Senior Quality Specialist

6 days ago

Waterford, Waterford, Ireland beBeeQualityEngineer Full time €70,000 - €95,000

Job Overview

The role of Senior Quality Engineer is a vital position in our organization. The successful candidate will serve as the QA lead for proprietary design & development projects, ensuring compliance with regulations and standards.

As a key member of our team, the Senior Quality Engineer will be responsible for managing quality aspects, providing guidance on design quality-related issues, and driving compliance within West proprietary design & development teams.

Key Responsibilities:

  • Ensure proprietary design & development projects comply with relevant regulations; regulatory requirements; international standards; and enterprise and local procedures.

  • Identify and support improved quality practices by R&D teams during design control activities; facilitate the integration of quality requirements into design processes.

  • Report on project progress, identify successes, and drive compliance.

  • Escalate quality-related issues to the Design & Quality Assurance Director or designee, as required.

  • Review and approve relevant design history file documents; product drawings; component specifications; labeling; procedures.

  • Support design transfer activities for commercial and launch readiness and sustainment.

  • Review and approve test method validations (protocols and reports); review and approve design verification and design / process validation documents.

  • Facilitate and support project completion up to and including PQ.

  • Author and/or review Risk Management Plans, risk assessments, and Risk Management Summary Reports for proprietary design & development projects.

  • Drive closure of change controls and protocol non-conformance reports (PNRs).

  • Support enterprise procedures updates impacting design and development activities.

  • Lead internal audits of R&D and support site QA in preparing and hosting third-party and customer audits.

  • Actively engage in robust problem-solving to address quality issues.

Requirements:

  • Bachelor's Degree in Chemistry, Engineering, or Quality discipline required.

  • 5 years working in a high-volume manufacturing environment, ideally in the Medical Device / Pharmaceutical sectors.

  • Regulatory Affairs experience is desirable.

  • Working knowledge of ISO 13485, ISO 9001, ISO 15378, and 21 CFR Part 820 is essential.

  • Experience in Project Management, process technology, and elastomers is preferred.

  • Risk Management experience with good working knowledge of ISO 14971.

  • An excellent understanding of rubber and plastic manufacturing technologies, analytical methods, and testing.

  • Knowledge of analytical tools and methods, including statistics (Minitab preferred).

  • Strong written and verbal communication skills, self-motivation, ability to prioritize tasks, and multi-task.

  • Ability to work independently, make sound judgments, and thrive in fast-paced environments.

  • Strong problem-solving skills, including root cause failure analysis methods.

Travel Requirements:10%: Up to 26 business days per year

Benefits

West Pharmaceuticals Services Inc. offers an inclusive community of professionals with opportunities for lifelong learning, growth, and development. We empower our team members' physical, mental, emotional, and financial health and that of their families.

We believe in giving back to help those in need in the communities where we live and work. Our sustainability efforts aim to create a healthier environment and planet.

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