Quality Assurance Technician (Medical Devices)

Randstad Switzerland; Zürich; On-site; CHF 110,000 - 140,000; Full time

Job summary

Randstad Switzerland is supporting a leading international healthcare company seeking a QA Operations / Release Specialist (QA Technician) for on-site work in Zurich. The role focuses on quality assurance, DHR release, and SME support during audits, collaborating with QA, QC and manufacturing teams.

Requirements include 4+ years in QA/QC or batch release within life sciences and fluency in English and German; ISO 13485, GDP and ALCOA knowledge are essential.

Qualifications

• Min. 4 years hands-on experience in Quality Assurance, Quality Control, or batch release in Medical Device, Pharmaceutical, or Biotechnology industries.
• In-depth knowledge of ISO 13485, GDP, and ALCOA data integrity principles.
• Experience reviewing batch/device documentation (DHR) and executing product release activities.
• Experience supporting shopfloor operations in on-site, highly regulated manufacturing environments.
• Strong communication, negotiation, and cross-functional coordination skills.
• Fluency in English and German (written and spoken).

Responsibilities

• Perform material and product release following SOPs and GDP.
• Review and verify DHR completeness, accuracy, and traceability.
• Act as SME during regulatory audits for quality procedures, docs, and release.
• Coordinate weekly workload planning at the shopfloor board with QC, Manufacturing and Supply Chain teams.
• Track and report release lead times using ERP and reporting tools; mitigate bottlenecks.
• Report non-conformances and support deviation handling per quality procedures.
• Lead small-scale continuous improvement projects and improve SOPs and work instructions.

Skills

Quality Assurance

Quality Control

Batch release

Regulatory standards

Documentation review

Cross-functional coordination

English & German

Tools

ERP systems

eQMS

PLM

Job description

For one of our clients, a leading international healthcare company specializing in advanced medical devices and health technologies, we are currently looking for a QA Operations / Release Specialist (QA Technician).

General Information:

• Start date: January 2027
• Contract: 12-month contract (January 2027 - December 2027)
• Home office: 100% on-site, in the manufacturing area

About the job:

In this role you will conduct quality assurance and product release activities to ensure the compliance, accuracy, and integrity of Device History Records (DHR) and medical devices in accordance with internal standards and international regulatory requirements. You will act as a key interface between QA, QC, and manufacturing operations, represent the release team, drive continuous improvement, and serve as a Subject Matter Expert during internal and external audits.

Tasks & Responsibilities:

• Perform material and product release activities following standard operating procedures and Good Documentation Practice (GDP).
• Review, maintain, and verify the completeness, accuracy, and traceability of Device History Records (DHR).
• Act as a Subject Matter Expert (SME) during regulatory audits for quality procedures, document reviews, and product release.
• Coordinate weekly workload planning and prioritization at the shopfloor board in alignment with QC, Manufacturing, and Supply Chain teams.
• Track and report release lead times using ERP/reporting tools, proactively mitigating bottlenecks in the release flow.
• Promptly report non-compliance issues and support deviation handling according to established quality procedures.
• Lead small-scale continuous improvement projects and optimize department SOPs, work instructions, and guidelines.

Your profile:

• Minimum 4 years of hands-on experience in Quality Assurance, Quality Control, or batch release within the Medical Device, Pharmaceutical, or Biotechnology industries.
• In-depth knowledge of regulatory standards, notably ISO 13485, Good Documentation Practice (GDP), and ALCOA data integrity principles.
• Solid background in reviewing batch/device documentation (DHR review) and executing product release activities.
• Practical experience supporting shopfloor operations within an on-site, highly regulated manufacturing environment.
• Strong communication, negotiation, and cross-functional coordination skills.
• Fluency in both English and German (written and spoken).

Nice to Have:

• Experience acting as an SME during external notified body or authority audits.
• Familiarity with industry-standard eQMS, PLM, and ERP systems
• Demonstrated ability to lead small process improvement initiatives or Lean/Shopfloor board management