Quality Engineer II- Cork | Collins McNicholas

Quality Engineer II- Cork

  • Reference: CJ45126
  • Job Type: Permanent
  • Location: Cork, Cork City, Munster
  • Category: Science, Pharmaceutical & Food

Key Responsibilities:

  • Supervision of Quality Technicians and QC Inspectors.
  • Drive and implement process improvements to ensure predictable processes across all product lines (e.g. Risk Reduction, Yield improvements, Customer complaint reduction, Error proofing, Cost Reduction initiatives, Process Automation activities).
  • Provide effective and responsive QA support to Operations to meet their area’s objectives of quality, cost and output.
  • Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA’s).
  • Drive and implement plant wide quality system improvements.
  • Ensure Regulatory compliance in area of responsibility to cGMP’s of all medical device regulatory agencies (e.g. FDA and TUV).
  • Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
  • Identification and implementation of appropriate statistical techniques to monitor process performance (e.g. SPC, CpK analysis, sampling techniques).
  • Approval of change requests for product, process and quality system changes.
  • Customer complaints: Analysis of returns, approval of analysis reports and analysis of complaint trends.
  • Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
  • Compilation of required Regulatory documentation (e.g. Technical files, Design Dossiers, Product transfer files, Essential requirements).
  • MRB: Review of MRB trends and identification of appropriate corrective actions when required.
  • Perform internal quality audits.
  • Support the implementation of Lean Manufacturing across the site.
  • Transfer and implement product and processes from development or from another manufacturing facility.

 

Educational Requirements:

  • Minimum of a Bachelor of Science Degree in Engineering/Technology.
  • 3/4 years of experience in a manufacturing environment or equivalent with direct experience in a QA environment (preferably GMP regulated). Experience within a Med Device/Pharma environment i.e. FDAISO 9000 necessary.
  • Demonstrate strong leadership skills and promote quality at source
  • Develop plans and execute on time to these plans
  • Strong Project Management skills combined with proven consistent execution within committed quality, time and cost targets.
  • Experience/training in problem solving and process improvement methodologies (Engineering Essentials TM).

 

 

For a confidential discussion and more information on the role, please contact Eloísa Ruiz on 021 4911063 or email eloisa.ruiz@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, our job searching tips & videos!


Firstname (required)

Surname (required)

Your Email (required)

Your phone

Upload CV (required)

Security Code captcha

Comment

Contact Consultant

  • Eloísa Ruiz
  • Recruitment Consultant
  • 021 4809 118
  • Connect with Eloísa
Request a Call Back

Jobseekers Guide – CV’s

CV animation
WRITING YOUR CURRICULUM VITAE What is the purpose of a CV?  A CV is the first thing you think of when applying for a job, and people often wonder what an employer looks for in a good one. Your CV gives you the chance to tell the employer all about yourself and what you have […]
read whole article

Jobseekers Guide – Cover Letters

FB 1200x630 (1)
Jobseekers Guide – Cover Letters Cover letters are a basic requirement for most jobs, which is why it is so important to know exactly what a good one looks like. There are many examples on our website but here is a brief guide to prepare the perfect cover letter and CV for any job: Writing a Good […]
read whole article

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