Quality Engineer Product Safety and Compliance
Quality Engineer Product Safety and Compliance ( Linwood, PA)
To ensure the safety/compliance of products and services and their compliance to all applicable safety/compliance laws, standards and regulations, during the full product lifecycle.
Your role:
- Evaluates and investigates complaints.
- Produces and completes Safety/Compliance Engineering documents.
- Responsible for performing timely, detailed safety/compliance engineering tasks like: assessing safety/compliance of designs, reviewing tests and other performance data, analyses market feedback, completing or assisting in root cause analysis and safety/compliance problem solving.
You're the right fit if:
- You’ve acquired 3+ years of experience in a medical device
- Your skills include Basic understanding of Corrective Action Preventative Action (CAPA), as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001.
- You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .
- You have a bachelor’s degree in bio medical engineering, healthcare, nursing or related technical degree
How we work together
(This is an onsite role.)
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.
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The pay range for this position in (Linwood, Pennsylvania) is $83,000 to $143,000
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US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
within commuting distance to Linwood, PA.