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West Pharma Senior Quality Engineer Design Ireland, Waterford 446507768
24.08.2025
Essential Duties and Responsibilities
- Program Activities:
- Responsible for ensuring proprietary design & development projects are executed in compliance with relevant regulations; regulatory requirements; international standards; and enterprise and local procedures.
- Identify and support the use of improved quality practices by R&D teams during design control activities; and facilitate the smooth integration of quality requirements into design processes.
- Report on the progress of projects; 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; labelling; procedures.
- Support design transfer activities for commercial and launch readiness and sustainment.
- Verification and Validation Activities:
- Review and approve test method validations (protocols and reports).
- Review and approve design verification and design / process validation documents (e.g. protocols & technical reports).
- Facilitate and support the completion of projects up to and including PQ.
- Risk Management Activities:
- Responsible for authoring and/or reviewing and approving Risk Management Plans, risk assessments and Risk Management Summary Reports for proprietary design & development projects.
- Facilitate and/or participate in risk assessment meetings with proprietary design & development teams.
- QMS Activities:
- Support enterprise procedures updates that impact design and development activities.
- Drive the closure of change controls and protocol non-conformance reports (PNRs).
- Review and draft relevant procedures and forms for the management of activities connected with product design & development.
- Act as the interface between development teams and operational quality:
- Perform first article component and product inspections
- Draft defect libraries and quality inspection 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 and support internal and supplier audits, as required.
- Lead internal audits of R&D and support site QA in the preparation and hosting of third party and customer audits.
- Lead and manage QMS activities including CAPAs, Failure Investigations, Non-Conformance assessments, audit findings, issue reviews, document control, change controls, and configuration management. Provide direction on non-conformances, deviations, or excursions and drive to closure.
- Actively engage in robust problem-solving to address quality issues.
- Metrology Activities:
- Review and approve metrology data during OQ & PQ.
- Support Quality Function Deployment activities (QFD).
- 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.
- Perform additional duties at the request of the direct supervisor.
- Bachelor'sDegree in Chemistry, Engineering or Quality disciplinerequired
Work Experience
5 years working in a high-volume manufacturing environment, ideally in the Medical Device / Pharmaceutical sectors.
Desirable: Regulatory Affairs experience
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 ISO 13485, ISO 9001, ISO 15378 and 21 CFR Part 820 is essential
- Work experience in the life science industry or another highly regulated, international environment would be considered an advantage
- Experience in Project Management
- Experience in process technology, by preference with elastomers.
- Risk Management experience within design and development 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).
- Must be able to organise and prioritise tasks.
- Must have critical reading skills, maintain a high attention to detail and overall quality of work.
- Must be self-motivated, able to prioritize and multi-task, work independently and make sound judgements, work under time constraints, thrive in face-paced environments.
- Strong problem-solving skills, including root cause failure analysis methods.
- Must have excellent written and verbal communication skills.
License and Certifications
- ISO 13485/9001/15378 Auditor or Lead Auditor Training / Certification upon hire is preferred.
Additional Requirements
- Exhibit a strong “quality first” mentality and ensure that product and process quality are held to the highest standard.
- Excellent written and oral communication and interpersonal abilities, with the capacity to communicate complex technical concepts to diverse stakeholders.
- Ability to work independently, multi-task and thrive in fast-paced environment.
- Strong problem-solving skills including root cause failure analysis methods.
- Adaptable to changes in the work environment, manage competing demands and deal with frequent change, delays or unexpected events.
- Must maintain the ability to work well with others in a variety of situations.
- Critical reading skills and maintain high attention to detail, accuracy, and overall quality of work.
- Must be able to multi-task, work under time constraints, problem solve, and prioritize.
- Ability to make independent and sound judgments.
- Observe and interpret situations, analyze and solve problems.
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