Technical Document Assessor to Intertek Medical Notified Body
Intertek Semko AB / Sjukhusteknikerjobb / Stockholm
2021-10-08
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Opportunity to widen your skills and grow your career?
Technical Documentation Assessor, home based position located in UK / Europe / USA
ABOUT THE ROLE:
The Medical Device Regulation (MDR) has now replaced the Medical Device Directive (MDD), Intertek was one of the first Notified Bodies to receive designation. As such and due to the expansion plans within the Intertek Medical Notified Body (IMNB), we have a great opportunity for Technical Documentation Assessors to join our Team. You will be responsible primarily for reviewing the client's Technical Documentation while driving continuous improvement, and always having a collaborative approach with the team and external partners and representing the company's values. This requires someone who has at least 3 + experience within this field and in particular experience of Active Medical Devices and Software.
Key Activities
• Validation of client Technical Documentation (TD)
• Pre-assessments of client TD
• Perform effective and Technically correct reviews of the client supplied Technical Documentation file
• Identifying and documenting issues to be addressed as necessary
• Lead and manage the technical assessment team (all assessors involved in the TD review) when required
• Liaise with the client to address any issues in a timely manner
• Correspond with clients as needed in respect of the scheduled assessment activity
• Performing Quality checks, Peer-reviews and/or other reviews
• Certification authority reviews under the guidance and oversight of the Certification Manager
Intertek's passionate and entrepreneurial culture inspires employees to be Ever Better, to own and shape their future, whilst giving the freedom, power and tools to develop a learning and development pathway that is unique to the individual. From their unique Skills for Success management and leadership development programme, which enables employees to gain skills and recognised qualifications to deliver outstanding Performance, to Learning Leadership that allows for a learning experience for new and future leaders to support innovation and engage their people through collaborative quality conversations, Intertek has amazing opportunities waiting just for you!
ABOUT YOU:
• Minimum of 3 years' experience of working in a Health Science related industry, Design, Manufacturing or Quality and Regulatory functions
• Ideally previous experience with Management System registrars, Notified Bodies or Testing laboratories
• Proven track record of working in a high-pressure environment with constantly changing priorities
• Able to effectively manage workload and be self-motivated
• Ideally experience of working in a regulated environment
• Proficiency in MS Office Suite and reporting with detail
• Accountability for delivering results; identifying the key challenges in complex situations
• Eye for detail and focused on delivering accurate reports.
• Ability to build effective relationships internally/externally
ABOUT INTERTEK:
• Global pioneers in the Quality Assurance industry, they are the only company in the world that delivers - on a truly global scale - a fully integrated portfolio of Assurance, Testing, Inspection and Certification services.
• Located in 1,000+ laboratories and offices across the world.
• Our innovation-led, end-to-end Total Quality Assurance ('TQA') proposition helps organisations operate safely, effectively and with complete peace of mind in an increasingly complex, fast-changing world across all industries.
• A focused strategy and culture that gives employees the right platform to grow and develop their careers
• Through our network of over 42,000 people in 1,000 laboratories and offices in 100 countries, Intertek provides quality and safety solutions to a wide range of industries around the world.
Should you have any questions you are welcome to contact Alexandra Strand Hägglund (HR)
alexandra.strand.hagglund@intertek.comVaraktighet, arbetstid
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Publiceringsdatum2021-10-08ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2021-10-30
Klicka på denna länk för att göra din ansökanFöretagIntertek Semko AB
Omfattning Detta är ett heltidsjobb.
Arbetsgivare Intertek Semko AB (org.nr 556024-0599)
Arbetsplats Intertek Medical Notified Body AB
Jobbnummer 6028179
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