Contract Opportunity: Quality Systems Consultant (Medical Devices) Daily Rate: €350 – €450
We’re hiring an experienced Quality Systems Consultant to join an innovative medical devices company on a 6-month contract.
Overview
This is a high-impact, flexible role where you’ll contribute directly to improving lives through cutting-edge medical technology.
Why You’ll Love This Role
* Make a real impact, improving lives through innovative medical technology
* Flexible working – mostly remote with minimal onsite requirements
* Collaborate with a passionate, cross-functional team
* Shape strategy and influence high-level decisions
* Be part of a fast-paced, purpose-driven environment
The Role
* Shape and maintain the company’s Quality Management System (QMS)
* Drive regulatory strategy for current and future medical device products
* Support product development, market access, and global regulatory excellence
* Act as a bridge between compliance and innovation
Key Responsibilities
* Own and evolve the QMS (ISO 13485, FDA QSR, MDR)
* Lead internal/external audits, including Notified Body inspections
* Drive risk management in line with ISO 14971
* Ensure compliance across design controls, CAPA, supplier quality & PMS
* Promote a quality-first mindset via training & continuous improvement
* Manage MDR Technical Files and other regulatory submissions
* Support clinical and post-market regulatory activities
* Monitor/respond to regulatory changes impacting business strategy
Your Background
* Bachelor’s/Master’s in Engineering, Life Sciences, or related field
* 8+ years in Quality/Regulatory roles within medical devices
* Deep knowledge of ISO 13485, FDA QSR, MDR, and global submissions
* Proven track record in building or scaling QMS in growth settings
Contact Declan Ferrao on +353 1902 6802 or send your CV to declan.ferrao@archer.ie
#J-18808-Ljbffr