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Quality Engineer II

  • Location:

    Tipperary

  • Contact email:

    jsimilak@sigmar.ie

  • Sector:

    Engineering

  • Contact phone:

    +353214315770

  • Job type:

    Full Time

  • Job ref:

    JSiQEBS1509

  • Salary:

    €40,000 - 50,000

  • Published:

    13 days ago

  • Contact email:

    jsimilak@sigmar.ie

Job description

About Your New Employer:

  • You have a chance to work with a leader in medical devices manufacturing.
  • Company passionate about changing people's lives. 
  • Training and development opportunities. 
  • Great work-life balance.

About Your New Job:

As a Quality Engineer II you will be responsible for: 

  • Supervision of Quality Technicians.
  • Driving and implementing process and quality system improvements.
  • Providing effective and responsive QA support to Operations.
  • Ensuring all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA’s).
  • Ensuring Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
  • Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
  • Approval of change requests for product, process and quality system changes.
  • Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
  • Validation: Define process, product and test method validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
  • Compilation of required Regulatory documentation.
  • MRB: Review of MRB trends and identification of appropriate corrective actions when required.
  • Performing internal quality audits.
  • Supporting the implementation of Lean Manufacturing across the site.
  • Transfer and implement product and processes from development or from another manufacturing facility.

What Skills You Need :

  • Minimum of Bachelor of Science Degree in Engineering/Technology
  • 2+ years experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated).
  • Experience in the medical device industry is an advantage.

What’s on Offer:

  • Industry leading package: competitive salary, health care and pension. 
  • Good work-life balance: sociable hours. 
  • Fantastic progression opportunities.
  • Defined career path. 

What's next:

Hit 'Apply Now' or for a confidential discussion about this please reach out to Jakub on 021 2359 140 or jsimilak@sigmar.ie

Why Apply Through Sigmar?

  • We’ll help manage your job hunt, strengthen your interview skills and tidy up your CV
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