Technical Director, Medical Devices at SGS North America Inc.

Posted in Other 2 days ago.

Location: Rutherford, New Jersey





Job Description:

Company Description



SGS is the world's leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 89,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.



Job Description



The Technical Director, Medical Devices ensures that audit and certification processes, and technical performance levels are managed, maintained and improved in accordance with program objectives, accreditation requirements, non-accredited proprietary program / product requirements, other requirements as applicable, and SGS global and local procedures in the most commercially effective way. They will manage technical aspects and provide technical support to management, staff, clients and others on matters relating to accreditation, changes to standards, procedures, processes, marketing, sales, operations, audit, certification and associated processes, and facilitate continual improvement for new and existing programs / products.


  • Review, update and ensure all parties are aware of the procedure requirements

  • Assist in recruitment by reviewing resumes or CVs and performing technical interview portion

  • Develop new and or existing auditor training plan, on-boarding, procedure training, and calibration

  • Monitor level one audit and review product qualification

  • Qualify and approve technical areas

  • Review technical and make decisions on the certification

  • Review and approve all Proposal Worksheet

  • Review and approve Certification Function Competence Review

  • Perform Level Two audits

  • Attend Accreditation audit and visits

  • Support training new recruits for product knowledge

  • Market product support

  • Support Chargeable audits (when needed, team need to discuss and agree)

  • Sales Support product training

  • Involvement in mini projects and initiatives

  • Oversee auditor KPIs (TRT, Queries, audit quality)

  • Handle and resolve appeal and complaints

  • Continuous improvement for all MIRs

  • Adheres to internal standards, policies and procedures.

  • Performs other duties as assigned.

  • Travels up to 40% of time. Some travel might be international.







Qualifications





  • Bachelor's degree in Sciences AND

  • Minimum 10 years of experiences in the Medical devices industry and minimum 5 years in as lead auditor.

  • Lead Auditor to medical devices certification standard i.e. ISO13485 , MDD 93/42/EEC Part 1 CMDR, JPAL and Australian TGA, MDSAP





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