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The company

Our client is a professional Medical Devices organisation, based in Noord-Brabant Netherlands. Quality supervisors manages and implements the company’s quality assurance and control systems to ensure proper execution of products and customer satisfaction and so contributes to the growth and profitability of the company.

Role description

• Implementation of the Quality Management System– CAPA/Deviations/Internal Audits/Complaints – in line with procedures and regulatory requirements
• Lead and develop the Quality Team within the site, communicate expectations clearly and ensure staff is appropriately trained
• Quality metric reporting and trending, with escalation of quality issues to senior management team
• Complete quality investigation and product risk assessment for product disposition
• Provide leadership in change management and risk assessment
• Conduct, lead, or direct product complaint investigations
• Facilitate and support external audits
• Conduct and implementation of the internal Audit programme
• As part of the management team, support and execute cost of quality and project improvement initiates
• Ensure team is trained to FDA QSR, ISO 13485 / 14971 and MDSAP requirements

Responsibilities

• Personnel Staffing and Management
• Problem Solving and Analyzing
• Attention to detail
• Auditing
• Change management
• Goal Setting
• Communicating/Leading
• Processes Improvement
• Project Managing (includes AFE process)
• Fiscal Managing (includes budget preparation)

Requirements

• 5-7 years quality experience, including previous supervisory experience.
• B.S. or B.A. in Physical Science, Engineering, or other related discipline
• Knowledge of applicable foreign and domestic regulations
• Knowledge of quality auditing techniques
• Knowledge of process validation techniques
• Knowledge of resource planning
• Knowledge of project management skills
• Strong technical writing skills and attention to detail
• Ability to speak, read and write in English & Dutch

Other information

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Ewout de Jong.


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SIRE Life Sciences®

Veröffentlicht von: SIRE Life Sciences®
Veröffentlicht am: 06-01-2020
Land: The Netherlands
Region: Noord-Brabant
Beschäftigung: Festanstellung
Sachverstand: 6 - 10 Jahre
Standorttyp: Auf locatie
Bildung: Master
Sprache: Englisch
Sektor: Medizinische Geräte
Spezialisierung: Qualität

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Kontakt

SIRE Life Sciences B.V.

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 20 658 9800

SIRE Life Sciences Deutschland GmbH

Fünf Höfe
Theatinerstraße 11
80333 München
+49 (0) 89 3803 8966

SIRE Life Sciences UK

702 Howard House Dolphin Square
SW1V3PQ London
+44 7307 179882

SIRE Staffing Solutions B.V.

Keizersgracht 440A
1016 GD Amsterdam
+31 (0) 20 658 9804