Description de l'annonce:

Purpose of function

 • Ensure effective document control Management: control of the documents of the Quality Management system as required per ISO13485.

 • Participate in the continuous improvement of the Quality Management System.

 • Monitor the measuring tools and equipment calibration.

 • Support Supplier Quality Management. 

• Internal auditor: conduct and support internal audits. 

Main responsibilities and accountabilities

 • Control of the documents of the Quality Management system as required per ISO 13485.

 • Define and implement quality control documentation

• Manage the electronic document management system

 • Ensure relations with document tools suppliers.

 • Participate to the improvement of the Document Control system process taking into consideration the needs of the organization (i.e. including investigation and implementation of specific software if needed)

 • In charge of the archives management of the documents related to Quality System. 

• Ensure the good implementation of QMS documents (Paper and Electronic) according to ISO13485 standards

 • Create work instructions (WI), check lists (CL) and inspection forms (IF) with the Quality engineer.

 • Participate in the supplier’s management process (evaluation, certification). 

• Ensure effective and efficient application of Quality Engineering tools and techniques (Statistical analysis, sampling plan determination). 

• Conduct and support internal and/or supplier’s audits

 • Measuring equipment management: Calibration/verification planning.

 Authority 

Signature for QMS documentation.

 Requested Qualifications (Education and Experience) 

• University graduation 

• A few years’ experience in quality assurance, preferably in Medtech industry

 • Knowledge of equipment maintenance and calibration is a plus.

 • Knowledge in electronic documents management is a plus. 

• Basic knowledge in metrology. People management skills: ability to effectively direct the work of a group, to provide direction and foster the long-term learning and professional growth of others. 

• Good command of English in writing and reading •

 Excellent command of Microsoft Office package. 

Personal Attributes 

• Accountable, rigorous, results oriented.

 • Excellent communication skills