Quality Engineer

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 114,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

The Opportunity

The Quality Engineer in Itasca, IL is involved in all aspects of the manufacturing operation from assessing equipment needs, to documenting installation, qualification, and ongoing validation of equipment and processes. The Quality Engineer is also expected to assist in the identification and resolution of quality related issues.

What You'll Do

• Interfaces with Safety Regulatory Agencies as required ensuring compliant product is released (i.e. • Provides quality engineering support to the site to ensure manufacturing/quality requirements are met.
• 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.
• Implements Process Monitoring Systems by identifying critical process steps which could culminate in possible sources of manufacturing defects and devising methods to reduce process variation in order to reduce/eliminate the cause of defects.
• Contribute to the development of appropriate reliability program for the division/site.
• Lead/Assist in writing, executing, and analyzing various types of protocols (i.e. engineering studies, verification protocols, validation, etc.).
• Reduces and controls manufacturing process defects (scrap, nonconforming material, customer complaints) by assisting efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions.
• Helps assure that Division projects meet scheduled dates and are compliant with the regulations.
• May be involved in all levels of projects from simple design changes to total design changes. Responsible for the Receiving Inspection and ensure compliant process in place.
• QA Warehouse including GSP, GDP & GMP, QA Review, Relabeling, and Addendum Labeling areas at the Abbott Itasca Distribution Center
• Support Maintaining GSP, GMP & GDP license.
• Conduct Gemba and walk through frequently and highlight the identified issues to the area owner.
• Implement the applicable Quality systems in place.
• Perform and support the investigation process for nonconformities, identify the root causes and work cross functionally for CAPA implementation.
• Supervised, trained, and developed personnel by assigning goals, monitoring employee performance, providing feedback, writing development plans and performance reviews, and managing employee HR issues
• Managed and assigned resources to address business needs, overtime needs, and project support
• Owned all site quality metrics and presented them at the monthly business review forum
• Assisted in engineering work across the site including impact assessments, change orders, owning CAPAs, line support, and engineering project work
• Supported internal and external audits as backroom table lead and front room inspection administrator.
• Ensure Material Control system implementation including but not limited to storage conditions are maintained as per label claim, Receiving, Returns, Rejections, Disposition and Destruction.

Required Qualifications

• Bachelor's Degree
• Minimum of 2 years' experience
• Working knowledge of applicable regulations, compliance requirements, quality systems, and engineering / quality principles as relates to applicable manufacturing environment, preferably consumable goods.
• Experience with good distribution practices

Preferred Qualifications

• Bilingual

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:  http://www.abbottbenefits.com/pages/candidate.aspx

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.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

$66,700.00 – $133,300.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:Operations Quality

DIVISION:AMD Molecular

LOCATION:United States > Itasca - AMDC : 1015 West Devon Ave

ADDITIONAL LOCATIONS:

WORK SHIFT:Standard

TRAVEL:No

MEDICAL SURVEILLANCE:Not Applicable

SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf