Quality Engineer III

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.