Quality Engineer

Job Title: Quality Engineer
Department: Quality
Classification: Contract (6-months)
Position Summary
The Quality Engineer will support and maintain the Quality Management System (QMS) in a regulated medical device environment. This role is responsible for activities including document control, regulatory compliance, sterilization coordination, CAPA, risk management, and audit support related to the design, development, manufacture, and distribution of medical devices.
Key Responsibilities
• Ensure compliance with FDA 21 CFR 820, ISO 13485, ISO 14971, and applicable international medical device regulations (including MDR)
• Support and maintain compliance with QSR and GMP requirements across assigned areas
• Manage the Corrective and Preventive Action (CAPA) process from investigation through effectiveness checks
• Maintain Design History Files (DHF), Technical Files, and supporting documentation for internal and external audits
• Coordinate and support sterilization qualifications and ongoing maintenance activities
• Review and approve validation protocols and reports (IQ/OQ/PQ)
• Utilize quality tools such as FMEA, Control Plans, and Process Flow Diagrams
• Support risk management activities throughout the product lifecycle
• Develop, execute, and document department and company-wide training
• Organize and prioritize multiple tasks to meet project timelines and business needs
Prepare and review technical documentation with a high level of accuracy and clarity

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 HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Qualifications
Education:
• Bachelor’s Degree in Engineering or a related technical field
Experience:
• Minimum of 5 years of quality engineering experience in an ISO-regulated and/or medical device environment
Skills:
• Strong working knowledge of verification and validation processes
• Proficient in Microsoft Office (Word, Excel, Outlook)
• Excellent verbal and written communication skills in English
• Strong technical writing and documentation skills
• Experience with risk management methodologies preferred
Physical Requirements
• Ability to sit or stand for extended periods
Ability to work at a computer for normal business durations

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.