Abbott
Quality Engineer
United States - California - San Diego
Sponsorship not specified$82k-$141kDetected 1 day ago
Data AnalysisProject ManagementProcess ImprovementHRISGMPFDA RegulatoryMedical DevicesLeadershipCommunicationCollaborationProblem Solving
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Entry-level history0
PERM / green-card track0
Lottery odds (Level II)66
Fits your clock70
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About the role
- This position works out of our San Diego, CA location in the Infectious Disease, Diagnostics Division.
- Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.
- Investigates, and resolves system nonconformance's (defined during internal and/or external audits.
Responsibilities
- The Quality Engineer is responsible for developing and maintaining quality systems and providing quality system support for the division (e.g. commercialized products, new product development, manufacturing, and/or system compliance).
- Provides Quality System Body of Knowledge support to Division and organization.
- Implements and conducts data analysis, systems evaluation, and product assessment to ensure finished products meet standards and specifications; implement and drive changes where needed.
- Works with product development and production engineers during product development process to ensure quality deliverables (FMEA, Control Plans, Risk Management) are in place prior to Design Transfer phase gate.
- Ensures compliance with ISO 13485 & 21CFR 820 Quality System Regulations by providing support for interpretation of regulations, performing gap analysis and lead activities to implement improvements.
- Analyzes quality audit findings and recommends modifications in products or standards. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvements.
- As appropriate, participate in or lead teams in supporting quality disciplines, decisions, and practices (e.g., represents the Quality System function as a
Requirements
- Minimum of 2 years technical experience.
Nice to have
- Masters Degree preferred.
- Two - Five years technical experience.
- Previous Quality experience and demonstrated use of Quality Tools/methodologies.
- Detailed knowledge of FDA, GMP, and ISO 13485.
- Solid communication and interpersonal skills.
- Advanced computer skills, including gap analysis and report writing skills.
- Six Sigma certification preferred.
- ASQ CQE, CQA certification preferred.
Skills
- Abbott is a global healthcare leader that helps people live more fully at all stages of life.
- Our 115,000 colleagues serve people in more than 160 countries.
Compensation
- The base pay for this position is
Benefits
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with a high employer contribution.
- Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
Company info
- 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.
Equal opportunity
- 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
This listing is sourced directly from Abbott's careers page and normalized into a canonical job model.