Overview

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 107,000 colleagues serve people in more than 160 countries

Abbott Rapid Diagnostics is part of Abbottu2019s 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 Senior Quality Engineer u2013 Toxicology Testing position is responsible for oversight of technical quality assurance primarily focused on ensuring that all aspects including facility, equipment test methods, processes and software and subsequent changes to them, are validated in compliance with applicable regulations, standards and Abbott policies and procedures. This role works closely with all departments especially toxicology laboratory operations and IT teams to develop and maintain the siteu2019s validation status and helps build a fit for purpose Quality Management System (QMS) that supports the business.

This position will play an important role in coordination of validation projects including QMS optimization. The Senior Quality Engineer will work with the site on non-conformance and Corrective Action and Preventative Action (CAPA) investigations and is expected to perform their duties with a high degree of independence, reporting to quality and site leadership on status of the validation program and risks.u00A0

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

RESPONSIBILITIES:

– Oversee and manage laboratory validation master plan and maintaining the facility in a validated state
– Collaborate with peers to draft, review and approve validation protocols and reports
– Provide guidance/training on the use of appropriate statistical techniques and sampling plans with respect to the laboratory and other validations, nonconformance and CAPA programs and other testing protocols
– Lead teams in root cause analysis of laboratory quality issues in alignment with Abbottu2019s best practices. Apply appropriate tools (e.g. statistics, fault tree analysis, etc.) and work with peers to develop corrective action plans.
– Assist in process data collection and analysis to monitor performance of key laboratory processes
– Develop and report on quality metrics, as they relate to validation activities and compliance, to present at quarterly management review meetings
– Support the Non-Conformance and CAPA processes by performing investigations and root cause analysis, determining action plans and driving the actions to verify effective closure
– Support internal and external audits/inspections as necessary
– Prioritizes activities and takes prompt action based on an understanding of quality objectives and business needs
– 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

MINIMUM QUALIFICATIONS | EDUCATION/EXPERIENCE:

– Bacheloru2019s Degree in Engineering, Chemistry, Bio-Technology, Life Science or a related discipline, or the equivalent combination of education and experience
– 3 or more years of experience in regulated environment such as laboratory or medical device
– Previous experience contributing to or managing validation projects from the point of inception to completion, including those that require multiple skills
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PREFERRED QUALIFICATIONS:

– Experience preferred with root cause analysis and/or failure mode analysis
– Advanced proficiency with Microsoft Suite (Outlook, Word, Excel, Power Point) and Microsoft Project
– Experience with statistical tools including basic statistical inference, graphical methods, regression, Design Of Experiment (DOE), development of sampling plans
– Project coordinator or comparable experience in the healthcare or laboratory industry
– Six Sigma and/or ASQ certification
– Supports business needs across different time-zones globally and during periods of heavy workload
– Able to learn new tools and systems in an ever-evolving fast-paced environment
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COMPETENCIES:

– Self-starter with ability to work collaboratively
– Multi-tasking skills with competing priorities
– Able to meet deadlines
– Teamwork
– Communication skills u2013 verbal and written
– Achieving results
– Strong organization and follow-up skill
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About Abbott:

At Abbott, we’re committed to helping people live their best possible life through the power of health. For more than 130 years, we’ve brought new products and technologies to the world — in nutrition, diagnostics, medical devices and branded generic pharmaceuticals — that create more possibilities for more people at all stages of life. Today, 107,000 of us are working to help people live not just longer, but better, in the more than 160 countries we serve.
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An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities. To request an accommodation, please send an email to .

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