You are looking for a professional challenge that allows you to work in a fast-moving start-up in order to endorse responsibilities in Quality?
You want to use your expertise in Quality to contribute to operational activities in that field but also to strategic projects? Thanks to your experience in Medical Devices you are able to work autonomously and to participate to the development of the scaling-up phase?
Plus One can offer you this great challenge:
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.
The Senior Quality Assurance Engineer will support or lead the development and implementation of quality improvement projects and assist in resolving deficiencies impacting compliance with regulatory standards.
Your key responsibilities:
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
If you are interested in this challenging opportunity, please address your application (CV and short motivation text, both in English) to our recruitment partner, Plus One:
Only selected candidates will be contacted.