Abbott

CAPA Engineer

Ireland - Kilkenny Full time

JOB DESCRIPTION:

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

Abbott in Ireland

Abbott has been operating in Ireland since 1946 and serves the Irish market with a diverse range of healthcare products including diagnostics, diabetes care, medical devices and nutritional products. In Ireland, Abbott currently employs about 6,000 people across ten sites located in Dublin, Donegal, Clonmel, Cootehill, Galway, Kilkenny, Longford and Sligo.

Abbott Diabetes Care Kilkenny

Abbott Diabetes Care has opened  a new site, in Kilkenny, that is  at the forefront of Diabetes care with the latest technology, to manufacture FreeStyle blood glucose test strips and FreeStyle Sensors for use in diabetes management. Among Abbott Diabetes Care leading brands are the FreeStyle Precision, FreeStyle Lite and FreeStyle Libre systems.

This is how you can make a difference at Abbott:

As a CAPA Engineer you will facilitate and execute the CAPA process. You will also support continuous improvement and effective maintenance of the QMS. Ensure the use of 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 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.

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

What we Offer

Attractive compensation package that includes competitive pay, as well as benefits such as

  • Family health insurance,

  • Excellent pension scheme

  • Life assurance

  • Career Development

  • Fantastic new facility

  • Growing business plus access to many more benefits.

Connect with us at www.abbott.com or https://www.ie.abbott/, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.

Abbott is an equal opportunities employer.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Operations Quality

DIVISION:

ADC Diabetes Care

LOCATION:

Ireland > Kilkenny : Kilkenny Business and Technology Park

ADDITIONAL LOCATIONS:

WORK SHIFT:

Ie - Kkyflx (Ireland)

TRAVEL:

Not specified

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Not Applicable