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Senior Quality Engineer

ID
14326
Location
Galway
Role Type
Permanent
Contact
Mark Wilson
Email
talent@hero.ie
Phone
+353 86 0449473
LinkedIn
click here
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Senior Quality Engineer

HERO Recruitment are excited to share that we are recruiting for a Senior Quality Engineer to join our Client’s team in Galway. Reporting to the Director of Quality, the Senior Quality Engineer will oversee critical KPIs across the business unit and drive QA initiatives throughout the business.

Our Client are open to candidates with strong experience in a regulated manufacturing facility and coming from either an operations or projects background.

Key Responsibilities:

  • Deliver on all KPIs that help the business achieve its goal and have primary responsibility for specific KPI’s for the business area.
  • Lead and drive QA initiatives within area of functional responsibility.
  • Provide technical support to the Quality Technicians
  • Provide Quality input and support to the Manufacturing, Engineering, Prototype and Commercial functions.
  • Lead, coordinate & maintain risk assessment documentation e.g. FMEA’s, for their assigned product(s)
  • Investigate root cause of Quality issues and following through with timely and effective corrective actions to prevent re-occurrence for customer and internal issues.
  • Strategically lead new product introduction and contract reviews from a QA perspective where assigned
  • Lead assigned projects from a quality perspective including process improvements, SCN’s, Notification of Changes, Contract Reviews and alternative materials.
  • Prepare and updating Operations procedures and associated documentation.
  • Responsibility for assigned functional area GMP standards and compliance including the promotion of Quality awareness.
  • Establish inspection standards, sampling plans, and test methods.
  • Report Quality metrics.
  • Develop strong links with customer organisations and other project stakeholders.
  • Quality review of functional area validation documentation.
  • May have responsibility to manage the day to day activities of inspector or student level resources in a safe environment and be responsible for Health and Safety goals.
  • Perform and support internal and external audits to ISO and FDA requirements.
  • Perform an active role in further development and continuous improvement of the Quality Management system.
  • Other tasks as directed by the Operations Quality Manager or Quality Supervisor in line with company goals and objectives.

Key Requirements:

  • Level 8 degree in Science / Engineering or related fields.
  • Minimum of 5 years Quality Engineering experience with 4 Years industry experience in a medical device manufacturing environment
  • Experience in CAPA.
  • Experience in root cause analytical and problem-solving skills.
  • Knowledge of FDA and ISO Quality systems for Medical device companies desirable.
  • New product introduction and manufacturing process transfer experience desirable.
  • Test method and process validation experience

For further information on this role in please contact Mark Wilson on 0860449473 or email talent@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

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