Quality Engineer Device Development

SHL Medical seeks a Quality Engineer for device development in Zürich. The role focuses on design controls, risk management, and regulatory compliance within a dynamic international team.

The company is looking for a professional to ensure the quality and effectiveness of product design and process development. This position involves establishing efficient design controls and risk management procedures while collaborating closely with various departments to meet regulatory standards.

Responsibilities

• Act as the Global Quality Engineering representative for all design control and product development matters.
• Facilitate the implementation of Quality by Design principles within ongoing projects.
• Drive Advanced Product Quality Planning initiatives and verify adherence to relevant standards.
• Lead or participate in efforts to improve product development and quality planning workflows.
• Apply Quality Engineering methodologies dynamically to both development and production projects.
• Integrate customer needs and requirements into new products and future modifications using best practices.
• Utilize appropriate Quality Engineering tools and techniques in line with company needs and regulations.
• Assist with risk management activities for medical devices and drug/device combination products.
• Help Subject Matter Experts identify and trace Critical to Quality (CTQ) characteristics.
• Support simulation studies, design reviews, manufacturing process evaluations, and engineering experiments (DOEs).
• Ensure strict compliance with SHL procedures and standards throughout all development and manufacturing phases.

Requirements

• Bachelor's degree or equivalent in a scientific or engineering discipline.
• Minimum of two years of experience in Quality Engineering or a related field.
• Familiarity with ISO 13485, QSR, ISO 14971, IEC62366, and IEC62304 standards.

What the company offers

• A competitive compensation package.
• Access to modern facilities and state-of-the-art technologies.
• Challenging projects within a fast-growing and innovative sector.
• Opportunity to work in a dynamic, international team of skilled professionals.
• Multiple avenues for personal and professional growth within a global organization.

About the company

SHL Medical operates in a rapidly expanding and innovative industry. The organization is characterized by a dynamic, international team composed of highly skilled professionals dedicated to excellence.

• Active participation in a fast-growing and innovative industry.
• Collaboration within a dynamic, international team of highly skilled professionals.