Skip to main content
Post your resume and find your next job on Indeed!

Risk Management Medical Device jobs

Sort by: -
    • Your education must be in a discipline relevant to medical device manufacture and use and contain modules relating to implantable devices.
    • View all BSI jobs - Australia jobs - Auditor jobs in Australia
    • Salary Search: Medical Device Auditor ISO13485(home based) salaries in Australia
    • See popular questions & answers about BSI
    • Strong understanding of medical device technical documentation, manufacturing processes and quality management systems.
    • Education Level Bachelor's Degree.
    • Educate stakeholders on risk responsibilities and promote a strong risk culture.
    • Coordinate and document incident investigations, capturing key data in the risk…
    • Significant experience in infection prevention and reusable medical device reprocessing.
    • Lead quality improvement and risk management initiatives relating to…
    • Facilitate ongoing implementation and monitoring of the Hospital/Facility wide quality improvement program and to promote risk management to support the…
    • Appropriate clinical knowledge and experience required, such as exposure to medical and surgical procedures and the use of medical devices in a clinical setting…
    • Strong understanding of enterprise risk management, compliance obligations and prudential regulatory requirements.
    • Demonstrated experience applying risk management frameworks, policies, and principles.
    • You will help the business understand and manage risk within appetite,…
    • Generate scientific and CMC insights that support development milestones, regulatory submissions and lifecycle management activities.
    • Communicates potential new business leads to PC management and account managers.
    • Ensures that appropriate risk identification and issue-escalation procedures…
    • Experience in clinical program management, clinical development strategy and study design/trial management and reporting within the medical device or…
  • View similar jobs with this employer
    • Experience supporting incident investigations and risk management processes will be highly regarded.
    • Lead the organisation's clinical governance, quality and…
    • OPIS is an International CRO with 25 years of experience in conducting Phase I-IV, non-interventional and medical devices studies on an international level.
    • Experience using risk and incident management systems (e.g. RiskMan or equivalent).
    • Demonstrated experience in quality, risk management and patient safety…
    • Support risk management activities, including risk assessments, hazard identification, risk analysis, and maintenance of risk management documentation in…

Job Post Details

Medical Device Auditor ISO13485(home based) - job post

BSI
3.5 out of 5 stars
Australia
You must create an Indeed account before continuing to the company website to apply

Location

Australia

Full job description

We exist to create positive change for people and the planet. Join us and make a difference too!

Auditor – Medical Devices

Location – New South Wales Australia (homebased)


Are you looking for a career where you can use your expertise to ensure patient safety?


Do you want variety and exposure to different medical device manufacturers and cultures?


Your next career could be as an auditor; or as we call them at BSI a Client Manager.


Our team in APAC are looking for medical device professionals who can demonstrate their expertise with design and/or manufacture or servicing of animal tissues in Medical Devices.


What will I do?

  • Firstly, you’ll undertake extensive training to deliver in your role. This includes: ISO13485 Lead Auditor course, MDSAP (Medical Device Single Audit Programme), and MDR (Medical Device Regulation).
  • Then as a Client Manager you’ll be responsible for frequently travelling across New Zealand and Australia and some International travel might be required.
  • You’ll assess ISO13485 quality management systems and associated medical device regulatory requirements on customer sites or sometimes remotely, write up comprehensive reports and present these to the client.


To be a successful Auditor you’ll:

  • Be degree educated (Bioscience or Biotechnology degree, Masters or equivalent qualifications)
  • Your education must be in a discipline relevant to medical device manufacture and use and contain modules relating to implantable devices.
  • Have a minimum of 5 years being directly responsible of either the design and development or research and development, of an array of different medical devices.
  • Strong background in in-vitro diagnostic medical devices, including both reagents and instruments, and their interfaces (experience can be - research, design and development, manufacturing, or testing).
  • Local hire only.

About Us

BSI is a business improvement and standards company and for over a century BSI has been recognized for having a positive impact on organizations and society, building trust and enhancing lives.

Today BSI partners with more than 77,500 clients in 195 countries and engages with a 15,000 strong global community of experts, industry and consumer groups, organizations and governments.
Utilizing its extensive expertise in key industry sectors - including automotive, aerospace, built environment, food and retail, and healthcare - BSI delivers on its purpose by helping its clients fulfil theirs.
Living by our core values of Client-Centricity, Agility, and Collaboration, BSI provides organizations with the confidence to grow by partnering with them to tackle society’s critical issues – from climate change to building trust in digital transformation and everything in between - to accelerate progress towards a better society and a sustainable world.

BSI is an Equal Opportunity Employer dedicated to fostering a diverse and inclusive workplace.

Let Employers Find YouUpload Your Resume