Loading...

https://performancemanager5.successfactors.eu/Sulzer/HR-ad-sujet6_HC Dental.jpg

 

 

With a view to the future, we are expanding our Quality Department and are looking for a/an

 

Quality and Regulatory Manager Healthcare (M/F/D)

 

The Quality and Regulatory Manager is responsible for ensuring that the quality system requirements have been effectively established and effectively maintaned in accordance with applicable standards (ISO 13845) and regulations and for reporting on the performance of the quality system to management with executive responsibility.

 

He is in charge of the technical and strategic management of the site Quality and Regulatory, of the proper cooperation with other sites, and he is the main point of contact with certification bodies, competent authorities and customers for all Quality and Regulatory matters. He is the site Management representative according to ISO 13485.

 

The Quality and Regulatory Manager is ultimately responsible for the maintenance of the site certification status (ISO 13485) and for the regulatory compliance of the devices.

 

The scope is about a small virtual entity relying on external manufacturers. Embedded operations is not included in this position.

 

Your tasks:

  • You lead a small team of 1 employee and you are together responsible for all the quality and regulatory matters related to the site within healthcare.
  • With an hands-on approach tackle the daily quality issues and sort them out, while implementing a long-term strategy
  • He's repsonsible for all the site quality processes, such as: Quality control/acceptance activities, CAPA, complaints, internal audits, Design Control, Management Review… 
  • Ensure that complaints are properly and timely managed, and that corrective actions are implemented as needed.
  • He's the front man during external audits (Certification Body, customers, …)
  • Compile and sustain the Technical Documentation (DHF, DMR, DHR, Technical Files,..)
  • Support customers for all the Quality and Regulatory topics related to the site products

 

Your qualifications:

  • Engineering degree
  • Deep knoweldge and working experience and expertise of ISO 13845 and RA topics (EU and US)
  • At least 5 years of experience as Qualty and Regulatory Manager (ISO 13485) in the medical device manufacturing environment (both as Supplier and as Legal Manufacturer). Highly beneficial previous experience with injection moulding 
  • Fluent in English (mandatory), German (beneficial)
  • Good knowledge of MDD and EU MDR (US FDA QSR would be beneficial)
  • Good knoweldge and experience of RA Technical Documentation, DHF, DMR
  • Previous experiences in leading and managing Certification Body audits, findings and follow-up, and customer audits
  • Previous experience in creating Technical Files/Technical Documentation (MDD/EU MDR) and DHF/DMR
  • Basic knowledge of Computer Software validation (validation of software for Quality purposes) and 21 CFR part 11

 

Location:

The workplace can be optional in Haag SG, or in Winterthur ZH.

 

Our offer:

An independent and versatile job in a dynamic, international growing environment. A varied field of work with high personal responsibility, a good working atmosphere as well as social and progressive employment conditions.

 

We are looking forward to receiving your application. Please be advised that we can only accept applications by our online-tool.

Please be advised that we are accepting only direct applications for this position.

 

Your contact at Sulzer Mixpac AG, Patrick Rainer, HR Manager, Rütistrasse 7, 9469 Haag, +41 81 414 72 70.

 

About us

Through its Mixpac, Transcodent, Geka and Cox brands, Sulzer develops and delivers innovative fluid applicators for the dental, adhesives, healthcare and beauty markets. Our IP-protected applicator solutions leverage our expertise in plastic-injection moulding, micro-brushes and two-component mixing to make our customers’ products precise, safe, unique and more sustainable.