Quality Engineer at Abbott

Roseville, Minnesota, United States

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 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 requiring evaluation of identifiable factors
Exercises judgment within generally defined practices and policies in selecting methods and techniques
Sound knowledge of various technical alternatives and their impact
Ability to perform tasks adequately to avoid noncompliance with governmental regulations

Responsibilities

Support QMS implementation and maintenance at applicable distribution sites, including documentation updates, new releases, QMS reviews for audit preparation, and participation in internal/external audits
Reduce and control distribution process defects (scrap, nonconforming material, customer complaints) by leading root cause identification and corrective/preventative actions
Execute qualification/validation activities for distribution projects and internal processes
Own and execute improvement activities (CAPA/NCMR), including root cause analysis and solution implementation to mitigate risk
Analyze complex interdisciplinary problems, assess impact, establish probabilities, draw conclusions considering business/organizational/financial impacts, and recommend actions per regulatory requirements
Responsible for product stop ship execution (containment, releases, disposition including scrap, rework, sort)
Develop and implement quality plans, documents, and systems, including quality specifications, risk analyses, and FMEAs with cross-functional teams
Perform risk analyses and FMEAs for distribution processes
Develop and implement Process Monitoring Systems by identifying critical steps, reducing variation, and eliminating defect causes
Collect and analyze process defect data (scrap, nonconforming product, customer complaints) using quality metrics and analysis methods to support product design and development
Create Quality Tools & Training Materials and communicate expertise to teams
Participate in developing less experienced staff through guidance, work direction, and leading project teams
Participate in setting project goals/objectives, influence middle management on technical/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/maintain work schedules, and establish work priorities
Exercise judgment in selecting innovative, practical methods for problem resolution

Skills

Key technologies and capabilities for this role

QMSRoot Cause AnalysisCAPAFMEAProcess ValidationRisk AnalysisInternal AuditsCorrective ActionsQuality EngineeringNCMRProduct Containment

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 quality systems support for audits and documentation.

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 in quality systems, leading cross-functional teams for root cause analysis and CAPA, executing audits, risk assessments like FMEAs, and analyzing complex problems with business impact.

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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