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Medical Device Lead Auditor

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Certification
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046714 Requisition #

Job Title:  Medical Device Lead Auditor

Location: UK, Field based - National

Type: Permanent

Hours:  37.5 hours per week

Closing Date: 23/11/2019

Salary: Competitive

Company car provided

 

Benefits:  

 

10% performance bonus, retail discount scheme, private health cover, contributory stakeholder pension scheme and life cover. 


We have an excellent new opportunity for a Medical Device Lead Auditor to join our global organisation. The successful candidate will be responsible for planning and conducting audits against the manufacturing of medical devices, in accordance with ISO 13485, MDD 93/42/EEC, and MDSAP standards, enabling the delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards.

 

Key Accountabilities


  • Conduct audits (either desk-based or on client’s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
  • Conduct Technical File reviews specific for products being authorized.
  • Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.
  • Complete specific projects in relation to medical device procedures, processes, systems and documentation as requested by the Medical Devices Operations Manager.
  • If required, undertake reviews of packs and make certification decisions within target timescales and in line with SGS policies and accreditation/approval requirements.
  • Project manage auditing teams, as appropriate, to maximise efficiencies, enhance client satisfaction and ensure compliance with standards.


YOUR PROFILE


  • Excellent working knowledge of ISO 13485, MDD 93/42/EEC.
  • Good manufacturing and technical knowledge of electro-medical devices (active devices); and their relevant harmonized standards.
  • Experience of conducting MDSAP audits or standalone Technical file reviewer would also be advantageous. 
  • Fully qualified Medical Device Lead Auditor working for a notified body, or as a Technical File reviewer or as a mixture of both.   
  • Strong background in the Medical Device industry, and extensive experience working in a medical device related industry or activities including the relevant production technology. This must include at least 2 years in a technical, quality or manufacturing role; the application of the device in health care services with patients; testing devices; performance testing, evaluation studies or clinical trials of devices.
  • Must be able to demonstrate an excellent working knowledge of medical device management systems, standards and medical device compliance/auditing techniques.  
  • Bachelor's degree in a relevant technology or equivalent tertiary qualification, for one or several technologies used in the medical device sector.
  • Lower level tertiary qualifications supported by a minimum of 8 years’ experience in the technical field will also be considered.


ABOUT SGS


SGS is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. Trusted all over the world, SGS is a market leader because we put 100% passion, pride and innovation into everything we do. We encourage new ideas. We welcome people who challenge the way we do things. And we will be 100% committed to helping you reach your full potential.


 


At SGS, we have an open corporate and international culture, we offer a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and we are committed to supporting your development within the company. 


 #LI-SGSCH


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