AddressYour work experience at Incisive Technologies:
- Full time
- Melbourne – Ferntree Gully, CBD &/or WFH (tbd)
- Opportunity for growth
- Product launch imminent – global reach
Incisive Technologies has developed BlueCheck, a novel “paint” that is used in the dental clinic to identify early-stage caries, the precursor to cavities. Incisive has grown from a university-led activity to a corporate enterprise, now consisting of a small team of 15 valued staff and consultants, committed to taking BlueCheck to patients. Oral health disease is the largest most chronic widespread disease in the world. BlueCheck has the attributes to fundamentally change and improve oral healthcare. Our commitment to improved health is what unites our team.
- https://www.bluecheckdental.com/
- https://www.incisive-technologies.com/
Incisive requires an experienced Quality expert, ideally with medtech experience. They will be a senior member of the team, reporting to the CEO. They will be expected to build on and manage existing quality systems and testing within the company. This position is considered critical to the company and therefore the successful candidate will have strong management skills in overseeing staff, developing budgets, maintaining the QMS, coordinating activities with regulatory advisors and serving as the interface between the regulatory authority, medical officers, suppliers and Incisive.
The Head of Quality will be accountable for all quality aspects of product, process and systems at Incisive.
Experience - required:
- 10-15 years of experience in a quality management related role, or similar, within the bio-medical/tech, medical device or pharmaceutical industry
- Bachelor of Science or relevant scientific (STEM) tertiary qualification, or other relevant industry experience
- Demonstrated ability to make timely, informed quality decisions focused on patient safety and compliance with a balanced understanding of business impact
- Experience with building quality processes, structure and capability through organisational growth and change
- Experience with developing and maintaining a robust quality and compliance culture
- Strong, hands-on experience with driving collaborative resolution of complex technical and quality issues using effective root cause analysis and CAPA processes
- Demonstrated ability to manage stakeholders in a timely and transparent manner
- High attention to detail, strong organisational skills, and time management skills
- Proven commitment to and success in continuous improvement
Experience - desirable:
- Exposure with implementation of 21CFR 820 and/or ISO13485 requirements
- Demonstrated competence in building and developing a high-performing team
- Experience in handling regulatory inspections (FDA, TGA)
- Experience in maintenance of Quality systems, including auditing, deviations, change control, document management
- Sound analytical skills and ability to communicate complex matters to a range of audiences
- Experience in a high-paced manufacturing environment; clean room experience
- Experience of developing and delivering training programs
Specific key accountabilities will include:
- Establish the goals, objectives and implementation of the Quality program
- Ensure quality system requirements are effectively established and maintained in accordance with regulatory requirements including FDA 21CFR 820, ISO13485 & EU2017/745
- Own and manage the quality management system (QMS)
- Manage and execute batch review and release of finished products
- Oversee key quality systems as executed by responsible individuals across Incisive, including:
- Documentation control, change control, risk management, deviation, OOS and CAPA management, internal audit, supplier qualification, design verification, validation lifecycle, and training
Contributing to team development with a quality lens
- Identify professional development opportunities for self and others
- Set personal development milestones and encourage others to do so
- Be proactive in building your local, national, and international network and share those experiences with your team members
- Establish strong working relationships and trust with colleagues and third parties to foster an open and collaborative team environment
- Drive development of practices leading to an outstanding work environment
- Offer and receive constructive criticism to and from anyone at all times
If you would like to apply, please supply your CV and a cover letter which explains your interest in the role and how you meet the experience criteria above.
We thank you for your interest.
