Supplier Quality Engineer

HCL Technologies Limited; Zuchwil; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

HCLTech Switzerland is seeking an experienced Supplier Quality Engineer to join its Quality team. You will ensure regulatory compliance, drive quality excellence, and lead improvement projects across service centers and supplier operations.

You will serve as the primary contact for quality and regulatory initiatives, support NPI transfers, CAPAs, supplier development, and process optimization in a highly regulated medical device environment.

Qualifikationen

• Bachelor's degree in Engineering, Science, Quality Management, or related discipline.
• Lead Assessor qualification in ISO 13485, QSR, or equivalent quality standards.

Aufgaben

• Act as the primary quality representative for service centers on cost improvement, 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 NCs, CAPAs, and audit observations through cross-functional collaboration.
• Lead supplier quality improvement initiatives and support continuous process optimization.

Kenntnisse

Quality systems

CAPA management

GMP

ISO 13485

Risk assessment

Leadership

NPI support

Ausbildung

Bachelor's degree in Engineering/Science/Quality Management

Jobbeschreibung

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
• 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.
• 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.
• 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.