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’s 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, Process Control & Monitoring (SPC), Quality Tools
Experience with control of nonconforming material

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
Own 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
Conduct NCMR Investigations, Calibration Out Of Tolerance (OOT) Investigations, and Complaint Investigations (MA) related to manufacturing process
Complete and document Monthly Quality Data Review, providing data analysis and escalation recommendations with minimum mentorship
Lead Build At Risk (BAR) Authorizations & Closures
Complete and approve document Change Requests, assuring accuracy, adequacy, and compliance to Quality System and product requirements
Create and maintain Quality Plans and Reports, typically with minor mentorship
Execute and author IQ, OQ, PQ, and/or PPQ Qualifications and Inspection and Test Method Qualifications, typically with minimum mentorship
Conduct Statistical Data Analyses using Minitab typically with mentorship
Maintain/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 ManagementProcess ValidationCAPAProcess CapabilityStatistical AnalysisDesign VerificationDesign Validation

Questions & Answers

Common questions about this position

What are the main responsibilities of the Quality Engineer role?

The role involves working closely with Manufacturing and Engineering on sustaining activities to ensure quality system compliance and KPIs, supporting process/product validation, assisting with R&D and Regulatory Affairs for new product introductions, and supporting major quality system investigations and audits.

What skills or experiences are needed for this Quality Engineer position?

Key skills include verifying adherence to Quality System and GMP/ISO standards, conducting risk management and FMEA, supporting design verification/validation, process capability analysis, investigations like NCMR and CAPAs, and executing IQ/OQ/PQ qualifications, typically with minimum mentorship.

Is this a remote position or does it require on-site work?

This information is not specified in the job description.

What is the salary or compensation for this Quality Engineer role?

This information is not specified in the job description.

What is the company culture like at Abbott?

Abbott offers work that matters with opportunities to grow, learn, and care for yourself and family, while being your true self; it's recognized as a great place to work globally, one of the most admired companies by Fortune, and excels in diversity, working mothers, female executives, and scientists.

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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