Job description

JOB DESCRIPTION:

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

Supervisor - Sr. Quality Engineer

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.
• Provides support and communication with Operations, R&D/Engineering, and customers to resolve quality issues and other related product concerns.
• Conducts projects and provides support and communication with Operations and R&D/Engineering to achieve successful closure.
• 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
• Quality System Procedures. Assists in the development and administration of quality assurance procedures and activities to ensure products and processes are in compliance with quality standards and regulations. Develops the quality system by implementing best practices.
• Supports product acceptance activities. Reviews production records to ensure compliance of documentation and related processes, and makes final decision on the release of accepted product.
• Oversees the evaluation and disposition of non-conforming product and processes identified during production or other quality-relevant processes. Participates in root-cause investigations related to (internal) customer complaints. Analyzes and escalates issues in a timely fashion.
• Reviews the analysis of returned products from Customer Complaints in order to determine root causes and if need be corrective action. Initiates disposition of returned complaint material including rework, repair or scrap decisions. Supports submissions to regulatory agencies (MDR/Vigilance system).
• 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.
• Participates in design review and document release related to products, tools, and processes. Ensures rationales and applies statistical techniques in order to guarantee compliance with regulations.
• Participates in the assessment of new suppliers focusing on review
• 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.

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