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Senior Quality Engineer

  • Location:

    Cork

  • Contact email:

    Sheldut@sigmar.ie

  • Sector:

    Engineering

  • Contact phone:

    +35321235914

  • Job type:

    Full Time

  • Job ref:

    SHSQEBSCI1001

  • Salary:

    Negotiable

  • Published:

    29 days ago

  • Contact email:

    Sheldut@sigmar.ie

Job description

About Your New Employer

Our client draws the strength from the unique talents and abilities inherent in a diverse workforce and we believe that the best and most innovative products come from an inclusive workplace where varied viewpoints are welcomed and encouraged.

About Your New Job

  • Supervision of Quality Technicians and Quality Engineers.
  • Provide effective and responsive QA support to Operations to meet their area’s objectives of quality, cost and output.
  • Ensure all process variables and their interactions are adequately defined. 
  • Drive and implement plant wide quality system improvements.
  • Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies 
  • Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
  • Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
  • Customer complaints: Approval of analysis reports and analysis of complaint trends.
  • Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
  • Compilation of required Regulatory documentation (e.g.Technical files, Design Dossiers, Product transfer files, Essential requirements).
  • MRB: Review of MRB trends and identification of appropriate corrective actions when required.
  • Perform internal quality audits.
  • Support the implementation of Lean Manufacturing across the site.

 

What Skills You Need  

  • Requires a minimum level 8 qualification in a relevant Engineering / Science degree.
  • Excellent interpersonal and communication skills.
  • Excellent analytical and problem-solving skills.
  • Demonstrated decision making skills.
  • Minimum of 4+ years’ experience within a manufacturing environment.
  • People management experience is advantageous.
  • Strong knowledge of quality principles and the ability to utilize these methods in a manufacturing environment.

What’s on Offer

  • Permanent position
  • Excellent base salary +  10% BONUS, PENSION UP TO 8% + HEALTHCARE + 21 DAYS ANNUAL LEAVE

Given the current climate, Interviews will be conducted remotely via MS Teams.

What’s Next​

For a confidential discussion on this or any other current job opportunity please contact Sylvia Heldut on 087 709 43 55 / sheldut at 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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