Abbott Quality Engineer II, Risk Management - Heart Failure in Pleasanton, California
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.
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 heart failure, allowing people to restore their health and get on with their lives.
We are seeking a highly motivated Quality Engineer to support Risk Management team . You will work closely with development/manufacturing/quality engineering to establish and ensure compliance and quality for product related risk management documentation. Ensure risk management assessments and evaluations for products conform to established standards and agency regulations.
WHAT YOU’LL DO
Perform risk evaluations associated with complaints, manufacturing non-conformances and new product design activities.
Proactive in finding quality improvements related to Risk Management processes.
Works cross functionally with Engineering, Marketing, Manufacturing and Regulatory to establish product risk documentation.
Work collaboratively with operations engineering, complaint handling team, product development and design assurance.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Perform risk management activities to drive collaborative discussions on appropriate mitigation strategies.
Conducts special analyses and projects as required.
Resolves and/or facilitates resolution of problems including identifying causes to prevent re-occurrence.
Performs other related duties and responsibilities, on occasion, as assigned.
Maintains risk documentation and establishes procedures that affect department.
EDUCATION AND EXPERIENCE, YOU’LL BRING
A Bachelor's degree in an applicable engineering discipline with minimum 2 plus years of progressively more responsible work experience in quality assurance and design related to medical devices, preferably in electro-mechanical and implantable medical devices (class III and IV).
Preferably in an Implantable Medical device, regulatory environment or pharmaceutical manufacturing. Preferred understanding of complaint management and Health Hazard Assessments for on-market (distributed) product.
Excellent verbal and written communicator; clear and concise in communications with internal and external partners.
Desired: An advanced credential in a relevant discipline/concentration. Professional certification or designation, such as CQE, CSQE, CRE and/or CMQ/OE.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to work effectively within a team in a fast-paced changing environment.
Multi-tasks, prioritizes and meets deadlines in timely manner.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
A fast-paced work environment where your safety is our priority
Production areas that are clean, well-lit and temperature-controlled
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 (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.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
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