Intertek is looking for Technical Documentation Assessors (TDA) who are experienced individuals focused on delivering accurate and robust assessments of our client’s technical documentation under the MDD (93/42/EEC) and the MDR (2017/745) for EC certification and under the UK MDR 2002 for UKCA marking.
The role is full-time remote/home-based position, with some travel required (approx. 15%).
The Technical Documentation Assessor (TDA) will lead and/or participate in the assessment of Technical Documentation within agreed timescales and will be responsible for submission of an accurate and sufficiently detailed Technical Documentation report. As a TDA, you will also be responsible for reviewing any client responses that may be received, and you will interact on a frequent basis with internal and external people including our customers, other members of the Notified Body team and management.
Perform pre-assessments and conformity assessment of client technical documentation (TD) to the requirements of the EU MDD and MDR and/or of the UK MDR 2002, according to processes and procedures, including:
Document the above assessments and reviews in accordance with the appropriate current local and global Intertek issued processes and complete them in timely manner.
Identify and document non-conformities as necessary.
As part of the conformity assessment and where approved to do so, review conformity of microbiology and sterilization, biocompatibility and/or clinical data evaluation
Liaise with the client to address any findings in a timely manner.
Lead and manage the technical assessment team (all assessors involved in the TD review) when required by the assessment project.
Perform quality checks, peer-review, and/or sign-off of other assessor’s assessments prior to submission of report to client
Raise suspension documentation as needed where findings are not adequately addressed.
Perform reviews of client's Change Notices, making recommendations for Certification Authority personnel on proposed actions.
Perform technical assessments of client's vigilance reports and determine next actions, including making certification recommendations.
As required, support audits of client management systems
Maintain accurate and current training and assessment history records as part of ongoing competency evidence and development
Assist, support, and attend all calibration sessions/assessor conferences, department meetings, and assessor team meetings.
4 year college/university degree in a science or technical field in relevant sciences, for example medicine, pharmacy, computer and software technology, engineering, biology, microbiology, chemistry, materials science, veterinary medicine, physiology, toxicology, human physiology; pharmacy; physics, or equivalent combination of relevant education and work experience.
A minimum of 4 years’ experience in the design, manufacture, testing and/or clinical use of medical devices.
Work in medical devices industry or closely related industries such as research and development, manufacturing, quality management, regulatory affairs;
Work in health services, universities, foundations, or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies
Work in the application of device technology and its use in health care services and with patients;
Testing devices for compliance with the relevant national or international standards;
Conducting performance testing, evaluation studies or clinical trials of devices.
Knowledge on EU devices legislation, harmonised standards and relevant guidance documents including knowledge on the general safety and performance requirements, risk management, clinical evaluation.
Proficiency in the English language, and strong communications and interpersonal skills.
Results oriented, sound judgment, organizational, and analytical skills.
Excellent computer and writing skills.
Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to see the detail and the bigger picture.
Ability to exercise effective time management skills in completion of assignments.
Ability to work independently and in teams
Must be willing and able to travel. Primarily domestic travel, some international travel may be needed.
Prior experience working at a Notified Body as a product specialist / Technical Documentation Assessor
Related 3rd party auditing industry management systems experience.
Working knowledge of non-EU relevant regulatory requirements for medical devices (US, Australia, Japan, Brazil, and/or Canada.)
Experience implementing/auditing to ISO 13485, ISO 14971, and medical device, regulatory requirements.
Specific experience/training on processes used in the relevant industry’s manufacturing (ex. sterilization).
Working experience in a wide range of medical devices.
This role requires:
The ability to express or exchange ideas by means of the spoken word. Must be able to convey detailed or important spoken instructions or information to others accurately, loudly, or quickly.
The ability to hear & perceive the nature of sounds at normal speaking levels with or without correction. Ability to receive detailed information through oral communication, and to make the discriminations in sound, perceiving sounds, including the ability to receive information thru oral communications.
The ability for visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading; visual inspection involving small defects, small parts, and/or operation of machines (including inspection); using measurement devices; and/or assembly or fabrication parts at distances close to the eyes.
The ability to walk, moving on foot to accomplish tasks and to move from one work location to another.
The ability to travel via airplane.
Telecommuting is allowed.
Additional Salary Information: We offer a salary and benefit package competitively placed within the local market, including medical, dental, vision, life, disability, 401(k) with company match, tuition reimbursement and more.
A career with Intertek means joining a global network of professionals dedicated to bringing quality and safety to life. Our vision is to become the world’s most trusted partner for Quality Assurance and we offer our employees the chance to make an impact with attractive growth opportunities in this industry on a global scale.
We are an Equal Opportunity Employer and do not discriminate against applicants due to veteran status or on the basis of disability. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, or gender identity.
Intertek is a drug-free workplace. As a condition of employment, all hires are required to pass a pre-employment drug test.
Internal Number: 2100015X
Intertek is a leading Total Quality Assurance provider to industries worldwide. Our network of more than 1,000 laboratories and offices with over 43,000 people in more than 100 countries, delivers innovative and bespoke Assurance, Testing, Inspection, and Certification solutions for our customers’ operations and supply chains. Intertek Total Quality Assurance expertise, delivered consistently with precision, pace, and passion, enables our customers to power ahead safely.
The Business Assurance group of Intertek provides a full range of business process audit and support services, including management systems certification, custom supplier audits, and training. Our range of services helps to ensure customer management systems are optimized to facilitate successful growth.