Quality Engineer II

About the role

A Day in the Life In this meaningful role as a Quality Engineer II supporting Cardiac Ablation Solutions (CAS), you will play a vital part in ensuring product quality, safety, and reliability through post-market activities. You will perform complaint investigations, partner closely with engineering teams to identify and escalate risk file signals, and support data-driven decisions that protect patients and clinicians. This role supports the development and continuous improvement of procedures, processes, tools, and techniques used for product analysis and returned product evaluation. You will devise and implement inspection and testing methods for returned product, support test method validation efforts, and apply appropriate statistical methodologies to assess product performance and trends. In addition, this position contributes to building organizational capability by providing training to technicians and strengthening consistent, compliant execution of quality practices—directly supporting patient safety and the CAS product lifecycle.

Responsibilities

• Perform complaint investigations for Cardiac Ablation Solutions products
• Collaborate with the engineering team to escalate risk file signals as appropriate.
• Provide support with the development of procedures, processes, tools, and techniques for performing product analysis.
• Devise and implement methods and procedures for inspection and testing of returned product.
• Support test method validation activities.
• Apply and understand statistical methodologies, as appropriate.
• Provide training to technicians.

Requirements

• Bachelor’s degree in Engineering, Science, or a related technical discipline.
• Minimum of 2 years of relevant experience in Engineering and or Quality, or an advanced degree in Engineering, Science, or a related technical discipline with 1+ years of relevant work experience in Engineering and or Quality.

Nice to Have

• Medical device industry experience.
• Familiarity with these regulations: FDA 21 CFR Part 820, EU 217/745 (EU MDR).
• Familiarity with these standards: ISO 13485, ISO 14971, IEC 60601.
• Knowledge of Microsoft Office Applications (Word, Excel, Access, and PowerPoint) and Windows OS.
• Strong written and verbal communication skills and ability to work cooperatively as part of a cross-functional team.

Qualifications

To be considered for this role, please ensure the minimum requirements are evident on your resume.

Skills

Not specified

Benefits

The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location.

Pay

$79,200.00 - $118,800.00

Schedule

Not specified