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Quality Assurance Specialist

2 months ago

HambleleRice, Hampshire, United Kingdom Excelitas Canada Inc. Full time
Job Title: Quality Assurance Specialist

Excelitas Canada Inc. is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality team, you will be responsible for ensuring that our products and business systems meet regulatory and customer quality standards.

Key Responsibilities:
  • Lead and support development and maintenance of business systems, procedures, and documentation
  • Conduct internal audits throughout the audit cycle and drive associated improvement activities
  • Provide Quality Engineering support to manufacturing to maintain OTD and Quality requirements
  • Manage and drive all Material Review Board (MRB) life cycle processes, including investigation and disposition
  • Lead Root Cause Analysis and Corrective Action (RCCA / CAPA) methodologies, such as DMAIC, 8D, 5W & 6M, etc.
  • Support design & development activities, assist Engineering teams to ensure that designs are appropriately reviewed, verified, and validated throughout the development process
  • Participate in the development and refinement of Design and Process FMEA's (Failure Mode and Effects Analysis)
  • Generate and maintain documentation, such as SOP's, calibration, test procedures, and Inspection and Control Plans
  • Conduct statistical analysis, including Statistical Process Control (SPC) or Measurement Systems Analysis (MSA)
Requirements:
  • Experience in a Quality Engineering / Assurance role in a relevant manufacturing industry
  • HND / BTEC / NVQ Level 4 in Engineering or Quality
  • ISO 9001:2015 Internal Auditing qualification and internal auditing experience
  • Good working knowledge of ISO9001:2015
  • Experience of CI Methodologies (5S, LSS, etc.)
  • Experience of working with customers and suppliers
  • Knowledge of 8D problem-solving, RCCA tools, as well as APQP, PPAP, and FMEAs
  • Ability to write and submit Quality reports and familiar with Material Review Board (MRB) processes
  • Experience of working with ERP systems
  • Good working knowledge of Microsoft Office Tools
  • Able to interpret manufacturing documentation

This role is responsible for ensuring that product and business system processes meet regulatory and customer quality standards. The successful candidate will possess the necessary skills and experience to work in a team environment to develop and implement quality best practices and support continuous improvement.