Quality Assurance Specialist

Responsibilities

• Manage and maintain the Quality Management System (QMS) to ensure compliance with ISO 9001 requirements.
• Support the site in guaranteeing continuity of quality systems and activities in alignment with global and local standards.
• Manage customer complaints, internal quality notifications, change control processes, and the CAPA process.
• Lead investigations related to complaints and nonconformances, partnering with operations, supply chain, and engineering.
• Support internal and external audits, including customer, regulatory, and ISO audits.
• Conduct annual training for site Internal Auditors and prepare for external certification audits.
• Define and implement quality-related projects to improve overall compliance and quality levels.

Requirements

• 3-5 years of relevant work experience in a Quality Assurance role.
• Thorough knowledge of cGMP regulations and current industry practices.
• Working knowledge of ISO 9001 and ISO 15378 standards.
• Fluency in English, both verbal and written.
• Bachelor's or Master's degree preferred.

Preferred Qualifications

• Experience working within classified or cleanroom areas.
• Experience in a customer-facing role.
• Knowledge of domain-specific legislation and relevant industry standards.

About the Company

Datwyler is a high-tech company specializing in high-quality, system-critical elastomer components for global markets including healthcare, mobility, and connectivity. With over 25 production sites on four continents and 8,000 employees, we provide essential components that contribute to the safety of patients and drivers worldwide.