Operations Quality Shift Lead 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, Diagnostics, ManufacturingIndustries

Requirements

A minimum of a NFQ Level 7 Qualification in Science / Engineering or Manufacturing qualification
Minimum of 4 years’ experience in Manufacturing
Minimum 2 years’ experience in people management
Yellow belt qualified desired
Strong communication and organisation skills
Strong problem solving
Experience with GMP/GDP
ISO13485 experience

Responsibilities

Oversees operational implementation of quality assurance strategies and regulations
Completes the assessment of potential risks, ensures compliance, and gives recommendations to management
Supervises team to ensure quality control aspects of the process are met (laboratories studies, clinical research, testing, operations, raw materials, production, finished product or services)
Facilitates audits and regulatory inspections
Liaises with external vendors, contractors, or suppliers to ensure that their products or services meet the organisation's quality standards
Lead a team of Operations Quality engineers
Manage functional area’s compliance to site and divisional policies and procedures
Lead the continuous improvement and effective maintenance of the QMS
Subject Matter Expert in use of risk management tools to prioritise activities and justify the effort required
Accountable for building and maintaining successful cross functional relationships with departments such as R&D, Technical, Engineering, Operations and Regulatory Affairs in order to achieve all project goals
Manage teams Health and Safety within the working environment; highlight opportunities for improvement to EHS performance
Act as Lead for the monitoring and compliance of the Quality Management System as it applies to site Operations
Lead team in making Quality / Compliance decisions on product during processing, manufacturing, testing, monitoring, and packaging
Lead audit readiness in functional area
Identify and lead projects to enhance and promote the effectiveness and efficiency of the quality system and product quality
Champion a “right first time” approach to Quality Records by ensuring accountability for functional responsibilities

Skills

Key technologies and capabilities for this role

Quality AssuranceQuality ControlManufacturingInspectionTestingRisk AssessmentAuditsRegulatory ComplianceSupervisionDiabetes CareGMP

Questions & Answers

Common questions about this position

What are the main responsibilities of the Operations Quality Shift Lead?

The role involves overseeing operational implementation of quality assurance strategies, supervising teams for quality control, facilitating audits and inspections, leading continuous improvement of the QMS, and managing compliance and health & safety.

Is this a remote position or does it require on-site work?

This information is not specified in the job description.

What is the salary or compensation for this role?

This information is not specified in the job description.

What shift schedule does this position involve?

This is a shift role on 4 cycles.

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

Strong candidates will have expertise in risk management tools, experience leading quality/compliance decisions in manufacturing and testing, and the ability to build cross-functional relationships with departments like R&D, Engineering, and Regulatory Affairs.

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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