Quality Engineer
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World leading medical device organization is seeking a skilled Quality Engineer to join their team.This Jobot Job is hosted by: Jeff MatheosAre you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary: $75,000 - $95,000 per yearA bit about us:We are a well-established Medical Device organization that is rapidly growing due to our innovative products. We are looking to add a skilled Quality Engineer who has experience working in FDA AND ISO facilities. If you are a Quality Engineer with 5+ years of experience working in the Medical Device Industry read on!Why join us?Competitive Pay $75-$95kGreat company cultureStabilityGrowth opportunitiesComprehensive benefits packageJob DetailsEssential Functions and Responsibilities:
- Review customer complaints, conduct product investigations and ensure proper complaint closure
- Conduct medical device reporting assessments and investigations.
- Develop sampling plans for evaluating, and reporting quality and reliability data.
- Demonstrate continuous effort to improve product quality and manufacturing processes.
- Participates on Project Team as Quality Representative. Ensures that principles of Design Control are applied to Product and Process Changes and New Product Development.
- Provides Quality Assurance leadership for Project Teams or Quality departments.
- Creates reviews and approves Quality System Documents (ex. CAPA, Audits).
- Creates reviews and approves Product Documents.
- Creates, reviews, and approves Protocols, Process and Product Validations, Stability Protocols, Software Validation documents.
- Quality Engineering and Customer Complaint Investigation experience
- Working knowledge of standards and regulations, including but not limited to US-FDA's 21 CFR Part 820 and 21 CFR Part 803, and GMP.
- Medical Device Industry experience and working knowledge of ISO-13485 and ISO 14971 Medical devices