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QMS Quality Engineer

  • Location:

    Cork

  • Contact email:

    jsimilak@sigmar.ie

  • Sector:

    Engineering

  • Contact phone:

    +353214315770

  • Job type:

    Full Time

  • Job ref:

    JSiQMSBS0306

  • Salary:

    Negotiable

  • Published:

    14 days ago

  • Contact email:

    jsimilak@sigmar.ie

Job description

Are you a motivated Quality Engineer with expertise in QMS ready to step into medical devices environment?

Job Responsibilities: 

  • Review and approve reports, procudures and validation documents in support of establishing pharmaceutical quality system to GMP requirements. 
  • Subject Matter Expert regarding Acceptable Quality Standards and GMP practices for products and processes.
  • Provide QA support to Operations to meet their area’s objectives of quality, cost and output.
  • Evaluate quality events ensuring compliance with cGMP and quality standard requirements.
  • Support root cause analysis, product impact assessments and corrective and preventative actions (CAPAs) for quality events. 
  • Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed.
  • Ensure Regulatory compliance in area of responsibility for GMP pharmaceutical regulatory agencies (FDA, HPRA etc.)
  • Provide functional expertise to other support functions on quality related issues.
  • Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
  • MRB: Review of MRB trends and identification of appropriate corrective actions when required.
  • Support the implementation of Lean Manufacturing across the site.

Job Requirements: 

  • 2+ experience in Manufacturing or Quality, particularly in relation to pharmaceutical quality systems.
  • Level 8 qualification in Engineering or related technical/Quality discipline.
  • Demonstrated ability to work with cross functional organizations in a dynamic manufacturing environment to solve problems
  • Strong command of MS Office – Word, Excel, PowerPoint.
  • Experience in the pharmaceutical industry and GMP manufacturing
  • Working knowledge and understanding of FDA, HPRA, and the pharmaceutical industry quality requirements.
  • Experience in problem solving and process improvement methodologies
  • Process Validation, Risk Management, CAPA experience.

For a confidential discussion on this or any other job opportunities please contact Jakub on 021 2359 140 / jsimilak@sigmar.ie

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