Abbott Senior Operations Quality Engineer 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 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.
This position is responsible for supporting sustaining activities for the Operations Quality Engineering group.
Lead all activities for Non-Conformance Material Report’s (NCMR’).
Participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality function as a Core Team Member)
Support CAPA Teams that are addressing manufacturing or design related issues.
Lead Test Method Validation (TMV) and Inspection Method Validation (IMV) activities.
Review and approve Process Failure Mode and Effects Analysis (pFMEA)Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Product Performance Qualification (PPQ).
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
Develop Product Risk Assessment’s for patient safety for CAPA’s and other projects.
Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
Performs other related duties and responsibilities, on occasion, as assigned.
Lead projects within the Operations Quality Engineering group
BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred
Minimum 7 years experience
Quality Engineering experience supporting sustaining production activities.
Solid communication and interpersonal skills
Project management and leadership skills
Computer skills, including statistical/data analysis and report writing skills
Prior medical device experience preferred
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.
Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner.
Strong organizational and follow-up skills, as well as attention to detail.
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 at 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 at http://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.
To request accommodation, please call 224-667-4913 or email email@example.com