Quality Associate – Post Market Specialist - 26812BR - EI in St Leonards at Stryker Corporation

Date Posted: 5/7/2018

Job Snapshot

Job Description

We help to change and save people’s lives through teamwork, dedication and innovative technology. We care about our customers, patients and each other which is why we are consistently recognised as a great place to work. Our continued success means we are expanding our team.

We are looking for exceptional people who truly want to make a difference…. because at Stryker we do!! Working for Australia’s #1 best place to work is rewarding. We help to change and saves people’s lives every single day. We are high achievers who know how to work hard and have fun.

As the Quality Associate – Post Market Specialist, your main objective of this role is to ensure Stryker South Pacific is in compliance with all requirements in regard to Post-Market responsibilities including, product hold, product field action and complaint activities. This role involves coordinating activities with key stakeholders across the business, particularly Quality Assurance, Marketing, Sales, Regulatory and Operations in line with the execution of PFAs, along with other interdepartmental liaisons.

Main responsibilities include:
  • Liaison with key stakeholders to ensure all aspects of product holds and field actions are managed according to local, corporate and regulatory body requirements.
  • Responsible for actioning all aspects of product hold and product field actions
  • Process regulatory actions
  • Responsible for accurate data analysis of all inventory reports for product hold and product field actions
  • Liaise with manufacturing divisions and SSP sales and technical services personnel
  • Preparation and release of regular reports associated with regulatory actions, and Post Market Surveillance
  • Identify areas for process improvement and implement actions accordingly.
  • Responsible for all necessary administrative and record keeping duties
  • Responsible for partnering with areas of business to ensure activities are in compliance with Quality System, regulatory and corporate requirements.
  • Responsibilities to ensure SSP process reflect all corporate and regulatory requirements
As the successful candidate, you will have:
  • 3+ years’ experience in the Health Industry in Regulatory Affairs and/or quality systems and standards
  • Experience in post market activity
  • Experience in implementing and maintaining quality systems
  • Experience in the development of training material & facilitation
  • Knowledge and understanding of applicable external regulatory standards
  • Advanced Excel and high proficiency with all other Microsoft Office applications
  • Analysis and interpretation of regulatory and legal documentation and technical writing
  • Strong interpersonal and project management skills, must be able to interact effectively at all levels of the company and handle confidential and sensitive information appropriately
If you want a change in pace, some excitement in your work and to feel a sense of satisfaction that you are helping make healthcare better for customers, then apply below. Or to find out more about this or any other potential role within our business, please visit https://careers.stryker.com/en-au/ to view our current vacancies.

Job Requirements

As above

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