Quality and regulatory leadership, from global manufacturers to start-ups.
I'm Dave Tiernan, founder of Bespoke Quality Solutions and a BSI-trained ISO 13485 Lead Auditor. Over 15 years with Boston Scientific, Trinity Biotech, Mylan, Johnson & Johnson, 360MedCare and Enovis, I've led quality, regulatory, integration and market access work in medical devices, pharmaceuticals and diagnostics. I now bring that experience to start-ups, multinationals and universities.
Where I've worked
Bespoke Quality Solutions, 2024–present. Founder and Principal Consultant. ISO 13485 scope extensions, TGA audit preparation, health hazard evaluations and field safety corrective actions for clients in medical devices, electronics, aerospace and defence, NDIS and aged care.
Enovis, 2023–2025. Four concurrent roles after Enovis acquired 360MedCare: ANZ RA/QA Manager, Market Access Manager, Manufacturing Operations RA/QA Manager and Integration Project Manager. Led a successful onsite TGA inspection, Class III implant submissions through to Prescribed List inclusion for the EMPOWR 3D knee, and consolidated four businesses into one site.
Ellen Medical Devices, 2022–2023. Engineering Manager for a portable peritoneal dialysis system.
360MedCare, 2018–2023. Quality Assurance Manager, then RA/QA and Manufacturing Operations Manager. Took the company to MDSAP certification for Australia and the US, and hosted BSI audits covering ISO 13485, MDSAP and EU MDR.
Johnson & Johnson Medical, 2017–2018. Quality assurance for new product introductions and market access across device franchises.
Mylan Respiratory, Dublin, 2014–2016. Senior Manufacturing Technologist and team lead under GMP. Halved one production line's changeover time, from 16 hours to 8.
Trinity Biotech, 2011–2014. Product Biochemist manufacturing in vitro diagnostic HIV test kits in an FDA-regulated GMP environment.
Boston Scientific, 2009. Biocompatibility and Toxicology Specialist. ISO 10993 assessments and contracted testing.
Qualifications: BSc (Hons) Biomedical and Advanced Materials, University of Limerick · BSI ISO 13485:2016 Lead Auditor · ARCS Senior Industry Leadership Program
What I believe about quality
Fit the system to the business.
A five-person start-up needs a QMS built for five people. I'll show you the smallest system that passes audit and still helps you run the business.
Your team should own it.
I coach while I build, so your people understand the why. When I step back, the system keeps working.
Stay calm at audit.
I've hosted the TGA and sat through an NDIS audit. Good preparation turns audit day into a conversation.
Who I work with
Start-ups
Founders building their first device or regulated product. A QMS sized for a small team, a team coached to run it, and a clear path to certification and approval.
Multinationals
Global manufacturers entering or growing in Australia and New Zealand. Interim RA/QA leadership, local sponsor set-up, integrations, site moves and TGA audits.
Universities and research institutes
Research teams turning discoveries into products. Design controls, risk management and the quality evidence that partners, investors and regulators expect.
Book 20 minutes.
Tell me where you are and where you need to get to. If I'm not the right fit, I'll tell you who is.
Dave Tiernan · Noosa Heads, QLD
0420 548 781 · info@bespokeqs.com · LinkedIn