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Jobs or company...

Senior Quality System Engineer (Medical Device)

Salary undisclosed

Apply on

JobStreet
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Summary Description

  • Overall co-ordinate plant wide activities related to Medical Device Quality Management Systems set up, implementation, maintaining and compliance with accreditation of ISO 13485.
  • Risk Management approach for product development and or product realization.
  • Coordination of Process Validation (process/ software) with cross functional team.
  • Ensure compliance with statutory and regulatory requirements.
  • Responsible for Quality Management System (QMS) and ISO audit.

Specific Duties And Responsibilities

  • Establishing / revising and maintaining of Procedures, Work Instructions, Product /Medical Device File etc. documentations consistent with accreditation of ISO 13485/ ISO 9001 and compliance with statutory and regulatory requirements.
  • Plant wide and inter-company (on needs basis) coordination of the ISO 13485 Quality Management System related processes implementation and compliance.
  • Leading and coordination with relevant departments on implementation of process / product validation, risk assessment etc. related processes accordance with ISO 13485 standards and ISO 14971.
  • Leading periodical internal quality audit of ISO9001 and ISO 13485 to gage the compliance level to ISO requirements and continually improve the effectiveness.
  • Prepare the audit report and follow up close loop corrective actions.
  • Prepare and participate in periodical Management Review.
  • To perform document control function as per ISO procedures (eg: SOP, WI, Records)
  • Liaise with third party auditor in new certification, surveillance, or recertification audit.
  • Any other duties and projects assigned by the Quality Manager and or QA Head Department

    • Requirement

  • Minimum bachelor’s degree, preferable in Science, Engineering, Applied Science or equivalent.
  • Minimum 3 – 5 years of working experience in the QA System field at Manufacturing Environment.
  • Knowledge in ISO 13485 Standard is a must. Familiar with ISO 9001 QMS, 6 Sigma, FMEA, and or quality core tools will be a definite advantage.
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