Quality System Engineer

Palliare | Careers

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Job Summary:

Manage key elements of the Quality System to ensure compliance to relevant standards for the business including EN ISOI 3485:2016, MDSAP and FDA requirements. The role will take the lead in ensuring that the quality system is maintained and implemented in a compliant manner and areas of improvement are identified and implemented as required. This will involve coordinating and working with all functions in a collaborative manner where quality system compliance is dependent.

Job Responsibilities/Duties:

  • Coordinate the Internal Audit system and Audit Team to ensure that all audits are completed in a thorough and timely manner. Conduct Quality Audits as necessary.
  • Lead preparation and coordination activities for external audits and liaise as required with SME’s to ensure audits are conducted in an efficient manner.
  • Co-ordinate the Document Control Function in conjunction with the appropriate resources.
  • Identify and initiate action to address any adverse trends or regulatory compliance issues in a timely manner.
  • Coordinate the Non-Conforming and CAPA system to ensure that all NC/CAP As are completed in a thorough and timely manner.
  • Assist with Management review planning and execution.
  • Promotes the awareness of regulatory and customer requirements throughout the organization.
  • Supports Quality training on site.
  • Methodical review approach and be capable of initiating and leading change and continuous improvement.
  • Other project work as assigned by the Quality Systems Manager.

Education/Experience:

  • A degree in Engineering, Technology, or Science.
  • At least 3-5 years’ experience working in a regulated medical device or pharmaceutical company.
  • Excellent verbal and written communication skills.
  • Excellent planning and coordination skills.
  • Excellent attention to detail skills

Specific Requirements::

  • Ability to work within a team environment to achieve agreed company goals.
  • Ability to communicate quality / regulatory concepts effectively.
  • Excellent understanding of EN ISO 13485:2016, MDSAP ad FDA regulations.
  • Formal Audit Training.
  • Proficiency in use of desktop software applications such as MS office.
  • Some travel may be required with the role.
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