Quality Specialist

3 weeks ago

Brisbane, Australia Brunel Full time

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

**About you**
- 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

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

**About us**
- 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._

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