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Quality Engineer

Company Overview::

Argon Medical Devices is a global manufacturer of specialty medical products. 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 compass 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 / AGENCIES!!!

This position is not eligible for visa sponsorship

Position Overview::

The Quality Engineer, Post Market Experience plays a key role in data-driven post-market surveillance, analyzing complaint, vigilance, and field performance data using tools such as Power BI to identify trends, detect potential safety signals, and support risk management activities. This role assists in evaluating regulatory requirements for product impact and supports the development and maintenance of post-market surveillance documentation and procedures.

What you will do::

Analyze complaint, adverse event, and medical device reporting data to identify trends and communicate findings to internal stakeholders.
Support preparation and maintenance of global post-market surveillance documentation including:
- Post Market Surveillance Plans (PMSP)
- Periodic Safety Update Reports (PSUR)
- Post Market Surveillance Reports (PMSR)
- Summary of Safety and Clinical Performance (SSCP)
Assist in the development and implementation of quality system processes supporting EU MDR post-market surveillance requirements.
Support preparation of technical reports related to product performance, safety, and complaint trending.
Assist in monitoring post-market data including complaints, adverse events, CAPA trends, and field actions to identify potential safety signals.
Support data analysis and visualization activities related to post-market surveillance using tools such as Power BI or similar reporting platforms.
Participate in cross-functional product review and risk review meetings to provide post-market performance insights.
Assist with regulatory submissions, audits, and inspections related to post-market surveillance activities.
Support new product development activities related to post-market surveillance planning and risk management.

Skills for Success::

Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, or related technical discipline
2–5 years of experience in Quality Engineering, Post Market Surveillance, or medical device quality/regulatory roles
Experience working within a regulated healthcare environment (ISO 13485 and/or 21 CFR Part 820)
Hands-on experience with data analysis, including use of tools such as Power BI, Excel, or similar platforms
Experience analyzing complaint or post-market data
Self-directed with ability to complete tasks in accordance with deadlines
Critical thinking and problem solving
Strong written and verbal communication skills
Strong data analysis and data visualization skills (Power BI or similar tools)
Data analysis, interpretation, and presentation
Attention to detail and regulatory documentation accuracy

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