Quality Engineer II

ERServices seeks a Quality Engineer II in Bettlach, CH, to lead validation strategies and ensure regulatory compliance for medical device and pharmaceutical products.

This mid-level position operates within a global organization that delivers engineering, supply chain, and manufacturing solutions. The Quality Engineer II reports directly to the Quality Engineering Supervisor and plays a key role in maintaining quality standards across new product introductions and process improvements.

Responsibilities

• Direct validation strategies and quality projects for new product launches, technology rollouts, and manufacturing process changes.
• Manage the full lifecycle of validation activities, including Process Validation (IQ, OQ, PQ) and Computer System Validation (CSV).
• Create, perform, and assess Test Method Validations (TMV) to guarantee that testing procedures are precise and suitable for their intended use.
• Maintain strict adherence to GxP, GAMP, ISO 13485, and internal quality protocols, ensuring comprehensive documentation and readiness for audits.
• Offer technical guidance on manufacturing equipment and processes, supporting equipment lifecycle management, design transfer, and successful product launches.

Requirements

• Solid understanding of GxP, GAMP, ISO 13485, and validation best practices.
• Proven experience conducting Process Validation (IQ/OQ/PQ) and Computer System Validation (CSV).
• Technical grasp of manufacturing processes and associated equipment.
• Prior work experience in regulated sectors such as medical devices or pharmaceuticals.

Nice to have

• Familiarity with new product introduction (NPI), design transfer, and equipment lifecycle management.

What the company offers

• Progressive employment terms with a focus on long-term career stability.
• A dynamic and varied role within a global firm that maintains a strong local footprint.
• Significant autonomy and personal responsibility in daily tasks.
• An environment that encourages creative thinking and continuous learning.
• Performance bonuses, additional vacation days, and various other benefits.

About the company

ERServices is a global provider of engineering, supply chain, and manufacturing solutions. The company is committed to building sustainable processes that reduce environmental impact while fostering vibrant and diverse communities worldwide.

• Commitment to sustainability and minimizing environmental impact.
• Focus on building diverse and vibrant global communities.
• Emphasis on creative thinking and independent work.

How to apply

Documents to submit:

• Complete application documents