Senior QA/RA Specialist - Medical Device (Hybrid, Zurich)

Apersys AG; Zürich; Hybrid; CHF 110,000 - 140,000; Full time

Benefits offered by this job

BV G pension

Accident & illness insurance

Family-friendly leave

Employee stock option program

Hybrid work model

Job summary

Apersys AG in Zurich, Switzerland, seeks a Senior Specialist QA/RA to drive quality system integration across ISO 13485, FDA QMSR, and EU MDR. You will support regulatory submissions in the US, Switzerland, and the EU while coordinating with Engineering and Operations on quality records and audits.

You will lead CAPAs, change control, and supplier quality activities in a small team, contributing to audits and continuous improvement. Fluency in English and Swiss work eligibility are required.

Qualifications

• Bachelor’s or Master’s degree in life sciences or engineering.
• 3+ years in QA/RA for medical devices.
• Thorough knowledge of ISO 13485, ISO 14971, FDA 21 CFR Part 820 (QMSR), and EU MDR 2017/745.

Responsibilities

• Build ISO 13485, FDA QMSR, and EU MDR requirements into the QMS; draft, review, and update SOPs, templates, and records.
• Lead and support CAPAs, deviations, nonconformities, 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.

Skills

Fluent English

Regulatory knowledge

Audit experience

Cross-functional collaboration

Problem solving

Education

Bachelor’s or Master’s degree in life sciences, engineering, or related field

Tools

Greenlight Guru

Job description

Apersys AG in Zurich, Switzerland, seeks a Senior Specialist QA/RA to drive quality system integration across ISO 13485, FDA QMSR, and EU MDR. You will support regulatory submissions in the US, Switzerland, and the EU while coordinating with Engineering and Operations on quality records and audits.

You will lead CAPAs, change control, and supplier quality activities in a small team, contributing to audits and continuous improvement. Fluency in English and Swiss work eligibility are required.