CAPA Engineer

at  Abbott Laboratories

At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader, and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.

QUALIFICATION AND EXPERIENCE

• Minimum Level 7 NFQ qualification or equivalent in a relevant discipline.
• Min of 4 years experience in Engineering/Manufacturing/Scientific environment.
• Previous CAPA and/or quality assurance/engineering experience.
• Ability to 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.
• Good communication and interpersonal skills.
• Previous 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

• Participate in the completion of CAPA projects, ensuring compliance, and quality 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.
• Identify trends potential issues, improvement initiatives.
• Ensure on-time completion of Quality Assurance engineering deliverables.
• Support team in the delivery and oversight of CAPA training program.
• Identify projects to enhance and promote 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.
• Provide support and subject matter expertise during audits and inspections.