Full time, part time or reduced hours considered.
Level and title flexible depending on experience.
About Us
Remagine Labs is a MedTech startup developing wearable electro-pharmaceutical drug delivery devices for chronic conditions, including epilepsy.
Our patch combines a hydrogel drug reservoir, integrated electronics and controlled iontophoretic delivery.
We are backed by a licence and development partnership with a global biopharmaceutical company.
Our first clinical manufacturing campaign and Phase 1 study are ahead of us.
About the Role
Take our quality management system from early implementation to clinical-stage readiness, and own it from there.
Our electronic QMS platform is selected and initial configuration is underway.
You will assess what is in place, complete the build, author the procedures, and get us audit-ready across both the device and drug sides of a combination product.
This is a hands-on role reporting to the CEO.
We are open on level.You may set quality strategy and execute it outright, or run the system day to day with strategy and regulatory interpretation from our retained quality consultant.
Tell us in your application which of these you are and we will scope the role, title and package accordingly.
Key Responsibilities
Complete configuration and validation of our electronic QMS, and establish document, change and training control that sticks across the team
Author the core procedures: document control, change control, CAPA, deviations, supplier quality
Own the quality framework across device and drug elements, aligned to ISO *****, FDA QMSR and cGMP
Maintain design controls and the design history file through design freeze
Establish GMP documentation for the drug product: master batch records, specifications, batch review and release




Support qualification of the clinical manufacturing suite and give quality oversight of the Phase 1 campaign
Qualify suppliers and contract manufacturers, and own the quality agreements
Run internal audits and prepare us for inspection
Qualifications and Experience
Essential
Tertiary qualification in a scientific, engineering or technical discipline
3+ years in quality roles within regulated medical device or pharmaceutical manufacturing
Hands-on experience with an electronic QMS, including document control, change control and training records
Working knowledge of ISO ***** and FDA QMSR, or of pharmaceutical GMP (21 CFR ******* or the PIC/S Guide to GMP)
Willing to write procedures and records yourself, in a small team with no one below you to delegate to
Full working rights in Australia
Highly desirable
Drug-device combination product experience, including familiarity with 21 CFR Part 4
A product taken through FDA clearance or approval, or TGA registration
Electronic QMS implementation or migration, including system validation
Startup experience, clinical-phase manufacture of investigational product, or transdermal and wearable experience
How You Work
You come with a recommendation rather than a menu of options, close items out rather than leaving them open, and take work off the technical team rather than adding to it.
You know the difference between what a Phase 1 startup must have and what a commercial-stage manufacturer needs, and you do not gold-plate.
What We Offer
A quality system in its earliest stages and the mandate to own it.
Strategic backup from an experienced quality consultant, so you are not carrying the regulatory judgement alone.
A direct line to the CEO, exposure across device engineering, formulation and clinical programmes, equity participation and versatile hybrid working.
Remagine Labs is an equal opportunity employer.
We celebrate diversity and are committed to creating an inclusive environment for all team members.
#J-*****-Ljbffr

📌 Quality Systems Manager (Melbourne)
🏢 Remagine Labs
📍 Melbourne