Quality Engineer

Job Description

This person will be responsible for monitoring product performance, investigating customer complaints, and analyzing post-market surveillance data to identify trends, risks, and opportunities for product improvement. They will partner with cross-functional teams to assess field performance signals, support risk management activities, and ensure patient safety. They will conduct complaint investigations, reviews returned product analyses, performs data-driven evaluations using statistical methods, supports regulatory requests, and communicates product performance findings to stakeholders. This person will assist with electronic circuit and component investigations, collaborates with lab technicians on product evaluations, and drives continuous process improvements in a regulated medical device environment.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to View email address on click.appcast.io learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy:

Skills and Requirements

• Must have an electrical background.

- Experience with Investigating and/or reviewing electronic circuits and components.

- Bachelor's degree in EE or Biomed

- Understanding and a command of highly technical engineering topics and applied statistics.

- Ability to independently manage project work to define and consistently meet delivery dates.

Understanding and experience operating within quality system processes and procedures. • Engineering Degree with 2-3 years of relevant medical device experience.

• Experience in physical device analysis.

• Strong technical understanding of medical device therapy products.

• Significant participation in the Hazard Analysis and Risk Assessment as related to trend management.

• Experience with the quality system escalations, CAPA investigations and field assessments.

• Strong understanding of the medical device regulatory requirements of post-market complaint tracking, trending and analysis.

• Project experience and/or collaboration with Medical Safety, Design Assurance, Return Product Analysis, Supplier Development and Manufacturing.