PlusOne

Senior Quality Assurance Engineer - Medical Devices - Liège

Company

Our client is a medical device company specialized in improving clinical outcome of patients with impaired cardiac function, active in interventional cardiology. The company has developed a high potential proprietary technology that consists of hardware, software and catheter(s).

The technology is in advanced clinical stage with a short term ambition to move to a commercial phase, with various potential therapeutic applications.

Role

Job responsibilities include:

• Contribute to the Company Quality Objectives.

• Assist or lead various aspects of OEM project(s), working across the different departments, technical, and logistic functions to develop and execute each project plan:

o Collaborate with internal stakeholders from Research & Development, Sales, Clinical and/or Regulatory Affairs to understand internal position and direction as they relate to OEM project(s)

o Work with Supply Chain to define and operationalize the final deliverables such as creating and reviewing BOMs, creating part numbers, establishing label details etc.

o Assist sales team with the pricing strategy for OEM products

o Work with legal to implement Confidentiality Agreements (CDAs), Quality Agreements (QAA), Material Transfer Agreements (MTAs) and Material Supply Agreements (MSAs) as needed

• Assist or lead internal projects to establish new methodologies, capabilities or services.

• Performs supplier audits, internal audits and interacts with suppliers, customers and internal stakeholders to resolve non-conformances and drive continuous improvement.

• Participates in and manages quality assessments of internal operations and suppliers to analyze compliance and assess risk.

• Participates in product inspections and release.

• Analyse data to identify process improvement initiatives.

• Identify, document and report potential compliance issues affecting the company’s products, related processes, and the quality system.

• Manages the electronic document control system (eQMS)

• Other duties as assigned by direct Supervisor.

Product quality related authorities:

• Test Protocol & Report creatin and approval.

• Product testing and release.

Profile

• Master’s degree in Engineering or in scientific field

• Proven experience in Quality Management

• 3+ years in an ISO 13485 and MDD/MDR regulated environment

• Proven track record of driving up quality culture and compliance within a company

• Excellent communications skills, both written and verbal in English

• Excellent organisational skills with the ability to prioritise

• Ability to analyse complex activity including KPIs, metrics and other assessment tools

• Strong attention to details

Offer

  • A challenging and diversified position within a high-potential innovative medical device company.
  • To work in a human size, dynamic, respectful and professional environment.
  • International exposure, with learning and development opportunities.
  • An attractive compensation package in line with the position responsibilities and your experience.

Publication date

26.03.2021

Contact person

Gaëlle Minet

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