Senior Quality Specialist - Medical Devices
Senior Quality Specialist - Medical Devices
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Job Description
Our Story
4DMedical is a global medical technology company aiming to change the outcomes for patients with lung disease by revolutionising respiratory imaging and ventilation analysis. Our vision is a world in which people with lung disease have better health outcomes.
We are listed on the ASX and we are currently in a highgrowth stage of the business.
What can you expect as a Senior Quality Specialist
As a key member of our high achieving Quality Assurance team this role will primarily be responsible for the for the development maintenance and improvement of the companys quality management system (QMS). You shall encourage and advocate the delivery of quality products to our customers. The Senior Quality Specialist will actively build their own product and standards knowledge and act as a mentor and advisor on quality and compliance topics to their 4DMedical colleagues with respect to compliance of premarket and postmarket medical device requirements to applicable Australian and International standards. This role will also actively support internal stakeholders (such as product teams) and external stakeholders (such as regulatory authorities) and ensure processes are in place so that the QMS technical and regulatory documentation are kept up to date.
The position does not have direct reports.
The role will include but is not limited to:
- Contributions to support 4DMedical to meet quality objectives.
- Ensuring that required QMS processes are documented.
- Ensuring the QMS contains adequate content to support 4DMedicals compliance to relevant Medical Device regulations standards requirements and guidelines for US (FDA) Australia (TGA) New Zealand (Medsafe) Canada (Health Canada) Europe (EMA) China (CFDA) and other geographies as required.
- Preparation for and participation in audits conducted to allow MDSAP notified body TGA and other certifying authority certification/licensing.
- Reporting to on the effectiveness of the QMS and any areas for improvement.
- Maintaining and improving 4DMedicals Quality Management System including transition activities.
- Primary contact for nonconformances CAPAs product complaints and post market feedback including processing of documentation.
- Authoring reviewing approving and processing QMS documents and Change Controls.
- Supporting the internal audit program.
- Mentoring and training QA and other team members as requested in all aspects of QMS and quality assurance requirements relevant to 4DMedicals business.
- Working with 4DMedical staff to write and develop documentation and develop processes required by the quality management system.
- Other Quality Activities as needed and requested by the business via the R&Q Management.
Qualifications & Industry experience requirement: - Demonstrated experience working in a regulated environment at least 5 years in a or quality process capacity related to the medical device (e.g. Class III experience).
- Competent with ISO 13485 &/or FDA 21 CFR 820 regulations. A working knowledge of ISO 14971 & other quality standards related to the essential principles/requirements is ideal.
- Experience in audit Quality Management Systems with ISO 13845 at a minimum.
- Experienced in the management of compliance activities & demonstrated ability to remediate challenges in a timely manner.
- Ability to work with complex technical documentation write effective processes & competently utilise work applications (e.g. MS Word MS Excel etc)
- Tertiary qualified preferably in a sciencerelated discipline (e.g. science engineering etc
This is a fantastic opportunity for anyone who enjoys working in a fast paced friendly and collaborative environment.
What can we offer you
- Hybrid working when in the officeenjoyour amazing new office space which includes end of trip facilities and great local coffee and eateries!
- Easy access to Public Transport and very close to Lygon St and the CBD
- Frequent inhouse presentations on all aspects of Lung Health & Technology.
- Bonus annual leave scheme as well as company paid Parental leave.
- Be a part of our Wellness program including free fruit table tennis free gym and corporate class pass Employee Assistance Program for you and your familyfree annual healthfree skin check & free flu shot.
- Rewards and Recognition Program including discounts for shopping and goods.
- Laptop and accessories provided for remote work
- Regular social events
An opportunity for you to grow in a friendly and supportive culture
How to Apply
Please apply via this link and submit a current CV and a cover letter that details your alignment with the requirements of the role.
4DMedical provides an inclusive work environment and embraces the diverse talent of its people.
For more company information visit our website:
Should you have any queries regarding the position please contact the 4DMedical Recruitment Team at:
Required Experience:
Senior IC
Employment Type
Full-Time
