Supplier Quality Engineer

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

Supplier Quality Engineer

Location:Switzerland

About the Role

We are seeking an experienced Supplier Quality Engineer to join our Quality team.

The successful candidate will be responsible for ensuring compliance, quality excellence, and continuous improvement across service centers and supplier operations. This role serves as the primary point of contact for quality and regulatory compliance initiatives, supporting new product introductions (NPI), transfer projects, supplier development, and process improvement activities within a highly regulated environment.

Key Responsibilities

• Act as the primary quality representative for Service Centers regarding cost improvement initiatives, NPI activities, and transfer projects.
• Ensure compliance with Quality System procedures and support consistent execution across service sites.
• Collaborate with Customer Quality teams to address service evaluations, customer complaints, and reporting requirements.
• Monitor and track quality performance metrics and KPIs across service centers.
• Support timely closure of Non-Conformances (NCs), Corrective and Preventive Actions (CAPAs), and audit observations through cross-functional collaboration.
• Conduct investigations, document quality deviations, and coordinate corrective actions.
• Deliver training on quality system procedures and process changes.
• Maintain compliance with applicable FDA regulations, ISO 13485 requirements, and GMP standards.
• Support deployment and monitoring of quality targets during project implementation and post-delivery phases.
• Perform data-driven analysis to identify trends, risks, and improvement opportunities.
• Evaluate process changes through risk assessments and ensure compliance with Quality System Regulations (QSRs).
• Lead supplier quality improvement initiatives and support continuous process optimization.
• Potentially manage and mentor a small team of regional quality coordinators.

Required Qualifications

• Bachelor's Degree in Engineering, Science, Quality Management, or a related discipline.
• Minimum 5 years of experience in a senior Quality Engineering or Quality Assurance role within: Medical Device Industry Pharmaceutical Industry Life Sciences Other highly regulated manufacturing environments Lead Assessor qualification in ISO 13485, QSR, or equivalent quality standards.
• Strong expertise in: ISO 13485 GMP (Good Manufacturing Practices) Quality System Regulations (QSR) SPC (Statistical Process Control) Advanced Quality Planning Product Validation Root Cause Analysis CAPA Management NC Management Experience supporting product transfers, manufacturing scale-up, or start-up activities.
• Knowledge of production and manufacturing processes.
• Proven ability to lead supplier quality and continuous improvement projects.

Key Skills

• Excellent verbal and written communication skills.
• Strong stakeholder management and influencing capabilities.
• Project management expertise.
• Analytical and data-driven decision-making skills.
• Strong organization and attention to detail.
• Problem-solving and root cause investigation expertise.
• Ability to work effectively in cross-functional and global teams.
• High level of proficiency with quality management systems and digital tools.

Preferred Qualifications

• Lean Six Sigma Green Belt or Black Belt Certification.
• Previous people management experience.
• Project Management Certification.
• Knowledge of Orthopaedic products and medical device manufacturing processes.
• Experience working with global suppliers and service organizations.

About us

HCLTech Switzerland helps enterprises transform and innovate in a digital‑first world.

Backed by global capabilities and deep local insight, we deliver future‑ready solutions.

We believe in collaboration, quality, and impactful technology.