Quality Engineer

Argon Medical Devices Inc • Plano, TX

10d

About The Position

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.

Requirements

• 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

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 251-500 employees