Job Title: Medical Devices Specialist
Are you an expert within medical devices and passionate about helping companies in this area in their growth or to achieve their ISO13485 certificate?
Responsibilities:
* Conduct internal audits regarding ISO13485, Quality management systems, Quality Assurance, etc.
* Implement and maintain Quality Management Systems according to ISO13485.
* Identify and implement optimizations within quality and quality systems.
* Collaborate with production, QA, engineering, QC, process/validation engineers, supply chain, etc.
* Develop Standard Operating Procedures (SOP), related Work Instructions (WI), forms, checklists, protocols, and reports.
* Track and report on project deliverables as a project consultant.
* Coach small teams and work independently.
* Prepare documentation for filing to authorities.
* Follow regulations on medical devices and share knowledge within the team and at customers.
* Support in setting up timelines for the go-to-market strategy in light of applicable regulations and customer business plans.
Requirements:
* Scientific master's degree: engineer (bio, industrial, civil), industrial pharmacist, etc.
* Experience in the life science industry and in GMP, preferably in medical device projects.
* Knowledge of quality system standards (ISO 13485), regulatory standards for Medical Devices (21CFR820 & EU MDD/MDR) or software used for Medical Devices (IEC 62304).
* First experience with audits is an advantage.
* Good project management skills.
* A resilient, hungry for knowledge, no BS mentality, innovative, and not too serious individual.
What We Offer:
* An attractive and complete salary package.
* Sustainable careers and meaningful connections.
* A knowledge-based company.
* Work for an award-winning company.
Our Promise:
* Offer the best possible environment to thrive within the life sciences.
* Create a joyful community where individuals can be themselves.
* Grow together as unique individuals.
Interested? Send us your CV and motivation letter.