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Stellenbeschreibung

Thoratec Switzerland GmbH is an Affiliate of Abbott Medical and takes care of the development and manufacturing of our mechanical circulatory support devices, that are designed to support a broad range of advanced heart failure patients.

To complete our team in Zürich, we are looking for a

Team Lead – Regulatory Compliance and Quality Systems

Core Job Responsibilities:

• Analyzes aspects of and executes quality-assurance activities to ensure compliance with internal procedures and external standards and regulations.


• Supports the activities of the Quality organization with responsibility for results in terms of product quality, performance, and safety.


• Actively drives all defined Quality Systems goals and objectives at the plant level.


• Manages the document control system including maintaining the Document Control Order (DCO) System, maintaining DCO files including pending, closed and archived files.


• Maintains up-to-date knowledge of national and international (especially USA and European) quality-system regulations and standards.


• Evaluates and assures facility-wide compliance with all applicable quality systems standards and regulatory requirements by planning and executing tasks necessary to meet these requirements.


• Prepares facility for inspections and audits and interfaces with outside regulatory agencies during regulatory inspections.


• Analyzes and reports quality metrics and trends for key quality indicators to assist company management in decision-making process


• Assists in the development and administration of quality system procedures and activities to ensure products and processes are in compliance with quality standards and regulations. Drives improvement of the quality system by implementing best practices.


• Analyzes systematic trends related to non-conforming products or processes in order to determine root causes, and if need be, corrective and preventive actions. Takes ownership in resolving quality issues following the CAPA process.


• Leads his Team in functional and staff manner.

Experience/Training Required:

• Master degree in Science, Engineering or other Technical field is required.


• Three to five years of related experience in a medical device manufacturing environment.


• Knowledge of ISO, European and US regulations related to medical devices


• Experience in supervisory position.


• Comprehensive understanding of international and domestic medical device regulatory guidelines.


• Proficiency with personal computers, business and technical software.


• Strong math, problem solving, and decision-making skills.


• Highly developed verbal and written communication skills in German and English are a must have.


• Excellent organizational, time management, and multi-tasking skills.


• Ability to work in a team environment using effective interpersonal and negotiation skills.

Do you like the sound of this job and think you’ve got what it takes?

Then send us your CV today. We look forward to receiving your application online in pdf format.

     

Job-Familie

Operations Quality

     

Division

EPHF Electrophysiology & Heart Failure

        

Standort

Switzerland : Technoparkstrass 1 CH 8005

     

zusätzliche Standorte

     

Schichtplan

Standard

     

Reisen

No

     

Medizinische Kontrolle

Not Applicable

     

Wichtige Tätigkeitsbereiche

Not Applicable