Quality Engineer - Post Market

About the role

Argon Medical is a global manufacturer of specialty medical products for Interventional Radiology, Vascular Surgery, Interventional Cardiology and Oncology. 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.

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 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.

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, Medical Device Reporting (MDR), and post-market surveillance requirements required.
• Experience with CAPA, nonconformance management, risk assessment, and quality system processes required.

Preferred qualifications

• Working knowledge of medical device adverse event reporting and regulatory compliance requirements.
• Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent certification.
• Experience supporting regulatory inspections and third-party audits.

Skills

• Strong analytical, technical writing, problem-solving, and communication skills required.