Sr Quality Engineer (Product Design & Development)

SHL Medical seeks a Senior Quality Engineer in Zug, CH, to oversee product design and development quality, ensuring compliance with medical device regulations and cGMP standards through risk-based approaches and design controls.

The company is looking for a Senior Quality Engineer to lead quality engineering efforts across product design and development. This role ensures that all new products and process changes meet regulatory standards and customer needs by applying risk-based methodologies and robust design controls. The engineer will collaborate with various departments to drive quality improvements and support digitalization initiatives within the quality management system.

Responsibilities

• Act as the primary Quality Engineering representative for all design control and product development activities.
• Maintain and improve the efficiency of Quality by Design principles throughout product development, process creation, and maintenance.
• Guarantee adherence to applicable medical device regulations and current Good Manufacturing Practices (cGMP).
• Lead and participate in initiatives to enhance product development and quality processes.
• Apply quality engineering tools and principles dynamically to support development projects.
• Integrate internal and external customer requirements into new products and future modifications using quality best practices.
• Contribute to digitalization programs focused on the Quality Management System (QMS) and Product Lifecycle Management (PLM).
• Support risk management efforts and guide product development decisions through a risk-based approach.
• Work with subject matter experts to identify and trace critical-to-quality attributes across all development phases and establish control strategies.
• Assist in reviewing simulations, designs, manufacturing processes, and engineering experiments (DOEs) to inform product and process development.
• Promote the adoption of Advanced Product Quality Planning (APQP) and Design for Six Sigma (DFSS) methodologies.
• Ensure all teams follow SHL Medical's procedures and standards during development and manufacturing stages.

Requirements

• At least 5 years of hands-on experience in product development from concept to launch within the medical device or pharmaceutical sector.
• Deep expertise in design controls and product development processes, especially for medical devices or combination products.
• Familiarity with ISO 13485, QSR 820, ISO 14971, IEC62366, and IEC62304 standards.
• Proven ability to establish processes, write procedures, and foster cross-functional collaboration.
• Strong communication and stakeholder management skills with a customer-focused mindset.
• Ability to build consensus and negotiate project deliverables, risks, and priorities.
• Self-motivated team player who thrives in international, cross-company environments.
• Solution-oriented with strong analytical and decision-making capabilities.
• Willingness to travel internationally up to 5% of the time.
• Fluent written and spoken English proficiency.

Nice to have

• Fluent written and spoken German proficiency.
• Bachelor's degree in engineering, life sciences, or a related scientific field.
• Training and practical experience with quality engineering methodologies such as APQP, DMAIC, Lean, or Design for Six Sigma.
• Working knowledge of statistical analysis and associated software.

What the company offers

• Engaging assignments within a rapidly growing and innovative industry.
• Opportunity to join a fast-growing international medical technology company.
• Modern working environment with multicultural and dynamic teams.
• Centrally located office in Zug, very close to the train station.