Quality Engineer II, Risk Management at Abbott

San Diego, California, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Bachelors’ degree in Engineering or related field or an equivalent combination of education and work experience
2 years’ experience working in a broader enterprise/cross-division business environment
Knowledge of GMP, ISO, FDA regulations, and quality systems auditing is desired
Must possess good communication and analytical skills
Ability to work under deadlines
Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
Demonstrates technical leadership within the department and outside the department
Ability to work in a highly matrixed and geographically diverse business environment
Ability to leverage and/or engage others to accomplish projects
Strong organizational and follow-up skills, as well as attention to detail

Responsibilities

Perform risk evaluations associated with complaints, manufacturing non-conformances and new product design activities
Proactive in finding quality improvements related to Risk Management processes
Works cross functionally with Engineering, Marketing, Manufacturing and Regulatory to establish product risk documentation
Work collaboratively with operations engineering, complaint handling team, product development and design assurance
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, and contractors
Work closely with cross functional teams to establish and ensure compliance and quality for product related risk management documentation
Ensure risk management assessments and evaluations for products conform to established standards and agency regulations

Skills

Risk Management

FMEA

ISO 14971

Quality Engineering

Complaint Handling

Non-conformance Investigation

Product Design

Cross-functional Collaboration

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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