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.
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.
• 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