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May

Qa Associate (Medical Devices)

PERSOLKELLY - Melbourne, VIC

Any Industry
Source: uWorkin

JOB DESCRIPTION

PERSOLKELLY is currently seeking an enthusiastic QA Associate with a strong experience in medical devices, to join our client's team (Multinational pharmaceutical corporation).

  • 12 month contract
  • Full-time role
  • South-East suburbs

The QA Associate role includes, but is not limited to, the following:

  • Supports QA Manager and/or delegate to administrate GMP and associated documentation for new technologies and medical device in accordance with PQS, 21CFR 820, PICs, EU 2017/745, EU MDR and relevant board of health regulations.
  • Support site inspections to maintain ISO accreditation (or equivalent) for devices and compliance for the new technologies coordinating the preparation of the site, drafting plant responses, ensuring closure of commitments to agreed timeframes.
  • Preparation and Maintenance of documentation includes, but not limited to: Quality Manual / Plan, Design History files, Risk Assessments, Change Management, Complaints, Management Review, Notifications to Management, Post Marketing Surveillance reports, Self- Assessments, Supplier Qualification / Incoming devices, Batch Records & related release activities, Stability, Specifications and other regulatory requirements for medicine products
  • Support the Quality group in relation to (but not limited to) investigations/commitments, change requests, audits ensuring these are addressed per business requirements and targets.
  • Participate in and contribute to compliance program for medical device and new technologies to ensure efficient and effective systems are in place in order to provide a sound service to internal and external customers, supporting their business needs.

Requirements:

  • A minimum Bachelor's Degree in an Engineering, Scientific or related discipline is required for this role.
  • Years of Experience: 2-3+ years in Quality function with Medical Devices.
  • ISO 13485 experience is required.
  • Well-developed written and verbal communication skills
  • Well-developed consultation and negotiation skills

If you want to know more about the role or have any questions, please reach out to Manisha on manisha.jadoo@persolkelly.com.au.

Who are we

At PERSOLKELLY, our passion is - and always has been - putting you first.

We propel our people forward by supporting their careers in fresh ways, backed by our expertise and capability.

We're committed to creating a safe and inclusive environment which values and respects diverse styles, backgrounds, experience and perspectives.

We welcome and encourage women, people of Aboriginal and Torres Strait Islander descent and people from diverse backgrounds to apply.

So it's over to you. If you would like to join our team, please APPLY now.

To learn more about working with PERSOLKELLY, we encourage you to visit our website.