Quality Systems Engineer


Job Detail

Location Drogheda
Salary Negotiable
Role Type Permanent
Contact Nela Dobrusova
email Medtech@hero.ie

Quality Systems Engineer

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Job ID: JOB-13344
Job Description


Reporting to the Quality Systems Leader, duties will include implementing & maintaining the Company’s Quality Management System in accordance with applicable standards and regulations.


  • Provide support for the key elements of the Quality Management System (QMS), which includes, but not limited to: CAPAs, Internal Audit Program, Complaints, Change Control, QMS deviations, QMS documentation, policies, and GMP / Behavioural Based Quality.
  • Manage and provide guidance on Data Strategies for Change Control process
  • Actively supports site CAPA system, mentors associates on CAPA process, co-ordinates preparation of data for CAPA review Meetings etc.
  • Actively supports internal audit program for the site and identify areas of potential noncompliance or improvements.
  • Be a primary contact to other departments such as engineering and operational functions to provide assistance and support on quality system requirements
  • Responsible for ensuring adherence to internal and external regulatory requirements
  • Be a key member of the onsite audit team during external audits, e.g. from Regulatory Authorities and Global Corporate Quality.
  • Assist and facilitate Complaint investigations ensuring effective root cause analysis and assigning of appropriate CAPAs. Ensure appropriate
  • Risk Management activities are completed at all stages of CAPAs, CAPA Initiation (CID), Complaints and Quality Notifications
  • Assist and co-ordinate the preparation of data for Management review Meetings for all products manufactured on site.
  • Assist and co-ordinate implementation of global standards and corporate procedures into the site Quality Systems.
  • To actively support the development/implementation and continuous improvement of the Quality Management Systems.
  • To be cross trained in multiple quality systems.
  • Develop and write SOP & Controlled Documents.
  • Continuously review and improve quality documentation including, SOPs, Policies, Guidelines, Specifications, Investigations, Complaints, GMP records and other Quality Management System Documentation as required.
  • Participate in other projects as directed by the Quality Manager.
  • Compilation of monthly metrics for Plant management and Unit QA Co-ordinate / generate quality metrics / reports for weekly meetings
  • Where relevant, take ownership of Corrective and Preventive Actions, and track progress through Trackwise or similar e-CAPA systems.
  • Support Quality Engineering / Continuous Improvement activities as required. Ensure adherence to all BD regulatory requirements. Promotion of Quality Awareness, Culture, cGMP and BD Values within the Plant.
  • Training of associates on Quality procedures and initiatives Support third part Audits and Inspections


  • Degree Qualified in Engineering, Science or Quality related discipline.


  • 3+ Years relevant work experience in a regulated medical device or pharmaceutical environment.
  • Proven working experience with FDA QSR and ISO 13485. Strong understanding of change and project management
  • Proven track record in problem solving, root cause analysis and supporting quality notification / CAPA resolution.
  • Ideally Qualified ‘lead auditor’ experience.
  • Six Sigma or similar statistical background would be advantageous
  • Experienced in technical writing and review
  • Experience in CAPA system management
  • Proven ability of working in a cross-functional team environment.
  • Excellent interpersonal and communication skills and high level of computer literacy.
  • Good understanding of cGxPs
  • Significant experience working within an established Quality System

For further information on this role in please contact Nela Dobrusova on 0861283369 or email medtech@hero.ie.

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

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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.

Nela Dobrusova


Apply Now

Quality Systems Engineer

Nela Dobrusova

Role Type Permanent
Contact Nela Dobrusova
email Medtech@hero.ie
mobile +086 1283369
linkedIn profile click here

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