Benefits • Opportunity to join a reputable medical device and pharmaceutical manufacturer with exposure to FDA, TGA and European Notified Bodies.• Collaborative, respectful, and innovative company environment.• Competitive Salary Package.• Career progression opportunities.• Onsite Parking.About the company With over 30 years' experience in research and design, this medical device company brings an innovative and niche product to the healthcare industry.The Sydney-based device company is driven by enhancing and developing medical innovations for diagnostic imaging, specialising in lung health.This is an exciting time to join the organisation as they have obtained new market share and enhanced products.About the opportunity As the Head of Quality, you will be required to oversee the Quality and Regulatory department onsite daily.Your responsibilities will include managing quality systems, ensuring audit-readiness, maintaining accurate records and reporting, and promptly closing out any CAPA or audit findings.To excel in this role, you must possess strong leadership experience, comprehensive knowledge of medical device ISO regulations and pharmaceutical regulatory guidelines, as well as excellent planning, influencing, and interpersonal skills.Duties • Maintaining and updating quality system requirements in compliance with regulatory standards.• Reporting data metrics on the quality system to executive management.• Ensuring all necessary testing is conducted in a timely manner.• Oversight of regulatory compliance, including Internal and External Audits.• Implementing a Risk Management Program and supervising customer complaints.• Approving procedures and documents related to Preventive Maintenance, Calibration, Validation, and Qualification.• Maintaining out-of-specification, deviation, out-of-trend, change control, nonconformance, and stability programs.**Please note, the ideal candidate is locally available and has unrestricted working rights in Australia.Skills and Experience • Tertiary qualification in a Science, Engineering, or related field • Minimum 10 years of Quality Assurance experience in a GMP-certified medical device or pharmaceutical setting, ideally encompassing both areas.• Minimum 7 years of QA management experience.• Experience in FDA, TGA, and ISO13485 auditing is a must.• Strong written and verbal communication skills.• Great organizational, influencing, and problem-solving skills.• Demonstrated capacity to effectively lead, direct, and mentor a team.Culture This company has a collaborative team environment valuing integrity, innovation, and quality whilst manufacturing and developing innovative technologies.How to Apply Click apply or email Tamara El Husseini, Recruitment Consultant on ****** for a confidential discussion.
