Objective of the role:
MEDCERT is an accredited Certification Body for ISO 13485, recognised auditing organization under MDSAP and approved Notified Body for Medical Devices Regulation. We provide global market access by certifying the safety and quality of products and systems to international safety and quality standards and regulations. Our high professional standards and our sustainable approach guarantee you a forward-thinking work environment, within an organisation that invests in its employees, and is committed to providing you with continued development.
Medical Devices – Product Assurance
The production of medical devices is a strictly regulated business. MEDCERT is a Notified Body, providing services that secure our customers’ market access around the world. We assist the industry in ensuring medical devices are safe, effective and of the highest standard and quality.
We are expanding our team and now seeking Sterilization Experts on either a full-time or freelance basis. The successful candidates will be responsible for planning and conducting audits based on the requirements of ISO 19011 and ISO 17021 and the accreditation rules for Certification Bodies of quality management systems within the scope of ISO 13485 and sterile medical products (issued by DAkkS)
• Successfully completed course of study of medicine, natural sciences or engineering science at a university or technical college (“Fachhochschule”). Only in special cases which have to be justified and comprehensible equivalent knowledges and skills.
• Sufficient knowledge and experience in the areas directly related to the production of sterile products
• 4 years of professional experience including at least 2 years of employment in the areas directly related to the production technology and/or sterilization technology to be assessed or equivalent experience with general process technology
• Appropriate provable Knowledge of the European and national medical device regulation.
• Experience and/or training in clean-room technology, determination of bioburden, validation of cleaning, disinfection, and sterilization procedures, sterile packaging
• Proof of successful participation in at least one course of study on validation of sterilization with ethylene oxide and/or radiation and/or steam in accordance with EN 11135, EN 11137 EN 17665 and the requirements for medical products to be labelled as sterile, or equivalent qualification
• Basic knowledge in the area of hygiene
• Knowledge of staff hygiene, environmental monitoring, determination of EO- or other residuals
• Fluent in English, both spoken and written
• Structured, able to take initiative and work independently as well as part of a team
• Good communication skills and customer focus
• Ability to cope with a dynamic and changing environment
• Strong software skills (Microsoft Office)
• Cross cultural collaboration
DNV is an independent assurance and risk management provider, operating in more than 100 countries. Through assessment and digital assurance solutions, DNV helps companies build trust and transparency around products, assets, supply chains and ecosystems.
Whether certifying products, verifying claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results.
Combining sustainability, supply chain and digital expertise, DNV works to create new assurance models enabling interaction and transaction transparency across value chains. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers.
Driven by its purpose, to safeguard life, property, and the environment, DNV helps tackle the challenges and global transformations facing its customers and the world today and is a trusted voice for many of the world’s most successful and forward-thinking companies.
DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity!