Quality System Associate/specialist

1 week ago

Macquarie Park, Australia Medtronic Full time
**Careers that Change Lives
**Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.

**A Day in the Life
**As an Associate or Quality Systems Specialist (depending on the experience), you will be supporting ANZ Medtronic Quality Management System (QMS). At Medtronic, we are committed to quality and a continuous improvement culture. This role will provide you with an opportunity to work on quality assurance projects with different OUs within Medtronic that will help foster and maintain our excellence and quality culture.

Reporting to the Quality Systems manager, the role requires close collaboration with internal stakeholders to execute Quality System processes.

This position requires continued development towards in-depth knowledge of Quality System set-up and execution, as well as progress towards exhibiting Quality leadership in the wider organization to maintain ISO 13485 compliance.


In this role, you will:

  • Support internal stakeholders as a Subject Matter Expert (SME) on the Document Control process to promote compliance and efficiency.
  • Support and lead investigation of quality issues through the use of structured problemsolving approaches like DMAIC.
  • Exhibit QMS knowledge to become a trusted business partner to our operating units by supporting strategic business needs and ensuring adherence to quality requirements.
  • Identify and drive continuous improvement of core processes.
  • Govern the selection of new suppliers and maintain existing suppliers to the Approved Supplier List (ASL) as per Medtronic policies and ISO requirements.
  • Lead projects that support the Operating Units and the effectiveness of the Quality Management System. Develop systems, processes, and KPI metrics to ensure the effectiveness of QMS.

Must Have:
Minimum Requirements

  • A Bachelor of Engineering Degree
  • 15 years of experience working within a certified Quality System (ISO 13485 or similar standard) or medical device industry
  • Good communication skills, both verbal and written and problemsolving skill
  • Computer literacy including strong knowledge of MS Word, Excel & PowerPoint and Office 360 Ability to work independently as well as within a team with a strong Can-Do attitude.

Nice to Have

  • Proven ability to create and maintain QMS technical documentation.
  • DMAIC certification/ Knowledge and experience in areas of Lean Manufacturing and Six Sigma
  • ISO 13485 std/GMP experience Strong interpersonal, organizational and project management skills
**Our Offer
**In our 5th Tenet of our Mission, we recognize the personal worth of employees by providing an employment framework that allows personal satisfaction in work accomplished, security, advancement opportunity, and means to share in the company's success.


We believe in rewarding our staff with a complete package of benefits designed to support them at every career and life stage.

As a result, our employees have access to the following benefits, to name a few:

  • Health and Wellness allowance to contribute to your general wellbeing.
  • Range of ondemand online health and wellness training resources, apps, videos, and communities
  • We invest in professional training and development for employees at all levels.
  • Our Employee Resource Groups (ERG)
- foster awareness and inclusion in the workplace.

  • Various insurance benefits include life and disability, salary continuances, salary sacrifice and KiwiSaver. We have generous employee referral programs, corporate discount programs, leave benefits, and more
**About Medtronic
**Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health, and extend Life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

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