Quality Assurance Manager

In billions of syringes and in every second car worldwide Datwyler components make an important contribution to the safety of patients and drivers. The high-tech company focuses on high-quality system-critical elastomer components and holds leading positions in attractive global markets such as healthcare mobility connectivity general industry and food & beverage. With over 25 production sites on four continents sales in more than 100 countries and over 8000 employees the company headquartered in Switzerland generates annual sales of more than CHF 1000 million.

Our employees are the heart of Datwyler - we treat each other with respect trust and appreciation. We have strong roots and values that have been well established in our 100-year corporate history. Become part of our great team as a...

The Quality Assurance Manager supports and strengthens the sites Quality function by ensuring that all operations comply with GMP regulatory requirements internal quality standards and customer expectations. Working closely with the Director of Quality this role oversees daytoday Quality Assurance (QA) activities depending on the organizations structure. The Quality Assurance Manager drives continuous improvement maintains a strong quality culture and ensures the consistent manufacture of safe effective pharmaceutical products.

Essential Functions

Quality System Oversight

• Leads the Regulatory and External Customer Audits including preparation execution and follow-up.
• Maintains and continuously improves the sites Quality Management System (QMS) in alignment with ISO 9001 ISO 15378 and other applicable regulations.
• Oversees deviation management CAPA change control complaints and risk assessments escalating critical issues to the Director of Quality.
• Ensures timely and compliant batch record review and product release processes.

Compliance & Documentation

• Ensures all GMP documentation is accurate complete and maintained according to data integrity principles (ALCOA).
• Reviews and approve SOPs validation protocols/reports and quality-related technical documents.
• Provides regular compliance updates and quality metrics to the Director of Quality.
• Monitors compliance trends and implement corrective actions where needed.

Leadership & Team Management

• Manages and develops QA staff providing coaching training and performance evaluations.
• Collaborates with the Director of Quality to set departmental goals allocate resources and align quality initiatives with site strategy.
• Fosters a culture of quality accountability and continuous improvement across the organization.
• Collaborates crossfunctionally with Production Engineering Supply Chain and R&D.

Continuous Improvement

• Leads quality improvement initiatives using tools such as Lean Six Sigma and root cause analysis.
• Identifies opportunities to streamline processes while maintaining compliance.
• Tracks and reports quality KPIs to senior leadership.

Experience and Education Requirements

• Bachelors Degree required. Science or engineering-related field a plus
• 5-7 years of relevant work experience in a Q Manager/Engineer role
• Thorough knowledge of cGMP regulations and current industry practice
• Knowledge of ISO 9001 and ISO 15378
• Good knowledge of domain-specific legislation standards rules and procedures
• Fluent in English both verbal and written
• International travel propensity required
• Experience in customer-facing role desirable

Be yourself at Datwyler

We are convinced that people make the difference. At Datwyler you will experience diversity and a wide range of career opportunities that only an international company can provide. Together we are increasing our agility accelerating digitalization and fostering sustainability. For motivated and talented employees we offer interesting development opportunities with training and assignments in a global environment. With us you can contribute with all of your creativity and all your ideas.