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Laboratory Quality Specialist (FTC) at Abbott Toxicology Ltd

Laboratory Quality Specialist (FTC)

Abbott Toxicology Ltd Loughton, Essex, Essex Full-Time
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Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

The position of Laboratory Quality Assurance Specialist is within our Toxicology Business Unit located at Loughton, UK.

This position is responsible for delivering Quality Management System changes to ensure the business is ready for the new IVD and Medical Device Regulations. This candidate will be coordinating with cross-functional teams, including but not limited to , BU, Division and Corporate AQR, Marketing, Operations, R&D and Supply Chain to ensure that all deliverables are completed correctly and delivered on time.

This job description will be reviewed periodically and is subject to change by management.

RESPONSIBILITIES:

• Develop necessary project plans and manage reporting on project progress and achievement of key milestones.

• Oversee project to make necessary updates to Quality System requirements across all functional areas to align to new requirements in the new regulations.

• Draft policies and SOPs tailored to ATOX business as necessary and drive to make live in the system.

• Develop training plans and participate in training activities.

• Support the QARA team in routine activities.

• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

• Perform other duties & projects as assigned.

BASIC QUALIFICATIONS | EDUCATION:

Bachelor’s Degree in related field

Experience in Quality Assurance or Regulatory Affairs within the IVD or medical device industry

Experience leading projects to completion.

Demonstrate ability to effectively and constructively communicate across departmental disciplines while pursuing project goals

Proven ability to provide sound conclusions and recommendations

Understanding of new IVDR and MDR requirements

Understanding of ISO 13485

Experience in writing Standard Operating Procedures and upgrading Quality Systems.

Designing & Delivering training effectively

PREFERRED QUALIFICATIONS:

Experience of Techncial Files and Post Market Surveillance.

Strong understanding of ISO13485 and IVDR / MDR requirements

Experience in writing Standard Operating Procedures and upgrading Quality Systems.

COMPETENCIES:

Strong communication and leadership skills

Able to drive actions to completion across multiple teams.

Demonstrate organizational skills with a focus on detailed work

Ability to initiate and manage multiple tasks in a fast-paced environment

Must be able to work as part of a team, meet deadlines & take instruction from multiple persons

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce
 

Recommended skills

Quality Management Systems
Iso 13485
Iso 13485 Standard
Quality Assurance
Operations
Leadership
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Job ID: 212499253