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Quality & Regulatory Manager ANZ

Sonova
Baulkham Hills, AUS
Manager
Onsite
Discovered 2 weeks ago

Full Job Posting

What We Offer

  • The opportunity to work for a global leader in hearing healthcare and medical technology.
  • A role with real influence across the ANZ business.
  • Exposure to regional and global quality and regulatory teams.
  • A collaborative and purpose-driven culture.
  • Ongoing professional development and career growth opportunities.
  • Ready to make a difference?
  • If you're passionate about quality, compliance, continuous improvement, and making a positive impact on people's lives, we'd love to hear from you.
  • Apply today and help us shape the future of hearing care across Australia and New Zealand.

Qualifications

  • We're looking for a quality professional who thrives in a regulated environment and enjoys driving meaningful improvements.
  • Essential Experience
  • Degree qualification in Engineering, Manufacturing, or a related discipline.
  • Significant experience within Quality Management, Quality Assurance, Regulatory Affairs, Medical Devices, Healthcare, or another highly regulated industry.
  • Experience working within GMP and/or medical device environments.
  • Strong knowledge of Quality Management Systems and audit processes.
  • Proven experience managing customer complaints, corrective actions, risk management, and compliance activities.
  • Excellent analytical, problem-solving, and stakeholder management skills.
  • A proactive mindset with the ability to influence and drive change across the business.
  • Highly Regarded
  • Experience with medical device regulations and standards including ISO 13485, ISO 9001, MDR, MDSAP, and FDA quality requirements.
  • Lead Auditor qualifications.
  • LEAN Six Sigma experience.
  • Experience in data analytics, statistical process control, or product quality improvement initiatives.
  • What Success Looks Like
  • Puts customers at the centre of decision-making.
  • Thinks critically and solves complex problems.
  • Plans effectively and delivers results.
  • Builds trusted relationships across teams.
  • Maintains exceptional attention to detail while balancing competing priorities.
  • Takes ownership and acts with urgency when it matters most.

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