Quality Engineer at Abbott

Roseville, Minnesota, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical Devices, DiagnosticsIndustries

Requirements

Minimum 5 years of experience preferred
Wide application of technical principles, practices, and procedures
Strong knowledge of quality systems environment
Ability to work on problems of diverse scope where analysis of data requires evaluation of identifiable factors
Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions
Sound knowledge of various technical alternatives and their impact

Responsibilities

Support QMS Implementation and maintenance of applicable distribution sites, including documentation updates, new releases of documents, QMS reviews for audit preparation, and participation in internal and external agency audits
Reduce and control distribution process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying primary root causes and implementing corrective and preventative actions
Execute qualification/validation activities to support distribution projects and internal process implementation driven by the business units
Own and execute improvement activities (CAPA/NCMR), performing root cause analysis and implementation of solutions to mitigate risk
Analyze complex interdisciplinary problems, identify their impact, establish probabilities, draw conclusions reflecting broad business needs, and understand organizational and financial impact of recommendations (e.g., apply regulatory requirements and recommend best course of action)
Responsible for product stops ship execution (containment, releases, disposition executions such as scrap, rework, sort)
Develop and implement quality plans, documents, and systems by creating quality specifications, risk analyses, and FMEAs in conjunction with cross-functional teams
Responsible for risk analyses and FMEAs of distribution processes
Develop and implement Process Monitoring Systems by identifying critical process steps that could culminate in possible sources of distribution defects and devising methods to reduce process variation
Collect and analyze process defect data (e.g., scrap, nonconforming product, customer complaints) by systematically gathering quality metric data and performing appropriate analysis methods to enhance sustaining product design and new product development
Create Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams
Participate in the development of less experienced staff by setting an example, providing guidance, work direction, and offering counsel; may lead a project team
Participate in determining goals and objectives for projects; influence middle management on technical or business solutions
Interact with business units/manufacturing sites to support product flow or dispositions through distribution
Plan and organize non-routine tasks with approval; initiate or maintain work schedule; establish priorities of work assignments

Skills

Key technologies and capabilities for this role

QMSRoot Cause AnalysisCAPAFMEARisk AnalysisProcess ValidationInternal AuditsCorrective ActionsQuality EngineeringNCMRQuality Systems

Questions & Answers

Common questions about this position

What is the employment type for this Quality Engineer position?

The position is full time.

Is this Quality Engineer role remote or office-based?

This information is not specified in the job description.

What key skills are required for the Quality Engineer role?

Key skills include process/quality engineering, root cause analysis, CAPA/NCMR execution, risk analyses and FMEAs, and qualification/validation activities.

What is the company culture like at Abbott?

Abbott is a global healthcare leader with 114,000 colleagues serving people in more than 160 countries, focused on life-changing technologies across diagnostics, medical devices, nutritionals, and medicines.

What makes a strong candidate for this Quality Engineer position?

Strong candidates have experience analyzing complex interdisciplinary problems, leading teams on corrective actions, developing quality plans and FMEAs, and mentoring less experienced staff.

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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