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.
The Role and Responsibilities
This role has accountability to ensure the Notified Body Medical Audits are performed as per the requirements set out in:
- EU Medical Device Directives and Regulations (e.g. 93/42/EEC)
- ISO17021 Accreditation
- Other programme specific requirements (e.g. ISO13485, CMDCAS, MDSAP, TCP)
Reporting to the Operations Manager with line management responsibilities the role also includes:
- Assist in developing the strategy and lead the significant potential growth in the Medical Product Assurance market, particularly in the USA and China with both a track 1 (short term) and track 2 (long term) focus.
- Apply to the new Medical Device Regulations (MDR) and ensure compliant and robust processes are in place before MDR Joint Assessment
- Develop the strategy, structure, people, and process with retention of key individuals critical to success
- MDR Joint Assessment passed successfully leading to successful accreditation.
- Lead the team through change:
- Robust performance people, talent management and engagement
- Develop the organizational culture and focus management more on customer processes
- QHSE (Quality, Health, Safety, Environment) - ensure that QHSE processes are established, implemented and maintained aligned with Intertek policies, law requirements and local regulations
- Management and accountable for the TD to ensure all are timely closed throughout the whole process
- Ensure the TD assessment activities are performed as planned by the coordinators
- Responsible to monitor outsourced processes related to audits
- Responsible for the selection, qualification and management of Auditors for the NB
- Accountable for achieving KPI objectives for the audit processes including turnaround time and customer satisfaction
- Responsible for employee and team development and coaching including e.g 1:1s, department meetings
- Provide technical expertise, support, guidance and coaching to all auditors
- Participate in COE meetings and drive continuous improvements in processes related to area of responsibilities
- Ensure adequate resources within Operations to comply with assessment activities
- Accountable for ensuring confidentiality and independence from commercial and other interests, and raising any existing or prior association with clients to line manager immediately
Competencies, personal attributes and skills
The expectations of our leaders are to drive continuous improvement and represent our value and give energy to others and support them in their role.
- 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
- 2 years’ experience as a lead auditor within Medical Devices or Notified Body
- Has preferably 1+ years’ experience in Management
- 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
- Good knowledge of the EU Medical Device Directives and Regulations and Quality Management Systems
- Has a keen eye for detail and is focused on delivering results within agreed timeframes
- Operates ethically with the highest degree of professional integrity
What we offer
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 satisfied employees.
The role is full time and based in Stockholm, Sweden.
Submit your application with resume and cover letter today, or as soon as possible. If you have any questions regarding the position, please contact Operations Manager Jonny Munter firstname.lastname@example.org