Auditor - Medical Device Directive
Intertek / Redovisningsekonomjobb / Stockholm
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Intertek är en ledande global leverantör av kompletta kvalitetssäkringslösningar. Vårt nätverk av mer än 1 000 laboratorier och kontor och över 40 000 medarbetare i fler än 100 länder levererar innovativa lösningar inom kvalitetssäkring, provning, inspektion och certifiering skräddarsydda för våra kunders verksamhet och leverantörskedjor.
Bringing quality and safety to life
Intertek are looking for thorough individuals, focussed on delivering accurate and robust audits within agreed timeframes and experienced within the medical device area, to take on the role as auditors within Intertek's Swedish Notified Body for MDD (93/42/EC). If you want to be part of our journey, we would love to hear from you!
About Us:
Intertek is the trusted advisor to many of the world's leading brands, companies and governments, and has earned a reputation for accuracy, reliability, integrity, and technical competence. Our 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 testing, inspection, and certification industry.
The Role:
The Notified Body within Intertek Semko AB is accredited to certify companies according to the EU Medical Device Directive (MDD). Reviewing documentation, assessing products, performing quality management system audits and unannounced audits are part of the certification and the Notified Body.
As an auditor in our Notified Body, you will perform audits of our customers within the medical device industry. Our customers are primarily based in Sweden, but we do also work with other parts of the world. You can therefore expect a significant amount of travelling.
In addition to the auditing, you will be required to coordinate audit activities with the audit team, assist customers with questions relevant to the audit and / or certification process, write audit reports, follow up on audit findings, participate in audit meetings and work on ad hoc projects, relevant to the job, that may arise.
We are currently expanding our area and therefore looking for a number of auditors. Today we are 12 employees at the Notified Body eager to optimise our processes, work more efficiently and expand our knowledge and competencies.
As an auditor you can expect to interact, on a frequent basis, with internal and external personnel including our customers, other members of the Notified Body team and management.
The role is permanent and based in Stockholm or Gothenburg.
Requirements:
At least 3 years' experience in the medical-technical industry e.g. within auditing, quality management, regulatory affairs, research & development or production/service.
Experience in one or more of the following is a distinct advantage:
• Notified Body / Medical Device Directive
• Technical File Review
• Auditing
• Medical-technical industry
• Electrical, sterile, dental or implantable devices
• Software
• Health care
• Risk management
• Scientific literature or clinical trials
• Medical device regulations
• Industry practice and standards
Education:
Higher education, MSc, and/or equivalent experience in either Health Science, Engineering or Quality/Regulatory disciplines related to the Medical Device or Pharma industry sectors.
Personal competencies:
As a person you are independent, organised, analytical, thorough and results-oriented. You have a keen eye for detail but can also take a step back to see the bigger picture when required. You are able to react effectively in stressful situations, have strong communication and interpersonal skills and the ability to define problems, collect data, establish facts and draw valid conclusions. Effective time management is also essential to the role.
Lastly, you have good working knowledge of Office systems, and speak and write Swedish and English fluently.
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.
If you want to be part of our journey, we would love to hear from you!
Should you have any questions you are welcome to contact Joacim Jonasson, 08-555 651 26.
Please send your application consisting of a CV and personalised cover letter to
joacim.jonasson@poolia.se by 31.Jan.2017.
Varaktighet, arbetstid
1 -
Publiceringsdatum2016-12-12ErsättningEnligt överenskommelse
Så ansöker duSista dag att ansöka är 2017-01-31
Klicka på denna länk för att göra din ansökanFöretagIntertek
AdressIntertek
Torshamnsgatan 43
16422 Kista
KontorsadressTorshamnsgatan 43
Jobbnummer 3207293
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