Supplier Quality Engineer at Abbott

Temecula, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Associates Degree
Minimum 1 year related experience in technical or other QA related positions in a regulated industry (preferred)
ISO lead auditor certification or equivalent (preferred)
5 years experience (preferred)
Demonstrated writing and communication skills
Thorough understanding of ISO/QSRs and ability to apply that knowledge with understanding of business operations to achieve regulatory compliance
Ability to explain audit results and influence others' understandings of audit observations in a tactful and professional manner
Knowledge of regulations and standards affecting in vitro diagnostic device manufacturing
Ability to handle supplier audit situations and interactions in a tactful, professional, and effective manner

Responsibilities

Develop and execute to a supplier audit schedule per current requirements
Develop audit plans and associated supplier communications
Approve and monitor Supplier CAPA plans and activities to closure including objective evidence of effectiveness
Per current requirements, perform activities that will qualify new suppliers and monitor current supplier base to ensure the status of the suppliers is correct
Work with suppliers as needed to ensure their performance is acceptable per site requirements
Work with Design and Development, Manufacturing, Purchasing, and IQA when qualifying and monitoring supplier performance
Through supplier audits and internal issues with supplier product, issue SCARs for supplier corrective/preventive action activities
Analyze supplier information and present supplier metrics to appropriate CAPA boards

Skills

Supplier Audits

Quality Engineering

Supplier Quality

Medical Devices

Vascular Products

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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