Staff Quality Engineer: CAPA & Process Improvement

Stryker; Cork; Hybrid; EUR 54.000 - 90.000; Vollzeit

Benefits dieser Stelle

Comprehensive benefits

Bonus incentive eligibility

Zusammenfassung

Stryker is seeking a Staff Quality Engineer to lead quality assurance, quality control and preventive activities onsite in Carrigtwohill, Ireland. You will champion quality systems, support regulatory compliance, and drive continuous improvement across product and process quality.

The role requires strong leadership, problem solving, and cross-functional collaboration to resolve quality issues with Operations and suppliers. Travel to multi-site locations may be involved as part of this role.

Qualifikationen

• Honours Bachelor’s Degree in Science/Engineering or related
• 4+ years’ experience in a Quality or Regulatory Affairs role; prior industry experiences desirable
• Proficient in understanding of Med Device manufacturing processes, ISO 13485, GMP
• Lean Six Sigma training is a distinct advantage
• Outstanding communication and attention to detail; able to communicate across levels
• Knowledge of Risk Based and statistical techniques (CAPA, Audits, Statistics)

Aufgaben

• Lead quality leadership and preventive activities across operations and business functions
• Drive continuous improvement of products and processes
• Coach and provide technical direction across multiple areas of expertise
• Manage internal and supplier-driven Non-Conformances (NCs) and CAPAs
• Dispostion of non-conforming product through MRB and NC issuance
• Lead and participate in internal/external audits with regulatory reps
• Input into concession/change management and risk assessment processes
• Develop validation strategies and support manufacturing transfers
• Monitor KPI trends and drive corrective action and improvement
• Travel as required to support multi-site activities

Kenntnisse

Strong communication

Leadership & mentoring

Problem solving

Cross-functional collaboration

Risk management

Ausbildung

Bachelor’s Degree in Science/Engineering

4+ years in Quality or Regulatory Affairs

ISO 13485, GMP knowledge

Lean Six Sigma training

Regulatory audits experience (FDA/MoH/TUV)

MS Office proficiency

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Jobbeschreibung

Stryker is seeking a Staff Quality Engineer to lead quality assurance, quality control and preventive activities onsite in Carrigtwohill, Ireland. You will champion quality systems, support regulatory compliance, and drive continuous improvement across product and process quality.

The role requires strong leadership, problem solving, and cross-functional collaboration to resolve quality issues with Operations and suppliers. Travel to multi-site locations may be involved as part of this role.