Compliance Engineer - 12 month fixed term contract at Abbott

Tory Island, County Donegal, Ireland

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, Diagnostics, ManufacturingIndustries

Requirements

Educated Third level qualification in Engineering / Manufacturing / Science disciplines
2 years experience in a similar environment preferred
Excellent communication / interpersonal skills
Enthusiastic and energetic with the ability to integrate quickly into a fast pace team environment

Responsibilities

Complete the Impact assessment and investigation of non-conformances associated with non-conforming products, out of Specifications (OOS), audit findings and customer complaints (CAPA)
Member of cross functional investigation team to ensure OOS investigations are completed in accordance with procedural requirements
Support Ops Manufacturing, ensure compliance across all areas (Audit Readiness)
Contributing to the creation and update where relevant of Work Instructions and Operation procedures to maintain compliance
Manage the Equipment Assets on site, maintain and update the Asset Management / Maintenance System
Supporting the engineering team in ensuring that facilities, utilities and equipment are maintained to meet the required standards
Maintain and manage the change control of updating the Asset management / Maintenance system
Develop Continuous Improvement Plans and activities as related to manufacturing and quality process
Coordinate and implement process and equipment projects. Identification of opportunities for new technology and driving continuous improvement
Manage and review the Operation KPI’s, (e.g. NC Closure Rate, Track & Trend, PM’s completed)
Review Change Control Documents and support the approval process of updated documents
Ensure adherence to 6 S in the Operation areas ensuring the department conducts its business in a manner designed to be protective of human health, safety and the environment
Maintain strong communication and working relationships with all departments
Responsible for compliance with applicable Corporate and Divisional Policies and performing other duties as assigned by management
Complete Tasks as assigned by Lead

Skills

Key technologies and capabilities for this role

CAPAOOS InvestigationsNon-conformance InvestigationAudit ReadinessAsset ManagementEquipment MaintenanceWork InstructionsSOPsCompliance Procedures

Questions & Answers

Common questions about this position

What is the employment type and duration for this Compliance Engineer role?

This is a full-time position on a 12 month fixed term contract.

Where is this Compliance Engineer position located?

The role is based at Abbott Diabetes Care division in Donegal Town, Ireland.

What are the main responsibilities of the Compliance Engineer?

Key responsibilities include completing CAPA impact assessments and investigations for non-conformances, supporting OOS investigations, ensuring audit readiness, managing equipment assets, and driving continuous improvement plans.

What education is required for this position?

Candidates must be educated to a third level.

What skills or experiences make a strong candidate for this role?

Strong candidates will have experience in CAPA investigations, OOS handling, audit support, asset management, change control, and continuous improvement in a manufacturing or quality environment, along with third level education.

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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