Senior Quality Engineer, NPI & Validation

West Pharmaceutical Services; Dublin; On-site; EUR 65,200 - 82,992; Full time

Job summary

West Pharmaceutical Services seeks an experienced NPI Quality Engineer to support projects with emphasis on QSRs, cGMPs, ISO 13485 and customer specifications. You will coordinate activities to ensure timely closure of internal and external quality issues, driving a culture of compliance and continuous improvement across NPI programs.

You will partner with the NPI Senior Quality Manager and Program Manager, providing technical and quality resources to manage quality milestones, risk assessments,

Qualifications

• Must have a third-level qualification in Engineering/Quality/Science.
• Minimum of 5 years’ experience in a high-volume manufacturing environment, preferably medical device/pharma.
• Thorough understanding of statistics, SPC, and ideally Minitab.
• Excellent communication skills, both oral and written.
• Ability to prioritize and organize tasks.

Responsibilities

• Coordinate validation activities and ensure timely closure of quality issues.
• Lead risk management planning including RMP, FMEA and risk registers.
• Develop VMP, review validation documentation and maintain document trackers.
• Support QMS activities and audits.
• Manage customer documents and training related to quality systems.

Skills

Communication skills

Prioritization

Quality focus

Problem solving

Education

Engineering/Quality/Science degree

Job description

West Pharmaceutical Services seeks an experienced NPI Quality Engineer to support projects with emphasis on QSRs, cGMPs, ISO 13485 and customer specifications. You will coordinate activities to ensure timely closure of internal and external quality issues, driving a culture of compliance and continuous improvement across NPI programs.

You will partner with the NPI Senior Quality Manager and Program Manager, providing technical and quality resources to manage quality milestones, risk assessments,