Quality Engineer

Quality Engineer

03 Nov 2023
New York, Melville, 11747 Melville USA

Quality Engineer

Vacancy expired!

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
Growth opportunities
Comprehensive benefits package

Job Details

Essential 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.

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.

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