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Design And Compliance Quality Engineer

Employer
Actalent
Location
Dublin
Salary
Not Specified
Start date
4 May 2023
Closing date
1 Jun 2023

View more

Discipline
Quality, GMP, QA / QC
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)

Job Details

We have a Brand New Design Quality Engineer opportunity that has just opened for a rapidly growing pharmaceutical company!

We are looking for someone to come and join a pharmaceutical company based in Dublin, Ireland on a 12 month contract. This will be an outside IR-35 opportunity. The desired candidate is expected to be on site 3 days a week and will have the following responsibilities:

  • Support new product design and development, design transfer, design validation, design review, risk management, etc. working closely with Device Engineering
  • Design control compliance ensuring consistent, workable and compliant planning, development, testing, and change management;
  • Regulatory compliance: ensuring product development and maintenance in accordance with FDA QSR's
  • Design risk management, etc. for all programs and projects, compliant with regulatory standards (ISO/EN 14971)
  • Interact with other functions where necessary
  • Supplier qualification, vendor management and performance evaluation
  • Monitor and ensure the timely closure of CAPA, Management of Change (MOC) records, internal audit, and regulatory findings.
  • Track and trend quality system metrics
  • Support preparation for management reviews, internal audits, and external agency audits.
  • Other tasks deemed necessary by the Quality Manager

We are ideally looking for the following experience:

  • Bachelor degree in science, microbiology, engineering or equivalent technical field
  • 5+ years of cGMP experience
  • Experience in medical device design control and product realization
  • Knowledge of medical device regulations including FDA, GMP, design controls, ISO 13485, EU MDR, IEC 62304, ISO 14971, etc.
  • Competence in statistical tools including design of experiments and sampling methods
  • Experience in design quality assurance, risk management
  • Problem solving skills e.g root cause analysis and CAPA implementation

If you think this could be the next role for you then please do not hesitate to apply!

Job Title: Design Quality Engineer

Location: Dublin, Ireland

Contract Type: Full-time, Temporary (12-month contract)

Daily Rate: Competitive, dependent on experience

Job Title: Design And Compliance Quality Engineer

Location: Dublin, Ireland

Job Type: Contract

Trading as Aerotek. Allegis Group Limited, Maxis 2, Western Road, Bracknell, RG12 1RT, United Kingdom. No. 2876353. Allegis Group Limited operates as an Employment Business and Employment Agency as set out in the Conduct of Employment Agencies and Employment Businesses Regulations 2003. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, Talentis Solutions, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available at https://www.allegisgroup.com/en-gb/privacy-notices.

To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to https://www.allegisgroup.com/en-gb/privacy-notices.

We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice at https://www.allegisgroup.com/en-gb/privacy-notices for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield

Company

About Actalent

Actalent connects passion with purpose. Our scalable services and talent solutions drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world.

 

Actalent’s global footprint and flexible delivery models ensure access to specialized talent where and when you need it. We promote consultant engagement through professional development and provide experiences to ensure continuous learning. Our people are the difference.

 

Our expertise spans capabilities in engineering including product and manufacturing, systems and software, construction management, environmental, architecture and civil; and power and utilities. We focus on sciences capabilities in laboratory sciences, healthcare, and clinical research.

 

Actalent is an operating company of Allegis Group, the global leader in talent solutions.

Company info
Website
Telephone
+44 0 1344 383 100
Location
Maxis 2 ,
Western Rd
Bracknell
Berkshire
RG12 1RT
GB

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