Quality Assurance Manager at Abbott

Alameda, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, DiagnosticsIndustries

Requirements

Bachelor’s degree or an equivalent combination of education and work experience
Minimum 7 years of experience in a FDA/ISO regulated environment
Minimum 5 years of experience in Quality
Substantial demonstrated initiative and problem-solving skills; critical-thinking skills (preferred)
Experience in leading & managing a large team of people (preferred)
Experience working in process and test method development in a Quality management system, in collaborations with Quality Assurance/ with Operations and R&D (preferred)

Responsibilities

Oversee complaint investigation lab output and proficiency by developing strong teams and metrics to foster environment of continuous improvement
Develop and maintain engineering team to advance investigation techniques for execution by direct labor workforce
Support CAPA initiatives and ongoing projects to ensure ongoing proficiency in complaint investigations operation
Represent Complaint Investigations lab for audits, projects, and generally acting as subject matter expert for complaint investigations processes
Develop metrics and presentations for Quality System Management reviews and associated requirements to ensure compliance and maintain performance
Reviews and provides functional approval for project and quality system documentation
Develops and implements plans, ensures milestones are met and prioritizes resource workload as required to meet commitments
Measures and reports performance of personnel and process relative to targets
Sustain the complaint investigation operation, develop a team and lead projects to advance the lab for future expectations with regards to compliance, capabilities, and workforce output
Oversee engineers and leads for direct and indirect labor to sustain complaint investigations, and complaint returns
Establish an operation that performs consistently to maintain requirements for investigation timeliness, and develop processes for new or updated products, while ensuring ongoing compliance and audit readiness per Abbott's Quality Policies and Global Regulations

Skills

Key technologies and capabilities for this role

Quality AssuranceComplaint InvestigationsRegulatory ComplianceTeam LeadershipProcess DevelopmentProject ManagementRoot Cause Analysis

Questions & Answers

Common questions about this position

What benefits does Abbott offer to employees?

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

What is the salary range for the Quality Assurance Manager position?

This information is not specified in the job description.

Is this Quality Assurance Manager role remote or onsite?

This information is not specified in the job description.

What are the main responsibilities of the Quality Assurance Manager?

The role involves overseeing complaint investigation lab output by developing teams and metrics for continuous improvement, maintaining engineering teams for investigation techniques, supporting CAPA initiatives, representing the lab in audits as a subject matter expert, and developing metrics for Quality System Management reviews.

What does Abbott's company culture emphasize?

Abbott emphasizes doing work that matters, opportunities to grow and learn, 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.

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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