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QMS Manager

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The company

Our client is a professional Medical Devices organization, based in Netherlands. A leading health technology company focused on improving people's lives through education, engagement, and empowerment they make it possible to help those affected by the disease live a fulfilling life. Innovation, a systematic approach and a path to value is how they distinguish themselves. An organisation with an international character and a lot of opportunities to develop yourself and grow.

Role description

The Quality Manager is responsible for overall development, implementation, and maintenance of the organization’s Quality Management System (QMS). You work is based on the following three principles: simplify, clarify and control. You provide hands-on ownership to the site documentation system, master document lists and database/s, but also support to internal customers/site departments in the application, maintenance and improvement of
quality systems and department-specific processes.

Responsibilities

As a QMS manager you will be managing the QMS transition of the PQMS/PEPF and manage its deployment in the Markets, but also locally managing plans for all QMS parts in scope while maintaining compliance and effectiveness throughout the duration of the transition to the PQMS. You ensure the addition and management of any local QMS documents are in line with the evolution of the PEPF and the PQMS. Furthermore
- Following processes and operational policies in selecting methods and techniques for obtaining solutions
- Manage document management activities for involved processes
- You act as an advisor to subordinates to meet schedules and/or solve problems

Requirements

• Experience with working in a disciplined regulated industry and in applying automated technology.
• Seasoned knowledge of ISO 9001 and ISO 13485 (preferable including ISO 9001:2015 and ISO 13485:2016)
• Strong analytic skills
• Demonstrated ability to understand and develop processes.
• Excellent organizational and Project management skills with an attention to detail and follow-through
• Professional English written and verbal communication skills
• Ability to influence others to achieving goals
• Ability to work under a minimum of supervision
• Hands-on mentality

Other information

• Minimum of five years of similar work experience.
• Has a complete knowledge of company products and services


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SIRE Life Sciences®

Ref. number: 40495
Listed by: SIRE Life Sciences®
Listed on: 26-02-2018
Country: The Netherlands
Employment: Freelance
Expertise: 3 - 5 years
Location Type: On location
Education: Bachelor
Language: English
Sector: Medical Devices
Specialisation: Quality

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Contact

SIRE Life Sciences B.V.

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

SIRE Life Sciences Belgium BVBA

Science 14 Atrium
14b, Rue de la Science
1040 Bruxelles
+32 (0) 2 588 1277

SIRE Life Sciences Deutschland GmbH

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

SIRE Life Sciences Maastricht

ROOOMS Maastricht
Boschstraat 21
6211 AS Maastricht


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