- Contract Opportunity for an experienced Quality Leader to drive continuous improvement
- Medical Device Company located close to Melbourne CBD
- 12-week project (with potential to extend)
Our client is an ISO 9001 certified technology solutions and compliance consulting services company with global capabilities deliverable throughout the entire product quality life cycle, servicing the pharmaceutical, medical device, biotechnology and animal health industries.
The Quality Director will be responsible for overseeing the company’s quality management system (QMS) and ensuring compliance with FDA regulations, ISO 13485, and other applicable standards for medical devices. This role involves strategic leadership in maintaining product quality, driving continuous improvement initiatives, and ensuring regulatory readiness for the U.S. market.
Key Responsibilities:
Regulatory Compliance & Quality Systems
- Maintain and enhance the QMS to ensure compliance with FDA 21 CFR Part 820, ISO 13485, and applicable U.S. regulations.
- Lead audits, including FDA inspections, Notified Body assessments, and internal/external audits, ensuring adherence to regulatory requirements.
- Oversee quality documentation, risk management (ISO 14971), and validation activities for manufacturing processes.
- Develop and implement quality strategies aligned with business objectives to support market expansion and customer satisfaction.
- Lead a team of quality professionals, providing mentorship, training, and development opportunities.
- Collaborate with cross-functional teams to support design controls, supplier quality, and complaint handling processes.
- Drive continuous improvement initiatives using Six Sigma, Lean methodologies, or other quality principles.
- Lead corrective and preventive action (CAPA) investigations to address non-conformities and enhance product reliability.
- Establish key performance indicators (KPIs) to monitor and optimize quality processes.
Qualifications & Experience:
- Bachelor's or Master’s degree in Engineering, Quality, Regulatory Affairs, or related field.
- 10+ years of experience in quality management within the medical device industry, including leadership roles.
- Strong knowledge of FDA regulations, ISO 13485, ISO 14971, and other applicable standards.
- Proven experience managing audits, inspections, and regulatory interactions.
- Expertise in risk management, validation processes, and quality improvement methodologies
- Excellent leadership, communication, and problem-solving skills.
To submit your application in strict confidence, click the 'apply' button. If you require further information, please contact Voula Triantafillou on 0437 853 201.