Daily new jobs

 

(Snr) Software QA Specialist

Share on social media:

Apply Save this job

1 person also applied on this job


The company

Our client is a professional Pharmaceutical and Medical Devices organisation, based in Brussels Hoofdstedelijk Gewest Belgium. Our client is an international market leader for the life sciences industry specialized in diagnostics and chemicals. They offer a broad range of products varying from pharmaceuticals to medical devices.

Role description

In your position as Senior Software Quality Specialist, your main focus is the maintenance, improvement and development of the Quality department for the site in Belgium. You will be operating with a Quality Management Systems according Software standards. You are a key contact person when it comes to issues and questions in relation the QMS for both internal and external stakeholders. You will be involved in creating training and the development of strategies and activities regarding quality. On a local level, you will interact with various departments among which Marketing, R&D, and the Manufacturing. Furthermore, you will be closely collaborating with international sites to ensure global alignment.

Responsibilities

As mentioned previously, you will overview and control all activities concentrated on the improvement of the Quality Department in alignment with other disciplines within the organisation. Furthermore, you are responsible for:
• Guidance and support to team members and various stakeholders across the organisation
• Ensuring that nonconformities are identified, performing GAP analyses, executing CAPA’s and implementing strategies of improvement
• Implementation, development and maintenance of ISO and FDA standards, in particular ISO 13485, IEC 62304, IEC 60601, IEC 62366,ISO 27001 and FDA QSR 820
• Taking responsibility during internal and external audits
• Offer assistance to RA practices such as the 510k submission, document control and CE IVD DOC
• Defining Key Performance Indicators for the EMA Quality Logistic site
• Checking test equipment for sufficient calibration and verification which should be suitable for specific verification and testing activities
• Development of training activities and execution
• Key contact person for all issues and questions related to the QMS

Requirements

• Bachelor or Master in Life Sciences
• Minimal 5 years of experience in Quality Assurance within the Life Sciences industry
• Excellent knowledge of ISO 13485, 21 CFR Part 820, ISO 14971 and ISO 27001, and preferably IEC 60601, IEC 62304 and ISO 62366
• Evidence of experience in relationship building and maintenance of relations with authorities and other external stakeholders
• Individual operator yet team player
• Excellent analytical and problem-solving skills
• Fluency in English and Dutch
• Strong communication skills and excellent negotiating skills
• Ability to travel around 5-10%

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.

Job alert

  • No registration required
  • Stay up-to-date on the latest jobs

SIRE Life Sciences®

Listed by: SIRE Life Sciences®
Listed on: 06-02-2019
Country: Belgium
Region: Brussels Hoofdstedelijk Gewest
Employment: Permanent
Expertise: 3 - 5 years
Location Type: On location
Education: Bachelor
Language: English
Sector: Medical Devices
Specialisation: Quality

Search again

Related jobs

Karim Oujalim
QA Manager

Belgium
Permanent
Quality

Thijs Claassen
Supply Chain Analyst

Belgium
Permanent
Quality

Karim Oujalim
QA Freelance

Belgium
Permanent
Quality

Naut van Osnabrugge
Project Manager API manufacturing

Belgium
Permanent
Quality

SIRE Life Sciences®
Validation Site Manager (QA) / Region Antwerp / Permanent / Life Science Sector / Salary € 4500 - € 5500 per month

Belgium
Permanent
Quality

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


SIRE Group GmbH

Platz 3
6039 Root
Luzern
+41 (0)43 508 1743

SIRE Staffing Solutions

Keizersgracht 420 C
1016 GC Amsterdam
+31 (0) 20 658 9804

SIRE Information Technology

Calypso Building
Kruisplein 480
3012 CC Rotterdam
+31 (0) 10 316 1066

SIRE Healthcare

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4640

SIRE Finance

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4630

SIRE Engineering

Calypso Building
Kruisplein 480
3012 CC Rotterdam
+31 (0) 10 316 6626

SIRE Human Resources

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4620

SIRE Staffing

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4650

Product Price