Quality Engineer at Abbott

Queretaro, Queretaro, Mexico

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Bachelor degree in STEM (Science, Technology, Engineering (preferred), Math) with equivalent experience in medical devices or pharmaceutical quality control
At least 2 years of experience in Quality or Engineering positions
Proficiency in computer applications (MS Excel, MS Word, MS PowerPoint)
Knowledge of statistical/data analysis and report writing
Experience working in FDA, GMP, and ISO 13485 regulated environments
Experience in process improvement tools such as Root Cause Analysis, Fishbone, Is/Is Not, Six Sigma or Process Control & Monitoring

Responsibilities

Verify company’s adherence to the established Quality System and GMP/ISO standards
Assist in completion of risk management and risk analysis including FMEA
Work with R&D/Design verification and design validation plans for products based on performance specification and risk analysis
Support technical and statistical investigations concerning optimization and compliance to specification
Owner of measuring process capability, process controls, and process validation efforts
Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
Conducting NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations and Complaint Investigations (MA) related to manufacturing Process
Completing and Documenting Monthly Quality Data Review, providing data analysis and escalation recommendations with minimum mentorship from higher level engineering
Leading Build At Risk (BAR) Authorizations & Closures
Completion and approval of document Change Requests, assuring accuracy, adequacy, and compliance to Quality System and product requirements
Creation and maintenance of Quality Plans and Reports, typically with minor mentorship from higher level engineering
Executing and authoring IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications, typically with minimum mentorship from higher level engineering
Conducting Statistical Data Analyses using Minitab typically with mentorship from higher level engineering
Maintenance/update Master Validation Plans and Reports
Support activities during preparation and execution of audits (External / Internal)
Perform supervisor activities to Quality Technicians, if required

Skills

Key technologies and capabilities for this role

GMPISO standardsFMEARisk ManagementCAPAProcess ValidationProduct ValidationDesign VerificationDesign ValidationStatistical AnalysisQuality SystemAudits

Questions & Answers

Common questions about this position

What are the main responsibilities of the Quality Engineer role?

The role involves verifying adherence to Quality System and GMP/ISO standards, assisting in risk management including FMEA, supporting process validation, conducting investigations like NCMR and complaints, and executing IQ/OQ/PQ qualifications.

Is this a full-time position?

Yes, this is a full-time employment position.

What is the salary range for this Quality Engineer position?

This information is not specified in the job description.

What is the company culture like at Abbott?

Abbott offers career development opportunities, is recognized as a great place to work globally, and is admired for diversity, supporting working mothers, female executives, and scientists, allowing employees to do meaningful work, grow, and live fully.

What makes a strong candidate for this Quality Engineer role?

Strong candidates have experience in quality systems, process validation, risk analysis like FMEA, investigations such as NCMR and CAPAs, and can handle tasks like IQ/OQ/PQ with minimal mentorship.

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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