What are the responsibilities and job description for the Senior Quality Engineer position at Insight Global?
*This is a hybrid on site, 6 month contract role*
Required Skills & Experience
- Bachelor's Degree in engineering, science, or related technical field from an accredited school is required
- 4 - 6 years of experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical)
- Knowledge/experience with ISO 14971 and ISO13485
- Fundamental technical understanding of manufacturing equipment and processes
- Expertise in measuring techniques
- Expectations of regulated bodies (Design control, Good documentation practices, Good manufacturing practices, and Organizational requirements)
- 1-2 years' experience within design control/design changes, and developing new test methods
- Experience with NPD or LCM products
Nice to Have Skills & Experience
- Experience with Minitab
- Relevant advanced degree preferred
- NPD experience within Medical Device
Job Description
A large life sciences client of ours is looking for a senior quality engineer to join their team for a 6-month project (with possibility of extension). This individual will be working on a large New Product Development project. They will develop and maintain risk management documentation to support product development, identify potential device risks, assess their impact, and develop mitigation strategies, and ensure compliance with industry standards and regulatory requirements.
They will also gather and document design inputs and outputs, create and maintain design validation files, and ensure all design requirements are measurable and validated through appropriate testing. This role entails developing and implementing studies to test product performance and reliability, creating sampling plans for studies and analyzing data to ensure product specifications are met. This individual will write detailed protocols for product studies, improve protocols based on feedback and testing results, and document and report findings and improvements after testing. They will • Implement production and process controls using appropriate techniques (for example, process capability measures, statistical process controls, and process performance metrics), perform or guide Measurement Systems Analysis (MSA) and basic reliability testing/analysis, and support the qualification of components and/or processes at external suppliers. This is hybrid 3x a week in Raritan, NJ.
