Quality System Manager / Lead Auditor

REGEDENT AG is a Swiss company headquartered in Zurich/Switzerland. Thanks to many years of experience in the fields of regenerative and implant dentistry, REGEDENT offers high-quality, customer-tailored products and solutions, enabling profession-als to improve their patients’ health and quality of life. REGEDENT develops, manufactures and markets innovative, clinically proven regenerative solutions in periodontal and implant dentistry for optimized treatment and long-term patient care.

To strengthen the Quality & Regulatory Affairs team, we are looking for an experienced, result-oriented and committed professional (m/w/d) as Quality System Manager / Lead Auditor (80-100%).

Your key responsibilities

• Act as management representative of REGEDENT
• Create, review and maintain the quality management manual (QMH), including quality policy and quality objectives
• Maintain and continuously improve the Quality Management System (QMS), driving lean, effective processes and documentation
• Evaluate QMS-related changes and assess impact on compliance and effectiveness
• Plan and execute internal and external audits and ensure timely execution of follow-up actions
• Lead the resolution of QMS-related nonconformities and quality events, including corrective and preventive actions taken and the assessments of their effectiveness
• Support processing of 3rd party product complaints and non-conformities in close cooperation with legal manufacturers
• Build a strong quality culture within the company: deliver QMS training and increase QMS awareness, execute management reviews and support data-driven improvement
• Execute evaluation and coordination of QMS-relevant questions from customers, suppliers and conformity assessment/ notified bodies as well as internal functions

Your profile

• University degree in life sciences, engineering, or a related field (or equivalent qualification)
• 3+ years of applied quality management experience in life sciences or another regulated industry (ideally dental/medical devices) with strong ISO 13485 know-how Education in regulations such as European Medical Device Regulations, Swiss Medical Device Ordinance, US 21 CFR and the ability to translate requirements into practical QMS solutions, completion of ISO 13485 and ISO 19011 training course, incl. certification
• 3+ years of professional experience in audit planning and execution
• Excellent communication and strong stakeholder management skills, ability to build strong relationships and act as team player
• Strong result orientation and business sense
• Well-organized and structured, self-starting, and comfortable working independently in a fast-paced, international environment.
• Languages: English fluent; German fluent; additional languages welcome

What we have to offer

You can expect a challenging and rewarding role with real impact, where you can actively shape structures and processes. You will work in a professional, collaborative environment that values initiative, responsibility, and continuous development.

Interested?

For further information, Sarah Calvi and Barbara Tomljenovic will be happy to assist you at
+41 44 545 80 80. Please submit your complete application documents via application button.