Senior Quality Engineer

Contact Paul Cullen
  • Salary: €55,000 - €65,000
  • Location: IrelandMunsterLimerick
  • Sector: Pharma & Life SciencesAdvanced Manufacturing
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Job description

Sonas Technical are currently on the lookout for a Senior Quality Engineer for our client, a Global provider of Medical Technology. The successful person will receive a strong remuneration package and be based in our clients Limerick site.

The role requires strong quality leadership across multiple business elements, driving Quality for products, processes and/or systems. Implementing QMS and Customer requirements throughout product life cycle from NPD, NPI through to End of Life. Requiring effective control over quality, documentation and communication with all stakeholders throughout the process. Ensuring compliance within the Value Stream to all QMS and GMP requirements.

Why apply with Sonas?

  • We can provide insights to the best salaries, rates and benefits on offer
  • One point of contact – We can manage all your applications, interviews and negotiations
  • We will get your CV seen by the right hiring managers

Key Responsibilities

  • Excel in technical expertise in the following areas:
    • Specifications & CTQ mapping
    • Test method development & validation
    • Process validations & CCP implementation
    • Error-proofing & SPC for process monitoring
    • Handling complaints & managing non-conformities
    • Conducting risk assessments & investigations
    • Root cause analysis & solution development
    • Planning product testing & release
    • Change management & audit conduct
    • Application of critical thinking & technical writing
  • Lead quality initiatives across cross-functional teams, represent company interests professionally in customer interactions, ensure QMS alignment with customer requirements, drive new product development, and spearhead continuous improvement.
  • Drive Safety/Quality/Service/Cost metrics, align objectives, execute Lean initiatives, coach teams, and build strong stakeholder relationships. Ensure strict regulatory compliance and adherence to QMS, EHS policies.”

Requirements

  • Bachelor’s degree in a Science, Engineering, or quality-related discipline is essential
  • Over 8 years of quality technical experience in a similar environment.
  • Desirable certification as a Quality Engineer (QE).
  • Proficiency in technical report writing.
  • Competency in risk management tools and process validation.
  • Proficiency in structured problem-solving tools.
  • Understanding of Lean Principles, with Lean Six Sigma (LSS) Green Belt certification being desirable.
  • Working knowledge of EN ISO 13485, FDA QSR 21 CFR Part 820, and principles of GMP in the Medical Device Industry.
  • Ability to comprehend customer/vendor relationships.
  • Handling difficult customer or vendor communications.
  • Ability to influence customers/vendors when necessary.
  • Awareness of the impact of the role on key business drivers.
  • Basic understanding of how various departments contribute to the overall business.
  • Effective verbal and written communication.
  • Collaboration within cross-functional teams.

 

To apply, please email your CV to paul.cullen@sonastechnical.com

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