CAPA Engineer at Abbott

Kilkenny, County Kilkenny, Ireland

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, ManufacturingIndustries

Requirements

Minimum Level 7 NFQ qualification or equivalent in a relevant discipline
Minimum of 4 years experience in Engineering/Manufacturing/Scientific environment
Previous CAPA and/or quality assurance/engineering experience
Ability to demonstrate 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

Responsibilities

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, gather 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, and 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
Facilitate and execute the CAPA process
Support continuous improvement and effective maintenance of the QMS
Ensure the use of appropriate risk management tools to prioritise activities

Skills

Key technologies and capabilities for this role

CAPASix SigmaRoot Cause AnalysisQMSRisk ManagementProblem Solving

Questions & Answers

Common questions about this position

What qualifications and experience are required for the CAPA Engineer role?

A minimum Level 7 NFQ qualification or equivalent in a relevant discipline is required, along with at least 4 years of experience in an Engineering/Manufacturing/Scientific environment, previous CAPA and/or quality assurance/engineering experience, and demonstrated use of quality tools/methodologies. Prior medical device experience is preferred.

What are the key responsibilities of the CAPA Engineer?

Key responsibilities include participating in CAPA projects, collaborating with cross-functional teams using methodologies like Six Sigma, investigating issues, processing requests, identifying trends, ensuring on-time completion of deliverables, supporting CAPA training, and providing expertise during audits.

Is the CAPA Engineer position remote or on-site?

This information is not specified in the job description.

What is the salary or compensation for the CAPA Engineer role?

This information is not specified in the job description.

What makes a strong candidate for the CAPA Engineer position at Abbott?

Strong candidates will have prior medical device experience, demonstrated proficiency in quality tools and methodologies like Six Sigma, and the ability to collaborate with cross-functional teams while supporting QMS maintenance and audits.

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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