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Director, Operations Quality Management
2 months ago
About the Opportunity
This is a pivotal role within the Healthcare Professionals Group, where you will play a key part 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.
Key Responsibilities
• 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.
Requirements
• 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.
About the Company
The Healthcare Professionals Group is a forward-thinking organization dedicated to developing advanced neuromodulation systems for implantable stimulation devices. With multiple manufacturing and distribution facilities, the company 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.
