Quality Engineer III

Abbott; Alameda (CA); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Flexible Spending Accounts

Life Insurance

Short Term Disability

Long Term Disability

Critical Illness, Hospital coverage

401(k)

Job summary

Abbott is seeking a Quality Engineer III for a 12-month onsite assignment in Alameda, CA. You will independently review and approve analytical method validation/transfer, assess statistical data, and collaborate with QC, Manufacturing, R&D, and Regulatory Affairs to ensure regulatory compliance and product quality.

The role emphasizes risk-based decision making, data integrity, and applying GMP/ICH guidance to analytical methods across medical devices and diagnostics.

Qualifications

• Bachelor's degree in a scientific discipline with 7+ years in regulated quality roles.
• Experience reviewing analytical method validation, verification and transfer documentation.
• Strong knowledge of FDA/ISO/GMP/ICH requirements for analytical methods and lab controls.
• Experience with method validation per ICH Q2(R2), USP, and FDA guidance preferred.

Responsibilities

• Review/approve analytical method validation, verification, qualification and transfer protocols and reports.
• Provide technical assessment of validation studies for methods used in medical devices, pharma, and diagnostics.
• Evaluate validation parameters and statistical analyses; ensure scientifically sound conclusions.
• Lead investigations of deviations, OOS/OOT, CAPA and nonconformances with cross-functional teams.
• Support method transfer between labs, contract testing organizations, and manufacturing sites.
• Ensure compliance with regulations including FDA QSR, 21 CFR Parts 210, 211, 820 and ISO 13485.

Skills

Strong written and verbalCommunication

Statistical analysis

Risk-based decision making

Independent problem solving

Quality systems proficiency

Education

Bachelor's degree in Chemistry/Biochemistry/Biomedical Engineering or related

Advanced degree preferred (MS or PhD)

Tools

HPLC

Dissolution testing

Wet chemistry

Microbiological methods

Statistical software

Job description

Title: Quality Engineer III

Location: Alameda, CA

Duration: 12 Months

100% Onsite

Responsibilities:

• Independently review and approve analytical method validation, verification, qualification, and transfer protocols and reports to ensure compliance with internal procedures and regulatory requirements.
• Provide technical assessment of validation studies for analytical methods used in medical device, combination product, and pharmaceutical manufacturing processes.
• Evaluate validation parameters including accuracy, precision, specificity, linearity, range, robustness, ruggedness, detection limits, quantitation limits, and method suitability.
• Review statistical analyses supporting method validation and process capability assessments, ensuring scientifically sound conclusions and appropriate interpretation of data.
• Partner with Quality Control, Manufacturing, R&D, Process Development, Regulatory Affairs, and Quality Engineering teams to resolve complex technical challenges related to analytical methods and testing processes.
• Assess method performance during investigations, deviations, OOS (Out-of-Specification), OOT (Out-of-Trend), CAPA, and nonconformance activities.
• Provide quality oversight and guidance for analytical method transfer activities between laboratories, contract testing organizations, and manufacturing sites.
• Support design transfer and process validation activities through evaluation of inspection, test, and measurement methods used to establish product acceptance criteria.
• Ensure compliance with applicable regulations and standards, including FDA Quality System Regulation, 21 CFR Parts 210, 211, 820, ISO 13485, and applicable ICH guidance.
• Drive consistency and continuous improvement in validation practices, statistical tools, templates, and review processes across the organization.
• Participate in internal audits, regulatory inspections, and quality system assessments related to laboratory controls, analytical methods, and validation programs.
• Author and review technical justifications, risk assessments, validation summaries, gap assessments, and procedural documents.
• Ensure all documentation is completed accurately, thoroughly, and in accordance with document control and data integrity requirements.
• Work independently under general direction while providing technical recommendations and quality risk assessments to management and project teams.

Required Qualifications

• Bachelor’s degree in Chemistry, Biochemistry, Biology, Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences, or a related scientific discipline.
• Minimum 7 years of experience in Quality, Analytical Development, Validation, Quality Control, or Quality Engineering within a regulated medical device, biopharmaceutical, pharmaceutical, diagnostics, or combination product environment.
• Demonstrated experience reviewing and approving analytical method validation, verification, and transfer documentation.
• Strong working knowledge of FDA, ISO 13485, GMP, GLP, and ICH requirements related to analytical method validation and laboratory controls.
• Experience with analytical techniques such as HPLC, dissolution, wet chemistry, microbiological methods, particulate testing, or other relevant laboratory methodologies.
• Strong understanding of statistical analysis principles and their application to analytical method validation and process monitoring.
• Experience evaluating technical data packages, identifying compliance risks, and providing scientifically justified recommendations.
• Knowledge of software validation and data integrity requirements, including 21 CFR Part 11.
• Demonstrated ability to independently analyze complex technical issues and make risk-based quality decisions.
• Strong written and verbal communication skills with the ability to communicate effectively across technical and non-technical functions.
• Proficiency with quality systems, electronic document management systems, statistical software, and laboratory data management tools.
• Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.

Preferred Qualifications

• Advanced degree (MS or PhD) in a scientific discipline.
• ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent certification.
• Experience supporting combination products or diagnostic medical devices.
• Experience with method validation under ICH Q2(R2), USP, and FDA guidance.
• Experience supporting regulatory inspections and responding to agency observations.
• Working knowledge of Design Control, Design Transfer, Process Validation, and Risk Management principles.

Consultants Eligible Benefits Upon Waiting Period:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.