CAPA Engineer – Abbott
Abbott is a global healthcare leader. In Ireland, Abbott employs around 6,000 people across ten sites. The facility in Kilkenny will be a centre for world-class engineering, quality, medical device manufacturing, and other science-based professionals to produce life-changing technologies that enable people with diabetes to live the best and fullest lives they can. As a CAPA Engineer you will facilitate and execute the CAPA process, support continuous improvement and effective maintenance of the QMS, and use appropriate risk management tools to prioritise activities.
Key Responsibilities
* Participate in the completion of CAPA projects, ensuring compliance and quality of records.
* Collaborate with cross-functional teams using methodologies such as Six Sigma root cause analysis and problem solving.
* Independently investigate, gather data, and perform preliminary analysis.
* Process CAPA requests, ensuring owners are assigned and timely responses and approvals are provided in alignment with quality goals.
* Identify trends and potential issues, and drive improvement initiatives.
* Ensure on-time completion of Quality Assurance engineering deliverables.
* Support the CAPA training program and its delivery and oversight.
* Identify projects to enhance and promote the effectiveness and efficiency of the quality system and product quality.
* Support Operations to make Quality/Compliance decisions during processing, manufacturing, testing, monitoring and packaging.
* Provide support and subject matter expertise during audits and inspections.
Qualification And Experience
* Minimum Level 7 NFQ qualification or equivalent in a relevant discipline.
* Minimum of 4 years experience in an Engineering/Manufacturing/Scientific environment.
* Previous CAPA and/or quality assurance/engineering experience.
* Ability to demonstrate use of quality tools and 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 leading multi-departmental project teams and resolving quality-related issues in a timely and effective manner.
* Advanced computer skills, including statistical/data analysis and report writing.
What We Offer
* Attractive compensation package with competitive pay
* Family health insurance
* Excellent pension scheme
* Life assurance
* Career development opportunities
* Modern facility and resources
* Growing business with access to additional benefits
Abbott is an equal opportunities employer.
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