Senior QA Engineer - Medical Devices - Netherlands

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Senior QA Engineer – Medical Devices – Netherlands

Type: Permanent

Salary: Negotiable

Purpose:

The Sr. Quality Engineer collaborates with Quality management to recommend, design and implement functional process improvements. Develops, establishes and maintains quality methodologies, systems and practices which meet internal, customer and regulatory requirements. Provide compliance guidance and support for technical development concepts, regulatory, operational, or systems/services. May mentor cross-functional stakeholders on implementing Quality processes and procedures as appropriate.

Responsibilities include:

• Apply effective, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.

• Assure the development and execution of streamlined business systems, which effectively identify and resolve quality issues.

• Communicates non-conformances to owners, managers, directors, and upper management.

• Supports departmental, functional, divisional, and corporate quality goals and priorities.

• Plans, schedules, and conducts supplier audits/ assessments of their quality systems and procedures.

• Act as leader or team member in supporting quality disciplines, decisions, and practices.

• Builds quality into all aspects of work by maintaining compliance to all quality requirements.

• Participates on CAPA and Lean Business project teams as appropriate.

• Other duties as necessary or required by the department or organization.

Experience and skills

•Good knowledge of the English language

•Flexible and representative attitude

•Computer literate, network knowledge required

•Good social and communication skills

•Creative thinking and innovation

•Experience with major systems (e.g. eCAPA, PDM, VIP) desirable

•Strong analytical skills

•Solid project management skills

•Experience with Lean Business Process (LBP) methodology

Amsterdam, rotterdam, Eindhoven, Antwerp, Maastricht, leuven, breda, Alkmaar, Netherlands, Europe, drachten, Arnhem, Leeuwarden, Groningen, assen, leiden, holland, arnhem, nederland, Nijmegen . QA / QUALITY ASSURANCE / QC / QUALITY CONTROL / ENGINEER / ENGINEERING / CAPA / AUDITOR / AUDITS / AUDITING / SCIENTIST / ASSOCIATE / REPRESENTATIVE / QMS / QUALITY MANAGEMENT SYSTEMS / 13485 / MEDICAL DEVICES / HEALTHCARE / PHARMA / MEDICAL / HOSPITAL / MED TECH / MEDICAL TECHNOLOGY