Quality Systems Analyst II at Abbott

Alameda, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, DiagnosticsIndustries

Requirements

Bachelor’s degree required
Minimum 3 years of experience in a manufacturing environment; medical device industry experience preferred
Experience conducting complaint investigations in a regulated environment
Knowledge of FDA Quality System Regulations (QSR) and ISO 13485 standards

Responsibilities

Support trend escalations, ensuring potential product or process issues are thoroughly assessed and effectively managed, including applying structured root cause analysis (RCA) methodologies such as 5 Whys, Fishbone diagrams, and 6M frameworks to identify underlying drivers, validate findings, and reach well-supported conclusions for investigations
Support complaint investigation activities related to glucose meters, ensuring compliance with procedures and timely completion
Partner with cross-functional Quality and Business Unit teams to deliver required reporting, including complaints trending and summaries, FDA Medical Device Reporting (MDR) trending and summaries, EU Medical Device Vigilance trending and summaries, and weekly, monthly, and quarterly product line complaint reports
Prepare and provide relevant reports and analysis in support of internal and external audits
Support company initiatives aligned with the Quality Management System (QMS), Environmental Management System (EMS), and other regulatory requirements
Ensure compliance with FDA regulations, international regulatory requirements, and corporate/divisional policies, procedures, and processes
Perform additional related duties and responsibilities as assigned

Skills

Key technologies and capabilities for this role

Root Cause Analysis5 WhysFishbone Diagrams6M FrameworksTrend EscalationsComplaint InvestigationsQuality Systems

Questions & Answers

Common questions about this position

What benefits does Abbott offer?

Abbott provides free medical coverage in the Health Investment Plan (HIP) PPO medical plan, an excellent retirement savings plan with high employer contribution, tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit for earning a bachelor’s degree.

Is this position remote or onsite?

This position is based out of Abbott Diabetes Care in Alameda, CA, and requires the individual to be onsite Monday-Friday.

What are the required qualifications for the Quality Systems Analyst II role?

A Bachelor’s degree is required along with a minimum of 3 years of experience in a manufacturing environment, specifically medical.

What skills will I use in this role?

You will apply structured root cause analysis methodologies such as 5 Whys, Fishbone diagrams, and 6M frameworks, support complaint investigations for glucose meters, prepare trending reports and summaries for FDA MDR, EU Vigilance, and audits, and ensure compliance with FDA regulations and QMS.

What is the salary for this position?

This information is not specified in the job description.

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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