Product Quality Assurance Analyst III at Abbott

Alameda, California, United States

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Based in Alameda, CA and expected to be onsite Monday-Friday
Ability to review escalated customer complaints, exception/nonconformance reports, manufacturing deviations, and regulatory requirements against historical analysis
Facilitate cross-functional meetings and make recommendations on product control and Risk Evaluations
Draft, review, and issue stop shipments, quality holds, digital product containment activities, and product dispositions
Assist in completing product accountability for Quality Holds
Initiate and facilitate Risk Evaluation processes, including cross-functional team recommendations
Draft, review, and manage approval of Risk Evaluations with cross-functional input
Prepare and participate/facilitate Risk Evaluation Executive Management Review meetings with Senior Level management
Escalate grey market, diverted, counterfeit, or stolen product issues to Global Product Protection
Draft, review, and implement process improvements through procedures and work instructions
Assist with drafting and execution of field actions, Advisory Notices, and associated documents
Provide direction to junior staff on daily activities
Escalate issues to Management and serve as delegate for management as appropriate
Collate Risk Evaluation, Product Containment, and complaint data, and draft summary slides for Post-Market Surveillance reviews
Support audit activities including compiling lists, pulling/reviewing PQA documents, and working on audit responses
Review investigation reports related to new, previously unidentified product defects/deficiencies

Responsibilities

Assist in identifying, reviewing, and facilitating assessments of the impact of worldwide product nonconformances on ADC products from complaint investigations, manufacturing deviations, trend analysis, or software defect reviews
Manage completion of product containment activities and Risk Evaluations, and associated activities addressing nonconformances
Escalate higher risk nonconformances to executive management
Manage the completion of product containment activities and Risk Evaluations for product nonconformances

Skills

Quality Assurance

Nonconformance Management

Complaint Investigation

Manufacturing Deviations

Trend Analysis

Risk Evaluation

Product Containment

Software Defect Review

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.

Land your dream remote job 3x faster with AI

Try Jobo Free