Director of Quality Operations

3 hours ago


Macquarie Park, Australia Healthcare Professionals Group Full time
{"title": "Director of Quality Operations", "content": "About the Opportunity

We are seeking a highly experienced Director of Quality Operations to join our team at Healthcare Professionals Group. As a key member of our leadership team, you will play a pivotal role in shaping and maintaining our 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 will engage and lead internal teams and external partners, support design assurance activities, and drive continuous improvement.

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.
  • 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.

We offer a supportive and collaborative atmosphere where team members work closely together. If you are a motivated and experienced professional looking for a new challenge, please click apply or email Tamara El Husseini, Recruitment Consultant, for a confidential discussion.", "keywords": "Director of Quality Operations, Quality Assurance Manager, Operations Quality Lead, Quality Systems Manager, Regulatory Compliance Officer"}



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