Abbott
Healthcare
StaffQualityEngineer
“Staff Quality Engineer at Abbott. Skills: Process/Quality Engineering, Problem Solving, CAPA, Data Analytic Tools, Statistical Analysis. Develop and implement strategies for Process/Quality Engineering that help to ensure delivery of highest quality product to the customer. 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 acti”
What You'll Achieve.
Reduces and controls Manufacturing process defects (scrap, nonconforming material, customer complaints); Ensure delivery of highest quality product to the customer; Ensure compliance with U. S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
Industry & Context.
Structured Problem Solving; Identifying primary root causes; Implementing corrective and preventative actions; Identifying issues through data queries and analytics; Devising methods to reduce process variation; Identifying methods to capture quality metric data; Performing appropriate analysis methods to enhance sustaining product quality
Will perform this job in a quality system environment, Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day), Travel: Yes, 10 % of the Time
What They're Looking For.
Must Have
Bachelor’s degree in Engineering or related field or an equivalent combination of education and work experience, Minimum 9 years Related work experience with a understanding of specified functional area, Related work experience with a complete understanding of specified functional area, Comprehensive knowledge of a particular technological field, Is recognized as an expert in work group and across functions, Will perform this job in a quality system environment, 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
Nice to Have
Medical Device experience, highly preferred, Has demonstrated experience of statistical analysis and problem-solving techniques, Understands the regulated business environment and interfaces with a variety of management levels, requiring the coordination of activity across the organization, Provides Quality leadership across the organization, Practical understanding of statistics, Six Sigma Green Belt or Black Belt Certifications, preferred
What You'll Do.
Develop and implement strategies for Process/Quality Engineering that help to ensure delivery of highest quality product to the customer
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 through structured Problem Solving
Develop product quality plans
and systems by creating product specifications
quality specifications
and quality plans for internal development
Clinical Product Development (CPDP)
and design change projects
Accountable for Design Verification a Validation (V&V) activity planning & execution
including identifying root causes and implementing corrective and preventative actions
Lead design test and inspection method development
and lead method validation activities
and analyzing various types of process validation protocols
Ensure Design History File (DHF) content completion
and regulatory & standards compliance with FDR 21 CFR 820
and Good Manufacturing Practices (GMPs)
Support and ensure internal and external audit responses
Support and ensure on time product re-certifications
Responsible for identifying issues through data queries and analytics to aid in decision making
implement complex product stops & develop release criteria
Develops and implements Process Monitoring Systems or other early warning systems that can detect and identify critical process inputs and devising methods to reduce process variation in order to reduce/eliminate the cause of defects
Leads Product/Process improvement efforts by identifying methods to capture quality metric data and by identifying & performing appropriate analysis methods to enhance sustaining product quality
Complete Document Change Request Reviews in a timely and objective manner
Support/lead all Company initiatives as identified by management and in support of Quality Management Systems (QMS)
Environmental Management Systems (EMS)
and other regulatory requirements
Ensure compliance with U. S. Food and Drug Administration (FDA) regulations
other regulatory requirements
and lead junior Quality Engineers
How You'll Work.
Team & Collaboration
Coaches and develops cross-functional teams with expertise in problem solving, CAPA, and data analytic tools; Understands the regulated business environment and interfaces with a variety of management levels, requiring the coordination of activity across the organization; Provides Quality leadership across the organization
Process & Methodology
Design Verification a Validation (V&V) activity planning & execution
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