Quality Specialist

Vacancy number • PUB407393

Quality Specialist

  • Brisbane
  • Closes April 25
  • 37.5 hours
  • Professional Bachelor

Start applying immediately

About this job

  • Market: Life Sciences & Health Care
  • Industry: Medical devices
  • Area of expertise: Quality Assurance & Control
  • Location: Brisbane

What is required?

  • Hours per week: 37.5
  • Education level: Professional Bachelor
  • Closing date: Thursday, April 25, 2024

Introduction

Brunel is currently partnered with a innovative medtech startup, based in the heart of Brisbane. This company has gone from strength to strength since it’s conception and has thrived off the foundation of industry experts. They are now searching for an additional Quality Specialist to assist with their portfolio expansion, following their partnership with a well-renowned global distributor. If you would like to be at the centre of innovation please see the role below:

About this role

  • Administration & Oversight: Manage QMS processes including deviations, non-conformance reporting, CAPA, change management, supplier qualifications, validation, and risk management
  • Regulatory Compliance: Ensure compliance with MDR (2020), ISO 13485, FDA's 21 CFR Part 820, and other relevant standards
  • Quality Assurance: Monitor manufacturing performance, batch reviews, and post-market surveillance
  • Support & Collaboration: Provide guidance for design, development, and product launch, collaborate with suppliers, and support continuous improvement
  • Documentation & Training: Establish and update procedures, approve documentation, and conduct staff training
  • Vendor Management: Qualify new vendors, maintain agreements, and review vendor performance
  • Regulatory Support: Assist with lifecycle management of medical devices and maintain regulatory compliance
  • Audit & Accreditation: Support internal audits, participate in audit activities, and maintain ISO accreditation and regulatory approvals

What you need to bring:

  • Min 3 years’ experience in a QA role
  • Knowledge of cGMP, QMS, GXP and regulatory guidance’s to comply with regulatory bodies (FDA, TGA, EMEA)
  • Experience with ISO 9001, ISO 13485, 21 CFR Part 820 and MDSAP
  • Bachelor’s Degree and / or experience working in QA within medical devices, pharmaceuticals or another highly regulated industry
  • Manufacturing, third party or supplier management experience
  • Able to work independently
  • Strong relationship building experience
  • Experience with implants or orthopaedics desired

Benefits:

  • Opportunity to work in a fast-paced environment
  • Great team culture
  • Wage dependent on experience (approx.100,000)

Anything Else?


Operating locally since 1997, Brunel has major bases of operation in Perth, NSW, Brisbane and Port Moresby, which are further backed by the strength and reach of a truly global network spanning over 45 countries, 120 offices and 45 years of successful operation.

Are you ready for the next step in your career? Join Brunel’s powerful global network, where passionate, results-driven specialists come together with industry-leading clients. By connecting specialists to pioneering projects, we drive change in many industries, enabling growth and delivering great outcomes. Brunel helps you reach your full potential and empowers you to make an impact within a purpose-driven global company.
Explore your career opportunities!

At Brunel, we are proud of our unique corporate culture, which is shaped and nurtured by the collective efforts of our employees. Our work environment is characterised by an authentic, communicative and inclusive approach to teamwork that fosters an atmosphere of collaboration and creativity. Our values are at the center of everything we do – for our clients, our colleagues and ourselves.

Learn more about our global network of specialists!

Since 1975, our mission has always been to connect specialists to exciting career opportunities, to support the development of these careers, and to offer fair and equal employment. This has enabled us to create a truly sustainable and durable business model. Having a passion for people and caring deeply for the environment is not only part of Brunel’s DNA but is also reflected in our culture and values. As a global company, we take our social responsibility very seriously.
Join us on our mission!

Start applying immediately

image Apply now Sending an application is quick and easy. Just make sure you have the required documents ready to go.

Any questions remaining?

Your consultant, Louise Cleland is happy to clarify anything about this vacancy. When reaching out, use this number: PUB407393

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