Operations Quality Engineer II

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:

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 103,000 colleagues serve people in more than 160 countries.

Leading an active lifestyle is important to the many people we serve. In Abbott’s Heart Failure division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in Electrophysiology & Hear Failure, allowing people to restore their health and get on with their lives.

For years, Abbott’s Medical Device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine finger sticks.

JOB SUMMARY

This position is responsible for supporting sustaining activities for the Operations Quality Engineering group.

JOB DUTIES

·  Non-Conforming Material Reports (NCMR) including; root cause investigation, risk assessment, historical record review, disposition strategy, correction activities.
·  Complaints Reviews/Manufacturing Analysis/Field Impact Escalation including; event assessment, root cause investigation, risk assessment, historical record review, impact/action escalation.   
·  Corrective Action Preventive (CAPA); including root cause investigation, scoping/bracketing, resolution planning, implementation, and verification of effectiveness.
·  Regulatory requests including; certification of compliance and product inquires.
·  Manufacturing/Production Line Support – partnering with operations team members to achieve value stream goals and objectives.
·  Change Control – lead documentation change orders per quality system requirements using PLM system.
·  Validation/Qualification – Lead/review Installation Qualification, Process Qualification, Operational Qualification, Product Performance Qualification (PPQ), Master Validation Plan/Report, and Test/Inspection Method Validation.
·  Risk Management – use and interpret Hazard Analysis, use/update/create Failure modes and Effects Analysis.
·  Voice of Quality, Quality 1st mindset.
·  Support backroom during audits.
·  Line Reviews – supports timely completion of manufacturing front line personnel reviews

QUALIFICATIONS

Required

·  Medical Device Experience – knowledgeable of quality system requirements and external regulatory requirements, i.e. ISO, FDA.
·  BS degree in Engineering or Technical Field or equivalent experience.
·  2 years (minimum) of experience within medical device operations quality engineering function supporting manufacturing of finished goods. Experience includes the following; non-conforming material investigations/disposition, process and test method validation protocol/report execution/writing, risk management FMEA utilization.

Preferred

·  Verbal and Technical Writing – strong verbal and technical writing including; presentations, graphs/charts, and protocols/reports
·  Multitasks, prioritizes and meets deadlines in timely manner.
·  Strong organizational and follow-up skills, as well as attention to detail.
·  Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
·  Ability to leverage and/or engage others to accomplish projects.
·  Project Management – ability to partner with cross functional team member and set realistic action plans including identifying resources and target due dates.
·  Computer Skills – ability to use email and standard office programs
·  Statistical method – data analysis, including normality/capability assessments.
·  Continuous Improvement – knowledgeable of methodology and industry best practices.
·  Advance degree

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 on-boarding 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. 

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:

EPHF Electrophysiology & Heart Failure

        

LOCATION:

United States > Minnesota > Plymouth : 5050 Nathan Lane N

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Yes, 5 % of the Time

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours 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