating with QA, Regulatory, Clinical, and Risk teams to drive CAPA actions and risk management updates.

Qualifications

• Bachelor's or Master's degree in a related field.
• 2-5 years of experience in post-market surveillance or regulatory affairs.
• Knowledge of medical device regulations and post-market reporting requirements.
• Experience with complaint management systems, safety databases, and Excel or similar tools.

Responsibilities

• Perform post-market surveillance activities in line with regulatory requirements.
• Collect, review, and analyze post-market data including complaints and adverse events.
• Conduct complaint trending, signal detection, and statistical analyses to identify safety risks.
• Prepare and maintain PMS Plans, PMS Reports, PSURs, and PMCF documentation as applicable.
• Assist with MDR and vigilance reporting, including timelines and assessments.
• Coordinate with QA, Regulatory, Clinical, and Risk Management teams on investigations.
• Support CAPA investigations and risk management updates.
• Ensure compliance with EU MDR, FDA MDR, ISO 13485, and ISO 14971 as applicable.
• Maintain records for audits and regulatory inspections.
• Prepare dashboards and management summaries on product safety and performance.

Skills

Analytical

Documentation

Communication

Problem solving

Education

Bachelor's or Master's in Biomedical Engineering/Life Sciences/Pharmacy/Biotechnology

Tools

Excel

Job description

Job Description: Post-Market Surveillance (PMS) Analyst - Medical Devices

Job Title: Post-Market Surveillance Analyst

Industry: Medical Devices / Medical Technology

Department: Quality Assurance / Regulatory Affairs

Experience: 2-5 years (adjustable)

Location: As per business requirements

Job Summary

The Post-Market Surveillance (PMS) Analyst is responsible for monitoring the safety, performance, and quality of medical devices after they are placed on the market. The role involves complaint data analysis, adverse event reporting, trend analysis, preparation of PMS reports, and ensuring compliance with applicable regulatory requirements.

Key Responsibilities

• Perform post-market surveillance activities for medical devices in accordance with applicable regulatory requirements.
• Collect, review, and analyze post-market data, including customer complaints, adverse events, feedback, and product performance information.
• Conduct complaint trending, signal detection, and statistical analysis to identify potential safety risks.
• Support the preparation and maintenance of PMS Plans, PMS Reports, Periodic Safety Update Reports (PSURs), and Post-Market Clinical Follow-up (PMCF) documentation, as applicable.
• Assist with Medical Device Reporting (MDR) and vigilance reporting, including assessment of reportability and submission timelines.
• Investigate product complaints and coordinate with Quality, Regulatory Affairs, Clinical, and Risk Management teams.
• Support CAPA investigations, root cause analysis, and risk management file updates.
• Ensure compliance with applicable regulations and standards, including EU MDR 2017/745, FDA 21 CFR Part 803, ISO 13485, and ISO 14971, as relevant to the market.
• Maintain accurate records and documentation for audits and regulatory inspections.
• Prepare dashboards, periodic reports, and management summaries related to product safety and performance.

Required Qualifications

• Bachelor's or Master's degree in Biomedical Engineering, Life Sciences, Pharmacy, Biotechnology, or a related discipline.
• 2-5 years of experience in Post-Market Surveillance, Medical Device Vigilance, Complaint Handling, or Regulatory Affairs.
• Knowledge of medical device regulations and post-market reporting requirements.
• Experience with complaint management systems, safety databases, and Microsoft Excel or other data analysis tools.
• Strong analytical, documentation, communication, and problem-solving skills.

Preferred Skills

• Experience with EU MDR, FDA MDR, and applicable global vigilance requirements.
• Familiarity with PMS, PSUR, PMCF, CAPA, root cause analysis, and risk management documentation.
• Experience in medical device companies, CROs, or regulatory consulting organizations.
• Knowledge of electronic Quality Management Systems (eQMS) and complaint-handling platforms.
• PMS reports and trend analyses.
• Complaint and adverse event assessments.
• Safety signal evaluation and escalation.
• Support for CAPA and risk management updates.
• Audit-ready PMS documentation.

Candidate Profile

The ideal candidate should have strong analytical skills, attention to detail, regulatory documentation experience, and the ability to collaborate with cross-functional teams to support the ongoing safety and effectiveness of medical devices.

Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.