AddressPosition:Quality and Operations Officer
Term: 6-month, Full time, with opportunities for a permanent contract afterwards.
Experience: 2-5 years, previous experience in creating ISO13485 compliant systems is highly desirable
Salary: $75,000 - $90,000 (based on experience) + 12% superannuation + benefits (see below)
Location: Flexible (Remote and on-site in Port Melbourne).
Indicative closing date: 18th July 2024
Note: We will start reviewing applications as from the 1st of July and close the job once we find the right candidate. Apply as soon as possible.
About Diag-Nose.io
We are an early-stage biotech startup on a mission to build the future of respiratory care
Our core mission is centered around a profound commitment to enhancing the lives of respiratory patients across the globe and using AI and biological tools (“omics”) to become a global leader in respiratory health.
We are building the RhinoMAP, a best-in-class precision medicine platform dedicated to helping respiratory patients worldwide find the right treatment faster. If the right treatment does not exist, we are committed to discovering and developing new drugs.
Our goal is to transform lives by ensuring that every patient, regardless of who they are or where they are from, can take a deep breath and embrace a longer, richer, life full of possibilities.
What we are looking for
We are seeking a Quality and Operations Officer to join our team. Reporting to the Senior Engineer, you will handle the Quality Management System, including procedures, document revisions, internal audits, and managing customer concerns with corrective actions. You will also play a key part in ensuring our operations meet high standards of Quality and efficiency.
Your responsibilities will be diverse and dynamic, offering a chance to make a significant impact on our organization.
What you will be spending your time on:
- 40% - Quality Management System (QMS) Development: Work with our senior engineer to establish and maintain a robust QMS in compliance with ISO 13485 standards.
- 10% - Regulatory Compliance: Manage regulatory compliance efforts, including documentation, audits, and certifications. Conduct gap analyses and implement corrective actions to industry standards.
- 40% - Operational Leadership: Support the CEO in managing the day-to-day operations of Diag-Nose.io, ensuring seamless coordination across departments.
- 10% - Process Improvement Initiatives: Collaborate with engineering, clinical, and manufacturing teams to identify opportunities for workflow efficiency, cost reduction, and product quality enhancement.
Reasons you might not like this role:
- Flexible priorities: You may need to juggle multiple tasks and adapt quickly to changing priorities, which can be challenging if you prefer a predictable routine.
- Regulatory complexity: The role involves reading and understanding the detailed, often dry language of regulatory standards, which might not appeal to everyone.
- Process-oriented work: The job requires a methodical, step-by-step approach that could feel limiting if you prefer creative problem-solving or spontaneous decision-making.
- High autonomy: You will be entrusted with significant autonomy in your projects from the start, which can be challenging if you're not comfortable taking initiative and working independently early in your career.
- Fast-paced environment: Our project timelines are aggressive, requiring quick adaptation and swift action, which might not suit everyone's working style
About You
- You speak our language: You have a degree in engineering or a related field and some experience with medical device quality management systems.
- Experience with rigorous protocols: You are adept at ensuring compliance with complex quality procedures and regulatory requirements.
- Clear communicator: You convey information clearly to various stakeholders, from clinical staff to fellow engineers, making sure everyone understands the goals and progress of our projects.
- Detail-oriented: Your focus is on ensuring precision in every aspect of our operations and processes to meet the high standards for clinical use.
Perks & Benefits
- Equity package: Everyone who joins our team receives a slice of the company, because we invest as much in you as we do in our mission.
- Extra leave days: Take advantage of extra time off to recharge and manage life's important matters.
- Learning stipend: Boost your skills and career with an annual stipend for courses, conferences, or whatever helps you grow.
- Flexible working hours: Find your perfect balance with flexible working hours, whether that’s remote or in our Port Melbourne office.
- Competitive salary: Earn a competitive salary that reflects your skills and contributions.
Why You Should Join Diag-Nose.io
Joining Diag-Nose.io means collaborating with a dedicated team to tackle significant challenges in respiratory health. You'll have the opportunity to make a substantial impact on our research and development efforts, contributing to advancements that will benefit patients worldwide.
Diversity at Diag-Nose.io
At Diag-Nose.io, we're dedicated to breaking down barriers in healthcare access, ensuring that cutting-edge respiratory treatments reach every patient, regardless of their background or location. Our mission is driven by a commitment to diversity and inclusion, recognizing their importance in innovating and providing equitable healthcare solutions globally.
We try our best, and while we might not always get it right, our employees and community, are always our top priority, as we work towards a future where everyone enjoys a healthier life.
How to Apply
If you believe you are the candidate we're looking for, please send your resume and a cover letter (2 page max) to ****@diag-nose.io or apply through SEEK.
Your cover letter needs to address the following questions:
- What interests you in joining an early stage startup like Diag-Nose.io?
- What experience do you have with an ISO 13485 compliant quality management system?
- Can you give an example of a process improvement you led successfully?
