Benefits
• Hybrid Flexibility.
• Free onsite Parking.
• 5-mins walk from new metro/ public transport.
• Parental Leave policy
• Team bonding activities and functions.
• Learning and development opportunities.

About the company
This organization is a forward-thinking start-up dedicated to developing advanced neuromodulation systems for implantable stimulation devices. With multiple manufacturing and distribution facilities in Sydney, it has experienced significant growth over the past five years, particularly after receiving FDA approval. The company is expanding its presence in various markets and continues to innovate in the field of medical technology.

About the opportunity
As the Director of Operations Quality, you'll play a pivotal role in shaping and maintaining the company's quality culture across all sites. Reporting directly to the VP of Quality Assurance, you will champion quality initiatives, ensuring that every product meets the highest standards and complies with both local and global regulations. You'll engage and lead internal teams and external partners, support design assurance activities, and drive continuous improvement. To thrive in this role, you’ll need to have proven leadership skills, a deep understanding of medical device manufacturing and ISO regulations, and exceptional 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.
• Leading, mentoring, and guiding the quality team and supporting cross-functional departments as required.
• Ensuring all necessary testing is conducted in a timely manner.
• Oversight of regulatory compliance, including Internal, Supplier, and External Audits.
• Implementing a Risk Management Program and supervising customer complaints.
• Approving engineering changes to maintain DMR/DHR for all products manufactured in Australia.
• Maintaining out-of-specification, deviation, out-of-trend, change control, nonconformance activities.
• Leading quality initiatives and improvements projects across sites.

**Please note, the ideal candidate has Australian experience, based in Sydney and has unrestricted working rights in Australia.

Skills and Experience
• Tertiary qualification in a Science, Engineering, or related field.
• Must have minimum 10 years of Quality Assurance experience in a GMP-certified medical device organization.
• Minimum 7 years of QA management experience.
• Experience with FDA, TGA, and ISO13485.
• Strong written and verbal communication skills.
• Great organizational, influencing, and problem-solving skills.
• Demonstrated capacity to effectively lead, direct, and mentor a team.


Culture
A supportive and collaborative atmosphere where team members work closely together.

How to Apply
Click apply or email Tamara El Husseini, Recruitment Consultant on telhusseini@hpgconnect.com for a confidential discussion.