CAPA Engineer – Quality & Continuous Improvement (Ireland)

Thornton Tomasetti; Kilkenny; On-site; EUR 60,000 - 85,000; Full time

Benefits offered by this job

Family health insurance

Pension scheme

Life assurance

Career development

New facility

Job summary

Abbott Kilkenny is seeking a Quality Assurance/Engineering professional to drive CAPA activities and maintain the QMS on site.

You will partner with cross-functional teams to ensure compliance, timely records, and lead improvement projects; support audits and training programs to sustain product quality.

The role emphasizes data analysis, problem solving, and collaboration across departments in a manufacturing setting in Ireland.

Qualifications

• Minimum Level 7 NFQ qualification or equivalent in a relevant discipline.
• Previous CAPA and/or quality assurance/engineering experience and demonstrated use of quality tools/methodologies.
• Prior medical device experience preferred.
• Knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485:2016.
• Solid communication and interpersonal skills.
• Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
• Advanced computer skills, including statistical/data analysis and report writing skills.

Responsibilities

• Participate in, or lead, the completion of CAPA projects, assuring compliance, quality and timeliness of records.
• Collaborate with cross-functional teams using various methodologies (e.g. Six Sigma root cause analysis/problem solving skills).
• Independently investigate, gathers data, and perform preliminary analysis.
• Process requests, ensuring owners are assigned, and timely responses and approvals are provided in alignment with quality goals.
• Present and communicate status, report metrics, identify trends potential issues, improvement initiatives, as applicable
• Execute and provide on-time completion of Quality Assurance engineering deliverables.
• Support team in the delivery and oversight of CAPA training program.
• Responsible for identifying projects to enhance and promote the effectiveness and efficiency of the quality system and product quality.
• Support Operations to make Quality / Compliance decisions on product during processing, manufacturing, testing, monitoring and packaging
• Ensuring the site delivers safe and effective products that meet customer needs whilst maintaining compliance
• Provide support and subject matter expertise during audits and inspections.

Skills

CAPA experience

Quality assurance

Project management

Communication skills

Data analysis

FDA/ISO knowledge

Education

NFQ Level 7 or equivalent

Bachelor's degree in a relevant discipline

Tools

Minitab

Excel

Job description

Abbott Kilkenny is seeking a Quality Assurance/Engineering professional to drive CAPA activities and maintain the QMS on site.

You will partner with cross-functional teams to ensure compliance, timely records, and lead improvement projects; support audits and training programs to sustain product quality.

The role emphasizes data analysis, problem solving, and collaboration across departments in a manufacturing setting in Ireland.