Our team of consultants understand the process within medical device manufacturers, whether the product is hardware, software or diagnostics.
From building quality processes in production locations, establishing new CAPA and auditing systems to Vigilance activities, we spend our working days understanding the role of Quality professionals from start-ups with 10 people to the global players with 15,000+ employees.
Quality Management/Quality Assurance
No two roles in quality management are the same, and we know that each company has it's own challenges, projects and development plans that the QM function will bring to life.
Our network is built strongly on the foundation of knowing ISO 13485 and the documentation required for compliance, and from there understanding your focus in the device lifecycle.
Whether you are working broadly across the QM/RA topics or responsible for medical safety and CAPA - we have seen it all and want to hear about your challenges and aspirations.
CAPA and Validation
From building new CAPA systems to be compliant with the MDR or establishing a risk management reporting structure compliant to ISO 14971, we know the challenges and project focusses going through the medical device industry at any one time
Looking at manufacturing process validation and CSV, our network has technical expertise to comply with the quality standards requirements.
PMS and Vigilance
Medical device safety is always at the top of everyone's mind in this industry. Our consultants are constantly updating their knowledge with regards to post-market surveillance requirements, PMS and PSUR reporting.
We have supported candidates to be successful in roles where safety forms part of a broader role, or for larger medical companies who need a dedicated safety professional responsible for a proactive and comprehensive vigilance system.
Auditing and Supplier Quality Assurance
Whether you are looking after the devices during production in QA, responsible for MDSAP implementation or visiting suppliers to ensure they are adhering your company quality assurance agreements, our consultants have covered roles all fields.
We understand the importance of strong negotiation, communication and stakeholder management skills to drive the relationship forward a smooth, compliant route to market.
Watch our video to learn about our recruitment expertise in Quality
Quality management in the medical device industry is critical to ensure the safety, efficacy, and compliance of products. Here are some best practices in quality management for this sector: ISO 13485: This international standard specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical devices and […]
Quality management in the medical device industry is particularly critical due to the potential impact on patient safety and regulatory requirements. In order to assist you, we put together this list, with some common pitfalls to watch out for: Inadequate Design Controls: Insufficient Risk Management: Poor Supplier Quality Management: Inadequate Corrective and Preventive Actions (CAPA): […]
Preparing for a career move in sales? Here are five key steps to succeeding at interview. Sales professionals have a delicate balancing-act to perform at interview time. Often employers are hoping to see a range of skills and personality traits, several of which overlap and a few of which seem to flatly contradict. You need to be […]
I spend 90% of my day getting to know professional candidates across Germany in the field of Medical Devices, especially in roles focussed on Regulatory Affairs and Quality. My primary goal is to get to know you better, and dive-deeper into, well, everything! I am inquisitive about your studies, curious about your thesis topic, why […]
