Product Quality Assurance Analyst III at Abbott

Alameda, California, United States

Abbott Logo
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

Key technologies and capabilities for this role

Quality AssuranceNonconformance ManagementComplaint InvestigationManufacturing DeviationsTrend AnalysisRisk EvaluationProduct ContainmentSoftware Defect Review

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 main responsibilities of this role?

The role involves reviewing escalated customer complaints, nonconformance reports, and deviations to identify issues and Risk Evaluations, facilitating cross-functional meetings, managing product containment activities like stop shipments and quality holds, and initiating Risk Evaluation processes.

What is the company culture like at Abbott?

Abbott emphasizes doing work that matters, personal growth and learning, caring for yourself and family, being your true self, career development in an international company, and is recognized as a great place to work, one of the most admired companies, and best for diversity, working mothers, female executives, and scientists.

What makes a strong candidate for this Product Quality Assurance Analyst III role?

Strong candidates will have experience in quality assurance within healthcare or manufacturing, particularly with product nonconformances, complaint investigations, risk evaluations, and cross-functional facilitation in a regulated environment like medical devices.

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