Supplier Quality Engineer

Amaris seeks a Senior Supplier Quality Engineer in Zürich to oversee manufacturing transfers, ensure quality compliance, and drive continuous improvement initiatives.

This position focuses on guiding manufacturing transfer activities from initial project execution through final product release. The engineer is responsible for maintaining strict adherence to quality standards while leading continuous improvement efforts across the supply chain.

Responsibilities

• Conduct and authorize First Article Inspections (FAI) to confirm manufacturing readiness.
• Carry out and assist with Process Validation tasks, including Installation Qualification (IQ), Technology Media Validation (TMV), and Performance Qualification (PQ).
• Lead Advanced Product Quality Planning (APQP) efforts in collaboration with suppliers.
• Create, examine, and enter quality records into SAP and other Quality Management Systems (QMS).
• Work with Supplier Quality Engineers, Program Managers, and production teams to address and resolve quality concerns.
• Assist in supplier audits, inspections, and validation processes.
• Travel to manufacturing facilities in Thailand to aid in production validation and inspection activities.

Requirements

• Bachelor’s degree in Engineering, Manufacturing, Quality, or a closely related discipline.
• Seven to eight or more years of professional experience in Supplier Quality Engineering.
• Proven expertise in APQP, First Article Inspection (FAI), and Process Validation (IQ, TMV, PQ).
• Practical experience using SAP and Quality Management Systems (QMS).
• Background in supporting Manufacturing Transfer, New Product Introduction (NPI), or Production Transfer projects.
• Fluent English communication skills.
• Strong analytical, problem-solving, and stakeholder management capabilities.
• Willingness to travel to manufacturing sites in Thailand as needed.

Nice to have

• Prior experience within the Medical Device industry is highly valued.
• Familiarity with ISO 13485 and FDA 21 CFR Part 820 regulations is advantageous.

What the company offers

• Access to a comprehensive training system featuring an internal Academy with over 250 available modules.
• Opportunities to engage in meaningful initiatives through the WeCare Together program and sustainability commitments.
• A vibrant workplace culture that regularly hosts internal events, networking sessions, and team-building activities.

About the company

Amaris fosters an international community comprising over 110 different nationalities. The company promotes a dynamic environment where innovation, collaboration, and continuous learning are encouraged. Trust is central to their culture, with 70% of key leaders having started their careers at entry-level positions.

• An international community bringing together 110+ different nationalities.
• A dynamic environment where innovation, collaboration, and continuous learning are encouraged.