NPI / Quality Systems Engineer – Galway – Contract | Collins McNicholas

NPI / Quality Systems Engineer – Galway – Contract

  • Reference: GJ43408
  • Job Type: Permanent
  • Location: Galway
  • Category: Engineering, Technical & Manufacturing

As NPI / Quality Systems Engineer  you will primarily be responsible for maintaining and improving where necessary all quality systems and monitoring production process for compliance to implemented process controls for new and existing product and processes in the Galway facility.


  • Ensure continued compliance with all Regulatory Standards. This includes:
    • ISO 13485
    • FDA QSR
    • Ensuring continued compliance with DMR
    • Validations
    • Engineering Change Order (ECO)
    • Failure Mode Effect Analysis (FMEA)
    • Supervision, direction mentoring, performance review, developmental plans of quality technicians
    • and documentation control personnel to ensure compliance for their areas of responsibility.
    • Ensure the company behavioural standards are adhered to, setting the example yourself for your direct reports.
    • Ensure that in your absence your department provides adequate day to day service.  Ensure that other departments know of your arrangements well in advance.
    • Ensuring backup and notification for any absences within the group, and being able to step down when required based on priorities.
  • Responsible for all quality aspects of new product & process introduction including:
  • Responsible for the successful completion of all quality aspects of customer FARFs associated with NPI
  • Management of the CAPA program and compile CAPA metrics & Quality Data Input
  • Act as SME (subject matter expert) with respect to complaint handling.
  • Experienced in management of Document Control.
  • Act as SME with respect to Internal Auditing for the site
  • Assist internal audit team with respect to planning/content of audits/ audit reporting / corrective action plans
  • Management of the supporting elements of the Quality Management system.
  • Takes a leadership role in developing and implementing new techniques and initiatives to enhance the QMS
  • Participates in external regulatory audits
  • Compile monthly Quality Reports.
  • Perform Quality Systems Trending by compiling; monthly quality reports, raw data for Quality KPIs and trending for Operations Reviews and Management Reviews
  • Conduct detailed root cause analysis on design related non-conformances, developing effective preventive measures to prevent recurrence.
  • Playing a role in the plant annual objectives.
  • Project meeting attendance as required.
  • Work efficiently using own initiative, escalating decisions to the Quality and Regulatory Manager as, when, and only when, necessary.


Skills, Experience and Qualifications:

  • Engineering or science Degree preferably with Quality Engineering included.
  • The abilitity to work effectively with close tolerances in a fast paced demanding environment.
  • Ability to communicate and work with people inside and outside the department.
  • Good communicator (written and oral).
  • Ability to train and lead.
  • Ability to multi-task and to work in a high paced environment with an awareness of continued impact on production and the plant performance
  • Good presentation skills to conduct training and presentations
  • Knowledge of engineering theories and methods.
  • Good technical report writing skills.
  • Rigorous attention to detail.


For a confidential discussion and more information on the role/company please contact Christopher O’Toole on 091-706713 or email

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website

Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs as well as our job searching tips and videos!

Firstname (required)

Surname (required)

Your Email (required)

Your phone

Upload CV (required)

Security Code captcha


Christopher O'Toole

Contact Consultant

  • Christopher O'Toole
  • Recruitment Consultant
  • 091 706713
  • Connect with Christopher

Budget Basics 2017

Scales with money
Tuesday afternoon, Ministers Noonan and Donohue presented the budget for 2017 to the Dail. It included a number of expected measures, along with some interesting talking points. It’s very easy to get lost in the stats, but what implications does this really have? At a breakfast briefing this morning, hosted by RBK, Ulster bank and […]
read whole article

The Olympic Recruitment Race

business man running on s track, blog 800 x 450
    The repetitiveness of applying for jobs continuously can sometimes feel like running a marathon; drawn-out, tiring, painstaking and seemingly never-ending. However, using the right tools and going about it the right away can turn a marathon into a 100 metre sprint. Preparation Have an up to date CV and cover letter ready to […]
read whole article

Job Seekers Guide

Everything you need to know to find a job, including; how to prepare a CV and cover letter, how to prepare for a job interview, how to navigate the modern job market, and much more.
view more