Quality Systems 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:

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of STRUCTURAL HEART disease.  We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.

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 Responsibilities:

•           Perform and assure timely follow-up activities in support of key quality and compliance metric/data goals and policy/procedural requirements

•           Assists with Quality System activities, projects, and initiate document changes

•           Supports the coordination of the external audits/inspection preparation and provides back room support as required

•           Track and follows up on audit finding responses to ensure timely closure of audit observations

•           Assist in the initiation, processing and completion of Internal/External Audit responses and records in the EPIQ electronic system.

•           Supports investigating and resolving system nonconformities (defined during internal and/or external audits)

•           Supports in data and metric analysis.  Analyze quality data and generate metric reports and presentations to support Management Reviews.

•           Complete trend analysis of data as appropriate to ensure proper actions can be determined or assessed

•           Helps with the resolution of problems including identifying causes to prevent re-occurrence

•           Performs related functions and responsibilities as assigned.

•           Complies with U.S. Food and Drug Administration (FDA) regulations, all other applicable regulatory requirements (including non-US regulations, company policies, operating procedures, processes, and task assignments.

•           Responsible for completing documentation in a timely manner and in accordance with business standards.

•           Travel up to 5% of the time both domestically and internationally by any means necessary to support organizational goals

Education:

Bachelor’s Degree in Engineering or Technical Field or an equivalent combination of education and work experience   

Experience/Background:
 

Two to Five Years’ Experience with:  

•           Relevant Quality Assurance/Quality Systems/ Quality Engineering experience and demonstrated use of quality tools/methodologies.

•           Working knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485:2016.

Preferred Skills/Experience:     

•           Technical report writing skills, strong organizational skills and follow-up skills, as well as attention to detail.

•           Multitasks, prioritizes and meets deadlines in timely manner.

•           Knowledge of EUMDR and MDSAP regulations

•           Solid communication and interpersonal skills.

•           Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior.

•           Project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.

•           ASQ, CQE or CQA

•           Certification as a quality engineer (e.g. CQE) or Quality Auditor (CQA)Certification granted through the American Society of Quality (ASQ)

•           Medical Device Quality Experience

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:

SH Structural Heart

        

LOCATION:

United States > Minnesota> St. Paul > Woodridge : 177 East County Rd B

     

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