Quality Validation Engineer at Abbott

Kilkenny, County Kilkenny, Ireland

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, Diabetes CareIndustries

Requirements

Relevant third level qualification (Engineering/Manufacturing/Science preferred)
Minimum 2 years in the Engineering/Manufacturing/Scientific field
2-3 years working knowledge of process, equipment, facilities and/or software validation within Quality or Engineering departments
Experience working in a 21CFR820 and/or ISO13485 regulated industry (may consider pharmaceutical validations)
Basic understanding of design controls and design transfer

Responsibilities

Creating and implementing the Abbott Division validation program
Creating and maintaining validation documentation for new and existing systems and processes subject to design control
Ensuring validation activities are implemented for systems and processes used to manufacture, control and store intermediates and finished products to requirements and standards in the Quality Systems Manual
Development and maintenance of Quality System procedures
Ensuring the site delivers safe and effective products that meet customer needs whilst maintaining compliance
Monitoring and maintaining the quality and compliance status of associated quality records
Maintaining the quality and compliance status of associated Procedures, work instructions and training materials
Presenting and communicating status, reporting metrics, identifying trends, potential issues, and improvement initiatives
Review and approval of validation documentation in accordance with divisional policies

Skills

Key technologies and capabilities for this role

ValidationQuality SystemsDesign ControlQuality DocumentationComplianceProcess ValidationManufacturing ProcessesQuality Procedures

Questions & Answers

Common questions about this position

What compensation is offered for this Quality Validation Engineer role?

Abbott offers an attractive compensation package that includes competitive pay, as well as benefits.

Is this Quality Validation Engineer position remote or on-site?

This information is not specified in the job description.

What qualifications and experience are required for this role?

A relevant third level qualification in Engineering/Manufacturing/Science is preferred, with a minimum of 2 years in the Engineering/Manufacturing/Scientific field and 2-3 years of working knowledge in process, equipment, facilities, and/or software validation. Experience in a 21CFR820 and/or ISO13485 regulated industry is required.

What is the work environment like at Abbott Diabetes Care in Kilkenny?

The role is at Abbott Diabetes Care's new site in Kilkenny, at the forefront of diabetes care with the latest technology, manufacturing FreeStyle blood glucose test strips and sensors, focused on delivering safe and effective products that meet customer needs while maintaining compliance.

What makes a strong candidate for this Quality Validation Engineer position?

Candidates with experience developing projects or sites from square one will have a very big plus, along with a strong background in validation within regulated industries.

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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