Sr. Quality Engineer

Temecula, California, United States

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$60,000 – $90,000Compensation

Senior (5 to 8 years), Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Quality EngineeringIndustries

Requirements

Candidates should possess a Bachelor’s degree in Engineering, preferably Biomedical or Mechanical, and have a minimum of 8 years of experience in quality engineering, specifically within the medical device industry. Strong knowledge of quality systems, including ISO 13485 and FDA regulations, is essential, along with experience in data management and risk mitigation.

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, and systems. They will work closely with R&D, Equipment Engineering, and Quality Engineering teams to identify and mitigate risks, facilitate cross-functional collaboration, support data management project plans, develop and manage data management training programs, track and report metrics, and provide support for internal and external audits. Additionally, the role involves managing data management audit findings and CAPAs, continuously improving data management processes, and collaborating with key stakeholders and Abbott business units while ensuring compliance with relevant policies and procedures.

Skills

ISO 13485

FDA Regulations

Data Integrity

Risk Mitigation

Data Management

CAPA Management

Auditing

Quality Systems

Cybersecurity Policy

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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