Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:
Career development with an international company where you can grow the career you dream of .
Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
An excellent retirement savings plan with 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.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
The Opportunity
This position works out of our Sylmar, CA location in the Cardiac Rhythm Management division.
As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
Development Quality Engineer I assures products, processes, and quality records conform to quality standards and establishes compliance with the quality system. Responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient safety and meeting business needs.
Lead on-time completion of Design Control Deliverables.
Create and ensure on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects.
Accountable for Design Verification and Validation planning and execution, including active cross-functional root-cause analysis investigation and resolution activities.
Lead or support Risk Management activities, including analyzing field data to support new product development, supporting Failure Mode Effects Analysis, generation of risk management plans/reports, and completion of hazard analysis.
Support design test and inspection method development, and lead method validation activities.
Ensure Device History File (DHF) content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating and resolving gaps.
?Execute and provide on-time completion of Quality Assurance (QA) engineering deliverables.
Support decision making and oversight of the quality systems, including CAPA (Corrective and Preventive Action) systems.
Support key stakeholders with developing and maintaining QA procedures, forms, and systems.
Support QA system training.
Support product review and analysis for QA activities.
Maintain databases and record storage for QA systems.
Process QA requests, ensuring owners are assigned, and timely responses are provided in alignment with quality goals.
Participate in meetings and communications for QA system information, concerns, and updates.
Support QA data analysis, trending, and reporting. Publish weekly, monthly, and quarterly metrics.
Track manufacturing related complaints in alignment with SJM goals.
Seeks out information with direction and able support other members of the organization on QA practices.
Support Global CAPA team with training, CAPA oversight, and CAPA deliverables.
Support presentation of CAPA System to internal and external auditors. Support investigation and resolution of system non-conformances and concerns (defined during internal and external audits).
As appropriate, participates in the completion of risk assessment, as related to QA systems.
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.
Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
