Product Quality Assurance 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

Bachelors Degree with a minimum of 6 yrs of relevant work experience (Risk Management, Technical Writing and/or Post Market Surveillance activities) or equivalent education and work experience
Minimum 3 yrs at a Senior Specialist level required
Prior experience in the medical device industry and or quality systems are required
Strong working knowledge of FDA

Responsibilities

Reviewing customer complaints, exception reports, technical investigations, manufacturing deviations and regulatory requirements against existing historical analysis to identify new issues
Facilitate cross functional meetings to make recommendations on the need for product controls and or risk evaluations
Initiating and facilitating product control processes and documentation
Drafting, reviewing, and issuing stop shipments, quality holds, and dispositions in alignment with the exception report processes as applicable
Initiating and facilitating the risk evaluation processes
Drafting, reviewing, and closing risk evaluations with inputs from cross functional teams
Preparing and participating or facilitating in regular meetings with Senior Level management
Coordinating slides, meeting minutes, and action items
Participate in design reviews as required providing technical inputs and historical information for product controls
Draft, review and implement process improvements through procedures and work instructions
Collate and interpret team metrics
Compile, manipulate, and draft presentable team data for Post-Market Surveillance reviews
May support the coordination and execution field actions as they arise, including assisting with progressing associated documentation
Collate Quality Hold data for product accountability
Provides direction to junior staff on daily activities
Provides recommendations for product control and risk evaluations
Escalate issues to Management and serve as delegate for management as appropriate in audit settings
Communicate directly to Customer Service, Sales and Marketing, and other affected areas of the business for new issues as well as product releases
Responsible for adhering to quality policies
Maintaining original files in PQA archival system

Skills

Key technologies and capabilities for this role

Quality AssuranceComplaint InvestigationsManufacturing DeviationsTrend AnalysisRegulatory RequirementsTechnical InvestigationsException ReportsNon-conformities

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 a remote position or does it require office work?

This information is not specified in the job description.

What are the main responsibilities of the Product Quality Assurance Analyst II?

The role involves reviewing customer complaints and manufacturing deviations, facilitating cross-functional meetings for product controls and risk evaluations, drafting stop shipments and quality holds, preparing management meeting materials, and collating team metrics for post-market surveillance.

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 role?

Strong candidates should have experience facilitating cross-functional teams, analyzing complaints and deviations, managing risk evaluations and product controls, and communicating effectively with senior management through meetings and metrics.

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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