Senior Quality Engineer – Med Device (Onsite)

Stryker Corporation; Hartnett's Cross; On-site; EUR 62,000 - 105,000; Full time

Benefits offered by this job

Full benefits

Job summary

Stryker Corporation in Macroom, Ireland, is seeking a Senior Staff Quality Engineer to lead quality assurance, control and preventive activities within operations. You will drive continuous improvement, mentor teams, and ensure compliance with ISO 13485 and GMP.

This onsite role requires strong collaboration, risk management, and the ability to address production-related issues and CAPA across multiple functions. 6+ years in a regulated environment are expected.

Qualifications

• Honours Bachelor’s Degree (level 8); Master’s/PhD advantageous.
• 6+ years’ experience in a regulated environment (e.g., Medical Device).
• Proficient understanding of Medical Device manufacturing processes.
• Proficient in ISO 13485, GDP, and GMP.
• Strong collaboration and communication skills across levels.

Responsibilities

• Provide quality leadership and guidance in QA/QC and preventive activities.
• Lead initiatives to enhance quality performance and CAPA within the business.
• Support internal customers on quality issues and audits and provide technical support for quality system assessments.
• Mentor quality teams and manage supplier relationships and internal/external nonconformities.
• Apply risk management, statistical analysis and process control methods in production.

Skills

Regulated environment experience

Medical device manufacturing

ISO 13485/GDP/GMP

Communication skills

Cross-functional collaboration

Education

Bachelor’s degree

Master’s or PhD advantageous

Job description

Stryker Corporation in Macroom, Ireland, is seeking a Senior Staff Quality Engineer to lead quality assurance, control and preventive activities within operations. You will drive continuous improvement, mentor teams, and ensure compliance with ISO 13485 and GMP.

This onsite role requires strong collaboration, risk management, and the ability to address production-related issues and CAPA across multiple functions. 6+ years in a regulated environment are expected.