Abbott

Sr. Quality Engineer

Temecula, California, United States

Not SpecifiedCompensation
Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, Quality Engineering, Regulatory AffairsIndustries

Requirements

Candidates should possess a Bachelor’s degree in Engineering, preferably Biomedical, Mechanical, or Chemical, and have a minimum of 8 years of experience in quality engineering, specifically within the medical device industry. Strong knowledge of regulatory requirements such as FDA regulations, ISO 13485, and risk management principles is essential. Experience with data management systems and cybersecurity protocols is also required.

Responsibilities

The Senior Quality Engineer will perform Abbott Vascular data management quality engineering activities by developing and maintaining data integrity and cybersecurity policy, standards, applications, systems, etc. They will work closely with R&D, Equipment Engineering, Quality Engineering, and BTS on risk identification and mitigation activities, facilitate cross-functional team collaboration to achieve data management goals, support AV data management project plan and perform assessment and mitigation with cross functional team, develop and manage data management training program including training material and training audience, track and report data management metrics, provide support to internal and external audits, manage data management audit findings and CAPAs, continuously improve data management process to align with current and emerging regulatory and customer requirements and best industry practices, and collaborate with AV key stakeholders, Abbott corporate functional groups, and other Abbott business units.

Skills

FDA Regulations
ISO 13485
Risk Management
Data Management Systems
Cybersecurity Protocols
Data Integrity
CAPA Management
Data Management Training
Audit Support
Data Management Metrics
Cross-functional Collaboration
Data Management Process Improvement

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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