QA/RA Associate

Sector

Manufacturing

QA


Type

Permanent / Full Time


Contact

info@onemd.com.au


Posted on

17 Nov 2021

Objective

An international IVD Company

Job Description

Our client is an international IVD organisation who designs, manufactures and markets multiplexing molecular diagnostic assays and reagents.
This company offer fantastic work life balance and an amazing work culture and there are plenty of opportunities for career development and progression within the organisation.

Position Overview:
This is a newly created role for an expanding Regulatory/Quality team and will be mentored by the Senior RA/QA Associate 

Responsibilities:
  • Conducting regular scheduled internal audits to ensure compliance to accreditation standards
  • Managing document control and approval processes for all QA/RA documentation, including SOPs
  • Advising on regulatory pathways and strategies for product submissions
  • Conducting regular internal and external analysis to ensure adherence to all global regulatory directives for legal supply of IVD products
Desired experience:
  • Minimum 1-2 years of RA/QA experience in Medical Devices or IVD's
  • IVD Manufacturing experience 
  • Degree qualified (relevant to the role) 
What's on offer:
  • Competitive Base salary + Super
  • Hybrid work from home/Office
  • Onsite meditation room and yoga room 
  • Company celebrates all cultural days
  • Clear career development opportunities 
 To apply for this role, please reach out to Nicola Davison 0472 729 731

nicola.davison@onemd.com.au

Requirements

  • Experienced in working in Medical Devices
  • Experienced in working in Manufacturing
  • Excellent work culture and career progression