Senior Quality Engineer Risk Management at Abbott

Pleasanton, California, United States

Abbott Logo
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Healthcare, Medical DevicesIndustries

Requirements

  • Bachelor's degree in engineering or Technical Field
  • 5+ years in related work experience
  • Risk management (ISO 14971)

Responsibilities

  • Implement and maintain the effectiveness of the Risk Management Quality System element
  • Interpret regulations and requirements to lead, coach, and mentor teams on Risk Management
  • Serve as SME for domestic/international sites and affiliates regarding Risk Management Quality System element
  • Work cross functionally with development/manufacturing/quality/regulatory/clinical to establish product risk documentation
  • Mentor, coach and train new product development teams and sustaining engineering teams to create or maintain product risk assessments
  • Perform Health Hazard and Regulatory Risk Evaluations

Skills

Risk Management
Quality Systems
Quality Engineering
New Product Development
Manufacturing
Post Market Support

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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