Collins McNicholas

 ESSENTIAL JOB DUTIES AND RESPONSIBILITIES

Ensure continued compliance with all Regulatory Standards. This includes:

    • ISO 13485
    • FDA QSR
    • ISO 14000
  • Monitor production process for compliance to implemented process controls to ensure quality product is shipped to customer and provide:
    • Trend analysis of data from the controls
    • Potential improvements for review with engineering based on the trends.
  • Areas for Improvement to senior management.
  • Review and propose changes to sampling plans based on trend analysis and changes to the system.
  • Ensure that in your absence, your area of responsibility is covered.  Ensure that other departments are informed of your arrangements.
  • Support the Complaint/CAPA meetings to ensure that internal and customer concerns are handled and dealt with in an appropriate manner.
  • Execution of Quality Validations and preparation of associated documentation as required.
  • Review, update and approve Quality procedures as required through ECO process.
  • Action NCR and CAPA in an appropriate and timely manner.
  • Raise appropriate Variation Permits as required, in line with customer and regulatory requirements.
  • Support Customer and Regulatory Audits.
  • Review and ensure that area of responsibility documents listed below are approved in an appropriate and timely manner.
    • Validations.
    • Engineering Change Order (ECO).
    • Complaint/Corrective and Preventative Action (CAPA).
    • Material Review Request (MRR).
    • Internal Audits.
    • Failure Mode Effect Analysis (FMEA).
    • Variation Permits (VP).
  • Project meeting attendance and provision of quality support as required.
  • Attend and participate in daily cell meetings.
  • Preparation of information for KPI and Management Review meetings.

 

 

SKILLS AND KNOWLEDGE:

 

  • Ability to communicate and work with people inside and outside the department.
  • Good communicator (written and oral).
  • Ability to train and lead where required.
  • Ability to co-ordinate, plan and organise in a timely manner.
  • Knowledge of engineering theories and methods.
  • Good technical report writing skills.
  • Rigorous attention to detail.

 

MINIMUM EDUCATION AND EXPERIENCE REQUIREMENTS:

 

  • Engineering or science Degree preferably with Quality Engineering included.
  • Quality Department or similar experience in regulated industry.

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