Senior Design Quality Engineer

  • Job Reference: 16377
  • Date Posted: 12 May 2022
  • Recruiter: Waters
  • Location: Wexford
  • Salary: On Application
  • Sector: Engineering, Engineering > Chemical Engineering, Engineering > Computer Engineering, Engineering > Electrical Engineering, Engineering > Industrial Engineering, Engineering > Mechanical Engineering
  • Job Type: Full Time Flex
  • Work Hours: Full Time

Job Description

Overview

An exciting opportunity to become part of a dynamic team responsible for the R&D of IVD products. The person will have a strong understanding of the requirements and implementation of QMS ISO 13485 & 21CFR820. The design quality engineer will provide functional expertise in Design Assurance and Risk Management activities in conjunction with the development teams.

Responsibilities

The successful candidate will:

  • Provide functional expertise to R&D, Reagent Kit Development team and other stakeholders
    during the design & development of IVD products and for on-market product design changes.
  • Preparation of design control planning, design input, design output, design transfer and
    traceability documentation.
  • Lead product development team risk management activities
  • Review and approval of verification and validation testing protocols and testing reports to
    ensure they are accurate, complete & compliant.
  • Review and approval of developmental and on-market product stability protocols and reports.
  • Preparation of technical documentation and other regulatory documentation, as required.
  • Provide support on generation and approval of product end user labelling.
  • Review and approval of design changes / ECRs / deviations (Internal and Supplier) to ensure
    compliance with Waters QMS and regulatory requirements.
  • Creation & maintenance of raw material/component/product specifications.
  • Review and approval of ECRs for development and on market product raw materials,
    packaging and component specifications.
  • Be a point of contact for design related queries for development personnel.

 

In return you will receive:

  • Learning and development opportunities to further your career.
  • Competitive salary
  • Private health insurance
  • Life and long term disability insurance
  • Company pension contributions
  • EAP program

Qualifications

  • Minimum of 3 years previous industrial experience of working as a Quality Engineer or Quality
    specialist in an ISO 13485, ISO 9001, cGMP (21 CFR Part 820) design or manufacturing
    environment. Previous quality professional experience within a Pharmaceutical environment may
    also be considered.
  • Preparation of documentation to support regulatory filings.
  • Analytical Method, Equipment and Process Qualification.
  • Non-Conformance / CAPA Management.

Experience Desired:

  • Product development and design assurance experience
  • Risk analysis techniques.
  • Product release and QC laboratory (Clinical or Other) experience

Company Description

Waters Corporation (NYSE: WAT), the world's leading specialty measurement company, has pioneered chromatography, mass spectrometry and thermal analysis innovations serving the life, materials, and food sciences for more than 60 years. With more than 7,000 employees worldwide, Waters operates directly in 35 countries, including 15 manufacturing facilities, with products available in more than 100 countries. Our team focuses on creating business advantages for laboratory-dependent organizations to enable significant advancement in healthcare delivery, environmental management, food safety, and water quality.   

 

Working at Waters enables our employees to unlock the potential of their careers. Our global team is driven by purpose. We strive to be better, learn and improve every day in everything we do. We’re the problem solvers and innovators that aren’t afraid to take risks to transform the world of human health and well-being. We’re all in it together delivering benefit as one to provide the insights needed today in order to solve the challenges of tomorrow.