Senior Supplier Quality Engineer – Med Device, GMP

HCLTech; Zürich; On-site; CHF 90,000 - 130,000; Full time

Job summary

HCLTech Switzerland is seeking an experienced Supplier Quality Engineer to join the Quality team in a highly regulated environment. You will ensure compliance, drive quality excellence, and support NPI, transfers, supplier development and process improvements across service centers.

You will lead quality initiatives, collaborate with regulatory and customer teams, track KPIs, close NCs/CAPAs, and mentor regional quality coordinators as needed. A strong background in ISO 13485 and GMP is required.

Qualifications

• Bachelor's degree in Engineering, Science, Quality Management or related field.
• Minimum 5 years in a senior Quality Engineering/QA role in regulated environments.
• Lead Assessor qualification in ISO 13485, QSR or equivalent required.
• Strong knowledge of ISO 13485, GMP, QSR, SPC, APQP and product validation.
• Experience with NC/CAPA management, investigations and risk assessment.

Responsibilities

• Act as primary quality representative for service centers on quality and regulatory initiatives.
• Lead supplier quality improvement and continuous process optimization projects.
• Coordinate CAPAs, NCs and audits with cross-functional teams.
• Support NPI activities and product transfers between sites.
• Monitor KPIs and drive data-driven improvements.
• Deliver training on quality systems and process changes.

Skills

Quality systems

CAPA management

Root cause analysis

NPI support

Cross-functional collaboration

Data-driven decisions

Education

Bachelor's degree in Engineering/Science/Quality Management

Job description

HCLTech Switzerland is seeking an experienced Supplier Quality Engineer to join the Quality team in a highly regulated environment. You will ensure compliance, drive quality excellence, and support NPI, transfers, supplier development and process improvements across service centers.

You will lead quality initiatives, collaborate with regulatory and customer teams, track KPIs, close NCs/CAPAs, and mentor regional quality coordinators as needed. A strong background in ISO 13485 and GMP is required.