Quality Engineer - Post Market

Argon Medical Devices Inc; Athens (TX); On-site; USD 85,000 - 125,000; Full time

Job summary

Argon Medical Devices Inc in Plano, Texas, is seeking a Quality Engineer (Post-Market) – Complaints Investigator to lead complaint evaluations, determine root causes, and ensure timely closure of records.

You will collaborate across Regulatory, Manufacturing, Engineering, and Customer Service to support post-market surveillance, CAPA, risk assessment, and regulatory reporting including MDR, while maintaining compliance with FDA QSR 820 and ISO 13485.

Qualifications

• Bachelor's degree in engineering, Life Sciences, Quality, or related technical field required.
• 3+ years of Quality Engineering, Complaint Investigation, Post-Market Surveillance, or Medical Device Quality Systems experience required.
• Experience conducting complaint investigations, root cause analysis, and product performance evaluations required.
• Strong knowledge of FDA Quality System Regulations, ISO 13485, ISO 14971, MDR, and post-market surveillance requirements required.
• Experience with CAPA, nonconformance management, risk assessment, and quality system processes required.
• Working knowledge of medical device adverse event reporting and regulatory compliance requirements are preferred.
• Strong analytical, technical writing, problem-solving, and communication skills required.
• Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent certification preferred.
• Experience supporting regulatory inspections and third-party audits preferred.

Responsibilities

• Lead complaint evaluations and investigations to determine product failure modes, identify root causes, assess patient and user impact, and ensure timely closure of complaint records.
• Perform risk assessments associated with customer complaints, product performance issues, and adverse events to determine product safety impact and support risk management activities.
• Analyze complaint and post-market surveillance data to identify trends, emerging quality signals, and opportunities for product and process improvement.
• Assess complaints for reportability and support regulatory reporting activities, including MDR, Vigilance Reporting, Field Actions, and other applicable global regulatory requirements.
• Lead investigations of product nonconformances, quality issues, and product performance concerns identified through post-market monitoring activities.
• Collaborate with cross-functional teams, including Regulatory Affairs, Medical Affairs, Manufacturing, Engineering, and Customer Service, to investigate and resolve product quality issues.
• Initiate and support CAPA, ensuring appropriate containment, root cause analysis, effectiveness verification, and documentation.
• Maintain and support risk management activities by evaluating complaint trends and post-market data for potential impacts to product risk profiles, hazard analyses, and risk management files.
• Ensure compliance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, ISO 14971, MDR, Medical Device Vigilance, and other applicable global regulations.
• Travel 5-10% as required.

Skills

Quality Engineering

Root Cause Analysis

Regulatory Knowledge

Education

Bachelor's degree in engineering or life sciences

Job description

Company Overview:

Argon Medical is a global manufacturer of specialty medical products, headquartered in Plano, Texas. Argon offers a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Oncology. Argon’s brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures. Our values describe what we believe in and how we operate. These values are our moral compasses which guide our decisions and define the deeply held beliefs and principles of our organizational culture. Argon Medical is a family of individuals united by a mission and culture which continue to grow stronger every day.

ARGON MEDICAL DEVICES IS NOT LEVERAGING SEARCH FIRMS

Position Overview:

The Quality Engineer (Post-Market) - Complaints Investigator is responsible for investigating product complaints, evaluating product performance and safety issues, and supporting post-market quality activities to ensure compliance with applicable regulatory requirements and internal procedures. This role provides quality engineering support for complaint handling, post-market surveillance, risk management, regulatory reporting, and continuous improvement initiatives to ensure product quality, patient safety, and regulatory compliance throughout the product lifecycle.

What you will do:

Primary Duties

• Lead complaint evaluations and investigations to determine product failure modes, identify root causes, assess patient and user impact, and ensure timely closure of complaint records.
• Perform risk assessments associated with customer complaints, product performance issues, and adverse events to determine product safety impact and support risk management activities.
• Analyze complaint, and post-market surveillance data to identify trends, emerging quality signals, and opportunities for product and process improvement.
• Assess complaints for reportability and support regulatory reporting activities, including Medical Device Reporting (MDR), Vigilance Reporting, Field Actions, and other applicable global regulatory requirements.
• Lead investigations of product nonconformances, quality issues, and product performance concerns identified through post-market monitoring activities.
• Collaborate with cross-functional teams, including Regulatory Affairs, Medical Affairs, Manufacturing, Engineering, and Customer Service, to investigate and resolve product quality issues.
• Initiate and support Corrective and Preventive Actions (CAPA), ensuring appropriate containment, root cause analysis, effectiveness verification, and documentation.
• Maintain and support risk management activities by evaluating complaint trends and post-market data for potential impacts to product risk profiles, hazard analyses, and risk management files.
• Ensure compliance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, ISO 14971, Medical Device Reporting (MDR), Medical Device Vigilance, and other applicable global regulations.

Travel 5-10% as required.

Skills for Success:

• Bachelor's degree in engineering, Life Sciences, Quality, or related technical field required.
• 3+ years of Quality Engineering, Complaint Investigation, Post-Market Surveillance, or Medical Device Quality Systems experience required.
• Experience conducting complaint investigations, root cause analysis, and product performance evaluations required.
• Strong knowledge of FDA Quality System Regulations, ISO 13485, ISO 14971, Medical Device Reporting (MDR), and post-market surveillance requirements required.
• Experience with CAPA, nonconformance management, risk assessment, and quality system processes required.
• Working knowledge of medical device adverse event reporting and regulatory compliance requirements are preferred.
• Strong analytical, technical writing, problem-solving, and communication skills required.
• Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent certification preferred.
• Experience supporting regulatory inspections and third-party audits preferred.