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.
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.
- BS degree in Engineering or Technical Field or equivalent experience; advanced degree preferred
- 2-5 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.
JOB FAMILY:Operations Quality
DIVISION:EPHF Electrophysiology & Heart Failure
LOCATION:United States > Pleasanton : 6035 Stoneridge Dr
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