Quality Engineer
- Princeton, NJ, United States
From $41 USD / hour
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Job details
- Pay
- From $41 USD / hour
- Experience
- Minimum of 3 years quality experience in the medical device industry
- Posting language
- English
- Posted
Original job description
Required Skills & Experience
BS/MS degree in related field (Engineering or related biomedical disciplines) Minimum of 3 years quality experience in the medical device industry Experience with FDA QMSR, ISO 13485 and ISO 14971 Experience with Medical Device Design & Development Experience with Risk Management tools such as FMEA, Fault Tree Analysis, Hazard Analysis etc.
Job Description
The Quality Engineer will partner with Technical Project teams to support change management projects and new product development activities from a quality and compliance perspective. This includes providing guidance on design control requirements and ensuring project activities and documentation comply with FDA QMSR requirements, ISO 13485, applicable risk management standards, and established internal quality procedures.
The individual will lead or support quality-related activities throughout the product development and change management lifecycle. This may include reviewing project and design documentation, evaluating proposed product or process changes, identifying potential quality and regulatory impacts, supporting design reviews, and ensuring appropriate quality documentation is completed prior to implementation.