Regular
Full time
At the heart of CSA Group is a vision: making the world a better, safer, more sustainable place. It's been part of our mission for nearly one hundred years: from the first engineering standard for railway bridges developed in 1919, to more than 3,500 standards, codes & related products today.
Headquartered in Canada, with a global footprint of more than 30 labs and offices across Europe, Asia and North America, CSA Group tests, inspects and certifies a wide range of products - from every day househould items to leading edge technology-to meet exacting requirements for safety, performance and environmental impact.
Our employees take pride in making a difference in people's lives through the work that we do. We're looking for people like you to help make it happen.
Primary Function:
Conducting on-site audits of quality management systems of manufacturers of medical devices and in vitro diagnostic medical devices, as part of the audit team. Person can take co-auditor or lead auditor role.
Conducting technical file assessments of medical devices and IVDs according to the general safety and performance requirements (GSPR) of MDR/IVDR Annex I for medical devices up to class III, incl. active and non-active implantable devices with intensified scrutiny towards European Competent Authorities (e.g. EMA) and IVD class D, consisting of physical, electrical, biological, chemical and clinical aspects for the safe use and application of medical devices and IVDs.
Conducting the assessment and evaluation of clinical data/studies of manufacturers.
Principal Duties & Responsibilities:
Understanding the Business
The Assessor
- conducts management system audits on-site, remotely or in the form of a document review as specified and scheduled for each individual project, depending on the individual technical authorization.
- conducts the assessment of medical device product files up to class III, including such incorporating a medicinal device or derivates of human or animal tissue or cells or other special properties which include an extended scrutiny and the involvement of the European Medicinal Agency and in vitro diagnostic medical device product files up to class D, depending on the individual technical authorization.
- conducts the assessment of customers’ clinical data, clinical studies and the related evaluation reports, depending on the individual technical authorization.
- conducts the assessment unaffected from any personal interests or external influences.
- provides input to the assessment reports and – where applicable – non-conformance reports on the commissioned projects.
- ensures that commissioned portions of assessments are conducted according to the CSA code of conduct and code of ethics and applicable principles of good auditing practice, following the requirements of the underlying certification programs. In this responsibility the role is expected to contribute to a statement on conformity and a recommendation for certification of the client.
- provides feedback support with implementation, maintenance and improvement of assessment processes, procedures and protocols in line with both internal and external Authority expectations.
- represents CSA whenever in touch with one of CSA’s clients
Working Well with Others
- Cooperating with audit team, product reviewers and clinical experts
- Cooperating with certification decision maker and project planner
- Team player
Delivering Results
- Ensure accurate on-site assessments and deliver audit results in a timely manner
- Autonomous working mode
- Analytical thinking, quick learner, thinking “outside the box”
- Assertiveness and ability to resolve conflict situations
Concern for Safety
- Understand and pro-actively implement CSA Group safety policies and guidelines
Preferred Education & Experience:
- University degree in medical or scientific university or polytechnic studies or comparable professional knowledge in relevant areas, e.g. medicine, chemistry, physics, pharmacy, medical device engineering, certified engineer with relevant work experience
- For on-site auditor: min. six years of professional experience in the field of health care products, medical devices and/or IVD (e.g. design, manufacture, inspection, testing)
- For product reviewer: min. six years of professional experience in the field of health care products, medical devices and/or IVD (e.g. design, manufacture, inspection, testing)
- For clinical expert: min. five years of relevant clinical experience
- Min. four years of professional experience in relation to quality management systems, preferably ISO 13485-based
- Conduct of assessment:
- For product reviewer: min. five (5) product file (min. MD class IIb, IVD class C) reviews per year over the last three (3) years
- For on-site auditor: min. thirty (30) on-site audit days in min. three (3) third-party audits as lead auditor per year over the last three (3) years, preferably with high risk MD/IVD manufacturers
- Preferably profound knowledge of the relevant regulations, directives and guidelines for certification of MD/IVD devices (Regulations (EU) 2017/745 and 2017/746), relevant MDCGs as well as the role of the Notified Body
- Preferably successful participation in recognized lead auditor course for ISO/IEC 17021-based audits, preferably related to ISO 13485
- Preferably profound knowledge and understanding of risk management and harmonized technical standards.
- Preferably profound knowledge of quality management principles and related standards
- Preferably profound knowledge in other regulatory medical certification programs (e.g. MDSAP, TCP, HKMDACS, UKCA, JPAL, FDA)
- Preferably language skills in professional and technical English
- Integrity and ethical behaviour
