QA Validation Engineer
A leading company in the medical device industry, dedicated to making a positive impact on people's lives have a new opening for a QA Validation Engineer to join the team. Their commitment to innovation, quality, and dignity drives them to deliver exceptional products.
As a QA Engineer, you will play a vital role in ensuring the highest standards of quality engineering for our their Plant Value Stream, specifically focusing on Continence Care products. Your expertise will contribute directly to the growth and profitability of our organization. This is a unique opportunity to be part of a dynamic team that values innovation, teamwork, and continuous improvement.
Responsibilities:
Developing and implementing Master Validation Plans and Risk Assessments for the Value Stream.
Leading Quality Engineering activities within the Value Stream, including the development and completion of DV/IQ/OQ/PQ protocols.
Collaborating with our New Product Development (NPD) personnel to develop product specifications, drawings, and quality plans.
Providing QE support for NPD projects, ensuring that our new products meet the highest quality standards.
Conducting Process Risk Management and FMEA activities to identify and address potential issues.
Performing internal audits as per the audit schedule to ensure compliance with quality standards.
Coordinating and executing process capability analysis on catheter processes to optimize efficiency and quality.
Investigating and resolving CAPA (Corrective and Preventive Action) items to drive continuous improvement.
Leading audits for the department, reinforcing our commitment to excellence.
Qualifications:
A degree in Engineering/Science Discipline and a Quality Engineering Qualification.
Proficiency in statistical analysis, SPC (Statistical Process Control), and validation of automated equipment.
At least 5 years of experience in the Medical Device Industry, with a focus on utilizing automated equipment.
A Master's degree in Engineering/Science Discipline will be considered an advantage.
This role is very well remunerated with competitive basic salary, company pension plan, full private family healthcare, annual bonus etc. Its an employee-owned global business which results in a thriving and enriching work environment that fosters collaboration, creativity, and mutual respect. The company is known for its work-life balance and flexible hybrid working policy.
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For a confidential discussion and more information on the role, please contact Davin Ferguson
davin.ferguson@collinsmcnicholas.ie
071 9140251