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Quality System Manager / Lead Auditor
- Zürich, Zürich, Switzerland
- Zürich, Zürich, Switzerland
About
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%).
Quality System Manager / Lead Auditor
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, Calvi and Tomljenovic will be happy to assist you at
. Please submit your complete application documents via application button. jid58db8c9ws jit0521ws jiy26ws
Languages
- English
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