World leading medical device organization is seeking a skilled Quality Engineer to join their team.
This Jobot Job is hosted by: Jeff Matheos Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume. Salary: $75,000 - $95,000 per year
A 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-$95k Great company culture Stability Growth opportunities Comprehensive benefits package
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.
Work Experience Requirements:
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
Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.
