Loading...
Share this Job
Apply now »

Senior R&D Quality Engineer (Design Assurance)

Requisition ID:  35972
Date:  Sep 27, 2021
Location: 

Dublin, Leinster, IE

Department:  Quality

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

Job Summary:

Reporting to the Design & Quality Assurance Manager, this role will support West proprietary design & development projects with key focus and responsibility around the interpretation, application of and compliance to FDA Code of Federal Regulations Part 820, EU Medical Device Regulation 2017/745, ISO 13485 Clause 7.3 and internal procedures. The Senior Quality Engineer (Design Assurance) will manage the quality aspects of West proprietary design & development projects; will provide West proprietary design & development teams with guidance on design quality-related issues and design control best practice; and drive a culture of compliance and continuous improvement within West proprietary design & development teams.

 

Essential Duties and Responsibilities:

  • Program Activities:
    • Responsible for ensuring proprietary design & development projects are executed in compliance with relevant regulations; international standards; and enterprise and local procedures.
    • Report on the progress of projects; identify successes; and drive compliance.
    • Escalate quality-related issues to the Design & Quality Assurance Manager, as required.
    • Review and approve relevant design history file documents; device drawings; device specifications; procedures.
  • Risk Management Activities:
    • Responsible for generating the Risk Management Plan and Risk Management Summary Report on proprietary design & development projects.
    • Facilitate risk assessment meetings with proprietary design & development teams.
    • Facilitate project risk register meetings and ensure these risk registers are maintained and updated by the relevant program manager or designee.
  • Validation Activities:
    • Review and approve validation documents (protocols & technical reports).
    • Facilitate and support the completion of the pre-PQ checklist.
  • Metrology Activities:
    • Review metrology data and report to the design & development teams during OQ & PQ.
    • Support Quality Function Deployment activities (QFD).
  • QMS Activities:
    • Drive the closure of change controls and protocol deviations.
    • Review and draft relevant procedures and forms for the management of activities connected with product design & development.
    • Perform first article component and products inspections
    • Draft defect libraries and QSS documents during OQ; and manage formal hand over of same to Operational Quality prior to PQ.
    • Support the supplier selection process in accordance with West supplier management procedures.
    • Conduct internal and supplier audits
    • Support in the preparation and hosting of third party and customer audits.
  • Compliance to all enterprise and local company policies and procedures.
  • Act in accordance with the company’s Guiding Principles and adherence to the corporate Code of Conduct.
  • Compliance to all site Environmental, Health and Safety requirements, training, and regulations.
  • Compliance to all local site company policies, procedures, and corporate policies.
  • Perform additional duties at the request of the direct supervisor.

 

Basic Qualifications: 

  • Minimum requirement: Degree in a relevant Science, Engineering or Quality discipline with at least 5 years working in a high-volume manufacturing environment, ideally in the Medical Device / Pharmaceutical sectors.

 

Preferred Knowledge, Skills and Abilities:

  • Must have practical experience working with design teams and providing design assurance support according to international regulatory requirements.
  • Working knowledge of EU MDR 2017/745, ISO 13485, ISO 14971 and 21 CFR Part 820 is essential.
  • Working knowledge of 21 CFR Part 210 / 211 would be considered an advantage.
  • Risk Management experience within design and development with a good working knowledge of ISO 14971.
  • An excellent understanding of plastic process manufacturing, computer systems validation, analytical methods and testing and documentation systems.
  • Knowledge of analytical tools and methods, including statistics (Minitab preferred).
  • Must be able to organise and prioritise tasks, must be detail orientated and self-motivated.
  • Must have excellent written and verbal communication skills.

 

Physical & Travel Requirements:

  • Must be able to travel as required by the position.

 

Delegation of Duties

When absent from the site duties and responsibilities will be delegated to the following designates

 

 

 

 

 

 

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to kimberley.eby@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

Apply now »