Quality Engineer, Medical Device Design Control

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, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

About Abbott Diagnostics

The key to successful treatment and full recovery is often fast, accurate diagnosis. Abbott's life-changing tests and diagnostic tools provide insights that enable smarter, faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations - with medical diagnostic instruments, tests, automation and informatics solutions for hospitals, reference labs, blood centers, emergency departments, physician offices and clinics.

Location / Summary

Our location in Abbott Park (Lake County), IL currently has an opportunity for Design Control Professional within Research and Development who will be responsible for implementing and maintaining the effectiveness of the quality system. This role will be responsible for:

• Design Control: Develops and implements new product design plans to assure low cost; robust specifications; reproducibility; and high-quality products that meet customer expectations.
• Documentation & Change Control: Understands and assesses the impact of changes on validation and manufacturability of a product. Analyzes data and draws conclusions. Assesses the impact of changes on product stability and dating. Able to identify critical parameters which define optimal reagents; primaries; panels; and references to assure consistent product performance across lots.
• Corrective & Preventative Action: Identifies issues and guides teams to understand the root cause and resolution. Responsible for CAPA activities. CAPA activities include, nonconformance's, potential nonconformances and investigations.
• Regulatory: Assesses the regulatory risk associated with change documents; defends rationale and compliance to internal and external auditors.
• Quality: Understands and meets current quality requirements to promote conformance to customer; regulatory and divisional requirements.; Makes Decisions: Bases decisions on the overall good; rather than on benefit to a particular functional area; serves as a champion for specific projects and initiatives.
• Quality System: Understands; implements; and maintains the quality policy. Ensures compliance to and is able to demonstrate knowledge of site level policies and procedures.
• Technical: Reviews and analyzes data; draws effective conclusions. Understands experimental design. Can apply knowledge to data analysis and problem-solving situation. Working application of statistical tools (SPC; DOE; Basic Stats; ANOVA). Utilizes comprehensive process knowledge and detailed understanding of multiple technologies in failure analysis; specification setting; and product development/improvement. Applies statistical tools; data analysis methods; knowledge of clinical applications; and technical writing skills to address failure analysis; spec. setting; and product development/improvement. Understands the consequences of product issues on product performance; customer acceptance; customer risk; compliance; and manufacturability. Proficient at Hazard Analysis. Applies creative technique to problem solving and issue resolution. Understands the impact of testing and process variation on manufacturability and field performance.

What You'll Do

• Assay Development Design Control core team member responsible for Design Control activities, which may include design inputs, design planning, design change requests, deliverables, design reviews.
• Has an in-depth understanding of diagnostic products; processes and technologies. Is able to support multiple products and projects.
• Utilizes statistical tools to analyze data.
• Understands multiple technologies and instrument platforms.
• Knows both qualitative and quantitative products. Is aware of competitor's products perceived strengths and weaknesses.
• Understands quality control procedures and manufacturing processes for final product.
• Has an in-depth understanding of; and can assess justifications on change documents.
• Must be able to identify issues; assess risk; make recommendations; and elevate issues as required. Has knowledge of clinical applications for products for which they are responsible.
• Understands intended use and off-label uses of products.
• Responsible for implementing and maintaining the effectiveness of the quality system.; Participates as a new product team member and can identify and elevate critical issues.
• Participates with team and assures favorable outcome.
• Interfaces in customer communication on basic performance issues.
• Participates in project and cross functional teams.
• Occasionally will interact with federal agency representatives and other external customers.
• Draws conclusion from analysis and recommends a course of action.
• Judges whether technical design of experiments are sufficient to answer the question being asked.
• Identifies root cause through use of problem-solving skills.
• Functional application of statistical tools. Functional knowledge of product reference assignment.
• Applies problem solving skills to wide variety of problems: failure investigation; product specifications and product design.
• Establishes and executes against project goals and implements plans.

Education And Experience You'll Bring

Required

• B.S. plus 4 years minimum related lab/industrial experience or M.S. with 2 years minimum relevant experience or Ph.D. in a life or physical science.
• Basic Computer skills.
• Knowledge of analytical instruments assigned by supervisor.

Preferred

• Bachelor's Degree; preferable in the life or physical sciences or closely related field or sufficient related and transferable experience.
• Experience in a technical area or quality; or clinical laboratory
• Knowledge of regulations and standards affecting IVDs and Biologics is preferred.
• Experience in Design Control, assay file development and new product development preferred.
• 1 to 3 years of experience in medical device or in-vitro diagnostics experience strongly desired
• Experience with site audits highly preferred
• Experience and proficiency with Microsoft applications (Word, Excel, PowerPoint etc.)
• Experience with Product Lifecycle Management Tools/Systems

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans

• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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