QA Release Specialist – Medical Devices (On-Site)

Randstad Switzerland; Zürich; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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).

Aufgaben

• 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.

Kenntnisse

Quality Assurance

Quality Control

Batch release

Regulatory standards

Documentation review

Cross-functional coordination

English & German

Tools

ERP systems

eQMS

PLM

Jobbeschreibung

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.