About the role
Job title: Quality Engineer – Post-Market Surveillance
Location: Covington, GA 30014
Industry: Medical Technology
Employment Type: Contract
Duration: 6 months (possible extension / full-time employment)
Pay Rate: $38.00/hr on W2
Schedule: Monday–Friday, 8:00 AM–5:00 PM
Work Arrangement: 4 days in office, 1 day remote
Experience: 1–3 years
Application deadline: August 25, 2026
Job Summary
A Quality Engineer in Post-Market Surveillance (PMS) is responsible for executing and coordinating the day-to-day operations of the post-market surveillance program and related processes. The primary responsibilities include reviewing various data sources, analyzing findings, and preparing summary reports for marketed products.
This position also performs quality engineering activities in support of the Quality organization. The PMS Quality Engineer will thrive in analyzing and summarizing data and collaborating cross-functionally with Quality, R&D, Regulatory, Clinical Affairs, Marketing, and Operations to complete projects and reports.
The PMS Quality Engineer will operate within a mature quality system that complies with FDA regulations, ISO standards, MDR requirements, and applicable international regulations governing products manufactured.
Job Responsibilities
- Ensure post-market surveillance (PMS) activities are completed on time and in compliance with applicable laws, regulations, and company procedures.
- Develop and maintain post-market surveillance plans and reports, including compilation and analysis of data from various sources.
- Accurately represent product post-market performance and summarize findings and conclusions.
- Drive changes to product documentation to address gaps identified during post-market surveillance reviews.
- Implement changes to the PMS process, including practices, procedures, and associated documentation, as required.
- Coordinate and collaborate with Quality, R&D, Regulatory, Clinical Affairs, Marketing, and Operations teams to facilitate completion of PMS reviews.
- Build productive and effective cross-functional working relationships.
- Identify issues requiring escalation and appropriately communicate them to management for resolution.
- Ensure compliance with company procedures, applicable laws, regulations, and standards when performing assigned responsibilities.
Education and Experience
Required
- Bachelor’s degree (B.S.) in Engineering, Science, Mathematics, or a related field.
- 1–3 years of Quality experience in a medical device, pharmaceutical, or other regulated industry.
Preferred
- 1–3 years of experience in Post-Market Surveillance within the medical device industry.
- American Society for Quality (ASQ) certification(s), such as CQE or CQA.
Knowledge and Skills
Required
- Proficiency in writing detailed summary reports and analyzing data to draw meaningful conclusions.
- Strong verbal, written, and presentation communication skills.
- Proficiency with Microsoft Office Suite, including Word, Excel, and PowerPoint.
- Effective listening, questioning, problem-solving, conceptual thinking, and analytical skills.
- Ability to manage multiple assignments and projects concurrently.
- Ability to work effectively within a cross-functional team and influence stakeholders to complete deliverables on time.
- Basic understanding of product risk management and related deliverables, including:
- Risk Management Plan
- Failure Mode and Effects Analysis (FMEA)
- Benefit-Risk Analysis
- Risk Management Report
- Basic knowledge and understanding of applicable global regulations, requirements, and standards, including:
- ISO 13485:2016
- FDA Quality System Regulation (QSR)
- EU Medical Device Regulation (EU) 2017/745
- SOR/98-282 Medical Device Regulations (Health Canada)
- ISO 14971:2019
- Basic knowledge of statistical techniques.
Preferred
- Strong attention to detail.
- Proficient understanding of product risk management.
- Ability to operate efficiently, proactively, and effectively.
- Advanced problem-solving skills.
EEOC Compliance
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment.
DISCLAIMER
AI Usage Policy: Pacer Group uses AI to assist in screening applications. Final hiring decisions are made by human recruiters based on qualifications and experience.
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