Supplier Quality Engineer

Job description

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 107,000 colleagues serve people in more than 160 countries

     

JOB DESCRIPTION:

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.

Our location in Irving, TX, currently has an opportunity for Supplier Quality Engineer.

WHAT YOU’LL DO

The Supplier Quality Engineer is responsible for activities related to supplier evaluation, performance and improvements. Contributes to the development, establishment and maintenance of supplier quality engineering methodologies, systems and practices which meet Abbott and regulatory requirements. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success for assuring high product quality and meeting business needs.

Responsibilities:

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Non-conforming materials management - Supports incoming Non-Conforming Material Report (NCMR) activities, responsible for Material Review Board (MRB) and related corrective and improvement actions with suppliers

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Supports operations in supplier related issues, communicates non-conformances identified during manufacturing and drives resolution in partnership with cross-functional team and supplier

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Performance monitoring and corrective actions - Monitors supplier performance (scorecard) to drive supplier corrective action, manufacturing yield issues and field failures.

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Supplier Audit management - Supports Supplier Audit management and corrective actions identified from supplier audits

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Supplier Quality Agreements - Participates in the evaluation and development of Supplier Agreements with suppliers.

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Support internal and external Quality Management System and Regulatory audits as needed

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Continuous improvement - Works with suppliers, design engineers, supplier quality and purchasing to implement changes that will improve quality, yields and cost of the product. Activities include Gage Repeatability & Reproducibility, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Process Capability (Cpk analysis), etc.

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Assesses potential new suppliers and service providers for quality and quality system capabilities through the execution of on-site or desk top audits, and review of other objective evidence, as required.

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Communicates Division approval requirements to supplier and monitors feedback per project timelines.

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Performs on-site quality assessments of new suppliers, as required, and ensures appropriate corrective action response to findings.

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Ensures Document Control is notified of any changes to supplier statuses, as they relate to the Agile Manufacturer’s Tab.

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Evaluates Exception Reports (ERs) issued for nonconforming supplied material and works with the supplier on the investigation and resolution of root cause issues.

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Notifies suppliers of customer complaints related to failures resulting from supplied material and requires investigation and corrective action.

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Monitors supplier performance and reports supplier quality trend data.

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Participates with Incoming Quality Control on the development of incoming inspection activities or the reduction of these activities through implementation and maintenance of the Material Certification Program.

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Responsible for approving First Article Inspections and/or Golden Samples, as initiated by suppliers.

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Assists with the evaluation and approval of supplier requested changes or improvements.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

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Bachelor’s degree; Science or Engineering discipline is preferred

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Minimum 2 years of related work experience

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Quality Assurance experience in the medical device or pharmaceutical, or other quality managed industries.

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Working knowledge of applicable regulations, such as FDA QSR, ISO, MDD, &/or IVDD. 

· 
Well developed written, oral and interpersonal skills.

Preferred

· 
3+ years’ work experience in Quality or related field experience

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2+ years professional experience from companies that manufacture complex electromechanical instruments (e.g., medical device, aerospace, robotics, automotive, commercial vehicle/diesel engine)

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Ability to travel up to 25%

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Bachelor’s or master’s degree in one of the following Engineering disciplines: Electrical, Industrial, Mechanical or Bio-Medical

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Knowledge of FDA, GMP, & ISO 13485

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Six Sigma Green or Black Belt is desired

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Experience working with printed circuit boards, pumps, motors, solenoids, sheet metal mfg., machined parts (both metal and plastic), or injection molding are all desired

· 
Strong technical writing skills; Polished verbal and written communication skills

· 
Proactive, self-driven results seeking and enthusiastic person who enjoys collaborating with teams, driving improvement and delivering impact.

WHAT WE OFFER

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

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Training and career development , with onboarding programs for new employees and tuition assistance

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Financial security through competitive compensation, incentives and retirement plans

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Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

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Paid time off

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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.

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

     

JOB FAMILY:

Operations Quality

     

DIVISION:

ADD Diagnostics

        

LOCATION:

United States > Irving : LC-8

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 25 % of the Time

     

MEDICAL SURVEILLANCE:

No

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

     
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