Senior Quality Engineer Leader - Medical Devices (Onsite)

Stryker; Ireland; On-site; EUR 62,000 - 105,000; Full time

Benefits offered by this job

Full benefits

Job summary

Stryker in Macroom, Ireland is seeking a Senior Staff Quality Engineer for a 23-month, fully onsite contract. The role drives quality leadership, preventive activities, CAPA and continuous improvement across operations and business functions.

You will mentor teams, manage audits, and ensure ISO13485, GDP and GMP compliance while collaborating with global QA and cross-functional partners. The position requires 6+ years in a regulated environment and a level 8 Bachelor’s degree, with a

Qualifications

• Honours Bachelor’s Degree – level 8.
• Masters or PhD advantageous.
• 6+ years’ experience in a regulated environment (e.g. Medical Device, Aviation, Aerospace, Automotive, Defence).
• Proficient understanding of Med Device manufacturing processes.
• Proficient in ISO 13485, GDP, and GMP with strong collaboration and attention to detail.

Responsibilities

• Provide quality leadership, direction and technical guidance in QA, QC and preventive activities.
• Lead initiatives to enhance quality performance and support internal customers on quality issues.
• Mentor teams and ensure compliance to regulations and standards.
• Collaborate with cross-functional teams to promote quality initiatives and manage supplier relationships.
• Lead CAPA problem solving, risk management and statistical analysis in production processes.
• Develop and maintain quality processes and validation strategies; oversee audits and reviews.
• Drive continuous improvement, KPI trend analysis and containment strategies on site.

Skills

Quality leadership

CAPA

Root cause analysis

Audit management

Risk management

Process improvement

Cross-functional collaboration

Education

Bachelor’s degree (level 8)

Masters/PhD advantageous

Tools

ISO 13485

GMP

Job description

Stryker in Macroom, Ireland is seeking a Senior Staff Quality Engineer for a 23-month, fully onsite contract. The role drives quality leadership, preventive activities, CAPA and continuous improvement across operations and business functions.

You will mentor teams, manage audits, and ensure ISO13485, GDP and GMP compliance while collaborating with global QA and cross-functional partners. The position requires 6+ years in a regulated environment and a level 8 Bachelor’s degree, with a