Senior Quality Assurance Engineer – Process & CAPA Leader

Stryker; Carrigtwohill; Vor Ort; EUR 54.000 - 90.000; Vollzeit

Benefits dieser Stelle

Comprehensive benefits package

Travel opportunities (10% travel)

Zusammenfassung

Stryker Ireland seeks a Staff Quality Engineer to lead quality assurance and control activities, driving preventive actions and continuous improvement within operations. You will coach teams, collaborate cross-functionally, and support regulatory compliance across multiple processes.

You will own CAPAs, assist in risk management, and participate in audits while maintaining high quality standards across site operations in Carrigtwohill, Ireland.

Qualifikationen

• Honours Bachelor’s Degree in Science/Engineering.
• 4+ years’ experience in quality or regulatory affairs.
• Proficient in Med Device manufacturing processes, ISO 13485, GMP.
• Lean Six Sigma training is a distinct advantage.
• Outstanding communication and attention to detail.

Aufgaben

• Provide quality leadership and direction in QA, QC and preventive activities.
• Collaborate cross-functionally to resolve quality issues.
• Manage non-conformances (NCs) and CAPAs through RCA to closure.
• Disposition non-conforming product via MRB and issue NCs as needed.
• Lead internal and external audits with regulatory representatives.

Kenntnisse

Quality leadership

CAPA

Risk management

Problem solving

Communication

Ausbildung

Honours Bachelor’s Degree - Science/Engineering

Lean Six Sigma training

Tools

MS Word

MS Excel

PowerPoint

Jobbeschreibung

Stryker Ireland seeks a Staff Quality Engineer to lead quality assurance and control activities, driving preventive actions and continuous improvement within operations. You will coach teams, collaborate cross-functionally, and support regulatory compliance across multiple processes.

You will own CAPAs, assist in risk management, and participate in audits while maintaining high quality standards across site operations in Carrigtwohill, Ireland.