Quality Engineer NPI | Collins McNicholas

Quality Engineer NPI

  • Reference: AJ44953
  • Job Type: Permanent
  • Location: Galway, Offaly, Westmeath
  • Category: Engineering, Technical & Manufacturing

Providing Quality support to processes, materials, and products. Assuring Quality standards are maintained and assist with the implementation of and compliance to the Quality Management program and for Supporting company goals, objectives, policies, procedures, quality systems, and FDA regulations.

  

QA Engineer NPI responsibilities:

  • Liaise with Manufacturing Engineering on the completion of risk assessment, Work Instructions, Validations and FMEA’s for both  new product introductions and existing product line changes/process improvements.
  • Review and/or develop and execute facility, software, process and equipment validations and risk management documents
  • Review change controls for process/design impact.
  • Provide quality support to Manufacturing Engineering with sampling plans, data processing or analysis for validation for new and existing product lines.
  • Assist in the analysis and resolution of problems that may reduce the efficient running of production lines.
  • Complete NCMR and CAPA investigation, processing and disposition.
  • Ensure continuous compliance for Product Manufacturing, Packaging and Labeling.

 

 NPI Quality Engineer Requirements:

  • Level 8 Degree in Engineering or Science.
  • Five (5) years experience working in a regulated environments, specifically medical device, FDA or ISO 13485 registered work environments.
  • Strong computer skills (MS Excel, PowerPoint, Word etc)
  • Familiarity with statistical tools such as Pareto charts and trend charts.
  • Familiarity with all aspects of Process Validation (IQ / OQ / PQ)
  • Familiarity with FMEA’s (Failure Mode and Effects Analysis) and root cause analysis tools.
  • Experience with problem solving technique

 

 

For a confidential discussion and a more detailed job description (or more information on the role), please contact Tina Egan on 09064 78104or email tina.egan@collinsmcnicholas.ie

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 www.collinsmcnicholas.ie

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

Comment

Tina Egan

Contact Consultant

  • Tina Egan
  • Recruitment Consultant
  • 09064 50663
  • Connect with Tina

Job Seekers Guide

cmcn_hr_color
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