Compliance Quality Software Lead at Abbott

Alameda, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, DiagnosticsIndustries

Requirements

Expertise in quality engineering for software QA (SWQA) in computerized systems supporting Quality Systems and customer-facing products
Knowledge of regulatory requirements such as ISO 9001/13485, FDA 21 CFR Part 820, and IVD/MDD directives
Ability to work independently with objectives from Quality management
Experience as a senior-level Quality Lead for medical device software, firmware, and mobile applications (Android/iOS)
Capability to plan, coordinate, and direct own work and that of team members, including contract personnel, according to project schedules

Responsibilities

Ensure SWQA computerized systems are developed, validated, and maintained in compliance with regulatory and corporate requirements
Provide quality engineering expertise to investigate, audit, analyze, propose improvements, and manage processes in Quality Management Systems and development of ADC consumer products and mobile applications
Identify and implement initiatives for continuous improvement
Author, change, and update software QA procedures as applicable
Ensure compliance with Abbott Diabetes Care Quality Management policies and applicable regulatory/corporate requirements
Serve as primary representative for software quality assurance on assigned Product Development Teams, ensuring quality functions are integrated at appropriate phases and represented at Phase Reviews
Evaluate complaints, CAPAs, internal audit findings, and customer audit findings; propose corrective and preventive actions
Analyze, monitor, and report status and issues on software-related projects to upper management
Develop and implement Verification and Validation policies, status reports, and strategies; review and approve validation protocols/reports
Build and maintain cross-functional relationships with departments such as R&D, System Engineering, Product Quality, Technical Quality, CAPA, and Regulatory Affairs
Assume Quality Lead responsibilities for project teams on ADC products incorporating software/firmware and mobile applications
Act as SWQA lead for multiple SWQA initiatives, ensuring accuracy, clarity, consistency, completeness, and compliance across multiple projects
Complete and ensure SWQA tasks in accordance with current Quality System Requirements

Skills

Software Quality Assurance

Computerized Systems Validation

Quality Management Systems

Regulatory Compliance

Quality Engineering

Auditing

Process Improvement

Mobile Applications

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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