Senior Quality Systems Engineer – Medical Devices / Combination Products
100% Remote
On behalf of a well funded Medtech Start-up we’re seeking an experienced Senior Quality Systems Engineer to take ownership of the Quality Management System (QMS) and ensure full compliance with global regulatory requirements. This is an end-to-end role covering design controls, manufacturing, supplier oversight, quality and compliance, and post-market surveillance.
Key Responsibilities:
* Develop, implement, and maintain ISO 13485–compliant QMS.
* Lead audits, risk management, CAPA, and management reviews.
* Oversee suppliers, CMOs/CDMOs, testing labs, and QP release activities.
* Ensure compliance with GMP, GDP, MA requirements, and regulatory inspections.
* Manage regulatory submissions, technical agreements, and product quality reviews.
* Drive continuous improvement initiatives and lead risk assessments (ISO 14971, ICH Q9).
About You:
* Degree in Pharmacy, Biomedical Engineering, Quality, or related discipline (Master’s preferred).
* 8+ years’ Quality/Compliance experience in the medical device or pharmaceutical sector.
* Strong leadership in QMS implementation (ISO 13485, ISO 14971, GMP).
* Proven background with design controls, risk management, supplier audits, and regulatory inspections (MHRA/Notified Bodies).
* Experience with combination drug/device products highly desirable.
* Eligible for or working toward QP status a plus.
The Offer:
Remote-based role with travel for audits, inspections, and supplier oversight.
Competitive package and opportunity to shape quality strategy at a senior level.
📩 Apply today to play a pivotal role in ensuring patient safety, product compliance, and successful market access.