Senior Specialist RA/QA (ID125)

Senior Specialist QA/RA

Zurich, Switzerland · Full-time 100% · Hybrid · Quality & Regulatory

Join our two-person Quality Assurance and Regulatory Affairs team, reporting to the Head of QA/RA. You will work across quality assurance, regulatory affairs, and operational quality: building ISO 13485, FDA QMSR, and EU MDR requirements into our quality management system, supporting submissions in the US, Switzerland, and the EU, and making sure the records behind every build hold up in an audit. You will work day-to-day with Engineering, Clinical Affairs, and Operations at The Gallery (Glattbrugg-Opfikon).

What you will do

• Build ISO 13485, FDA QMSR, and EU MDR requirements into our existing QMS: draft, review, and update SOPs, work instructions, templates, and records.

• Lead and support CAPAs, and take part in deviation, nonconformity, and change-control processes.

• Support and participate in internal and external quality audits.

• Run supplier quality activities, including supplier evaluation and qualification.

• Support regulatory submissions and registrations in the US, Switzerland, and the EU.

• Assess the regulatory impact of product and process changes.

• Participate in product and process risk management, design reviews, and documentation reviews.

• Review and verify quality control reports and records: check completeness and compliance with internal requirements, and identify deviations and nonconformities.

What success looks like in your first year

• You run the day-to-day QMS work: document control, CAPAs, deviations, and change control. Our supplier files are audit-ready. You have contributed to our US and EU regulatory submissions and taken part in at least one internal or external audit.