Quality Specialist to Intertek Medical Notified Body
The Role and Responsibilities
The Notified Body (NB) within Intertek is designated to certify products according to the EU Medical Device Directive (MDD 93/42/EEC). Reviewing product documentation, performing on-site quality management system audits and unannounced audits are part of the certification process.
In the exciting journey towards the Medical Device Regulation (MDR) and with recent organisational changes to strengthen the team, we are looking for a Quality Specialist to support our journey towards a robust and high performing Notified Body. Reporting to the Quality Team Leader and based in Stockholm, Sweden the role is full time and includes:
- Development and support for the implementation of procedures for the operation of the Notified Body.
- Lead and support Corrective and Preventative Action (CAPA)
- Perform investigations related to the handling of Complaints / Disputes
- Monitor the performance of processes through execution of internal audits
- Actively support quality leadership in monitoring and improving the quality system by driving continuous improvement
- Provide support for management review activities
- Escalate quality related issues to the Quality Team Leader
- Develop and provide training as subject matter expert on applicable quality related subjects
- Management of KPI reporting in QMS related activities
- Proactively drive Continuous Improvement initiatives for the Notified Body
- Support and maintenance of the Net Promoter Scores (NPS) to ensure customer focus and continuous improvements
- Communicate with clients professionally and in line with Intertek's values
- Comply with Intertek's Quality Management System
- Accountable for ensuring confidentiality and independence from commercial and other interests, and raising any existing or prior association with clients to line manager immediately
- Accountable for achieving KPI objectives specific to role
- Provide support in the organisation of external audits from Designating Authorities
- Liaison with the Designating Authority
- Provide Quality input to other departments
Intertek is a safe workplace with collective agreements, benefit package with pension, health care contributions and parental leave allowance. We have flexible working hours and encourage a good working climate and happy employees.
Competencies, personal attributes and skills
- The role holder should possess either an appropriate degree, college degree or other qualifications and/or experience in either Health Science, Engineering or Quality/Regulatory disciplines related to the Medical Device or Pharma industry sectors
- Has preferably at least 3 years' experience of either working in a Health Science related industry in Design, Manufacturing or Quality and Regulatory functions, or previous experience with either Management System registrars, Notified Bodies or Testing laboratories
- Has knowledge of the EU Medical Device Directives and Regulations and Quality Management Systems
- Has a keen eye for detail and is focused on delivering accurate and robust results within agreed timeframes.
- Operates ethically with the highest degree of professional integrity
- Fluent in English written and spoken, fluent in Swedish is nice to have
What you need to do now
In this process, Intertek Medical Notified Body is working with Hays. If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV today. We are looking forward to your application!
Your new company
Intertek is the trusted service provider to many of the world's leading brands, companies and governments, and has earned a reputation for accuracy, reliability, integrity, and technical competence. Our Assurance, Testing, Inspection and Certification services take us into nearly every field, from textiles, toys and electronics, to building, heating, pharmaceuticals, petroleum, food, cargo scanning and medical devices. In a world where a company's success depends on its reputation for quality, safety, and socially responsible products and processes, Intertek employees make a difference. Join the team at Intertek and work with some of the best, brightest, and most inspiring people in the assurance, testing, inspection, and certification industry.
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Audits, Management, Monitor, SCOM