Senior Development Quality Engineer - Impact Healthcare

Abbott Laboratories; Menlo Park (CA); On-site; USD 90,000 - 180,000; Full time

Job summary

Abbott Laboratories in Menlo Park, CA, is seeking a Senior Quality Engineer to join the Development Quality team. The role focuses on providing development quality engineering support to manufacturing and product development, ensuring the delivery of high-quality products to customers.

You will lead quality activities across test methods, validation, risk management, and CAPA processes, collaborate with cross-functional teams, and ensure compliance with applicable regulatory standards in a

Qualifications

• Bachelor's Degree in related area or an equivalent combination of education and work experience.
• Master's Degree preferred.
• Minimum 5 years of related work experience with a complete understanding of specified functional area.
• Comprehensive knowledge of a particular technological field. Uses in-depth knowledge of business unit functions and cross group dependencies/relationships.
• Is recognized as an expert in work group and across functions. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
• Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Has broad knowledge of various technical alternatives and their potential impact on the business.

Responsibilities

• Leads Product/Process improvement efforts by identifying methods to capture quality metric data and by identifying & performing appropriate analysis methods to enhance sustaining product design and new product development.
• Develops and executes Test Methods, Test Method Validation, Design Verification and Shelf Life protocols and reports, Process Validation protocols and reports, Inspection and Control plans, Process Monitoring, and Risk Management activities.
• Creates Quality Tools & Training Materials by understanding the limitations of existing quality tools and training materials, by identifying & implementing more effective tools & materials, and by communicating new tools/materials to respective teams.
• Develops and implements product quality plans, documents and systems by creating product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members.
• Responsible for Risk Management activities including creating risk analyses and FMEAs.
• Develops and implements Process Monitoring Systems by identifying critical process and devising methods to reduce process variation in order to reduce/eliminate the cause of defects.
• Reduces and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by leading efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.
• Participates in Corrective Action/Preventative Action (CAPA) process. May be responsible for identifying issues requiring data queries & bounding to implement complex product stops & develop release criteria.
• Works as part of a cross functional team on continuous improvement initiatives.
• Complies with and ensures compliance to applicable regulatory requirements and standards.

Education

Bachelor's Degree

Master's Degree

Job description

Abbott Laboratories in Menlo Park, CA, is seeking a Senior Quality Engineer to join the Development Quality team. The role focuses on providing development quality engineering support to manufacturing and product development, ensuring the delivery of high-quality products to customers.

You will lead quality activities across test methods, validation, risk management, and CAPA processes, collaborate with cross-functional teams, and ensure compliance with applicable regulatory standards in a