Job Description

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.
• 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 high employer contribution.
• Tuition reimbursement, the student debt program and 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.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Santa Clara, CA, location in the Structural Heart division. Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

We are seeking a skilled Quality Engineer to assume primary responsibilities in test method validation. The ideal candidate will possess extensive knowledge in this area. Additionally, the QE may be tasked with equipment/tooling logistics responsibilities, contingent upon their expertise and organizational needs. The role also encompasses supporting receiving inspections, in-house manufacturing inspections, and managing nonconformance reports.

Core Job Responsibilities

• Plans for, executes and documents test method validations for receiving inspection methods and in-house manufacturing inspection methods.
• Supports receiving inspection and/or in-house manufacturing as applicable and necessary.
• Supports equipment/tooling asset managements, such as the handling of new creations, deactivations, calibration or preventative maintenance issues, and/or documentation of loss assessments.
• Supports or owns executions of non-conformance reports, which may include the preparation of associated metrics.
• Liaises with other Abbott sites to ensure compliance to quality system.
• Works within a GMP environment and documents results per GDP standards. Holds R&D, and operations accountable to GMP and GDP requirements.
• Supports sterilization activities and documentation (submission forms, LAL, Bioburden, etc.)
• Leads cross-functional teams to achieve consensus for deliverables associated with quality issues.
• Maintains inspection procedures for the inspection of incoming materials, in-process materials and finished goods. Select appropriate inspection, test and measurement equipment, fixtures, and gauges.
• Ensures compliance with all procedures and all applicable regulatory agency requirements.
• Identifies continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for improvement and optimization.
• Works with engineers and manufacturing to transfer technical information into easy to understand written form, as well as take a hands-on approach to learning and documenting the processes.
• Other duties as assigned.

Qualifications

• Bachelor's degree in Engineering or equivalent or a related field.
• 2-3 years (+) experience in Quality Assurance/Quality Engineering from medical device or pharmaceutical industry.
• Sufficient knowledge in test method validations & statistical analyses.
• Regulations experience in any: 21 CFR 820, FDA, 13485, 14971.
• Proven experience in relevant areas of Quality, Regulatory or Engineering, preferably within a medical device environment
• Advanced knowledge of relevant regulations is required to act as a resource for colleagues.
• Must be able to take accountability with excellent follow up and follow through.
• Strong written and verbal communication skills and ability to collaborate effectively.
• Capable of producing results working unsupervised under own initiative.
• Must be an effective team player with the ability to mentor, lead and problem solve to provide solutions to the business.
• Confident and open personality who is able to communicate effectively, both written and orally with people at all levels.
• Experience with equipment/tooling management logistics a plus.
• Experience with external/internal audits and EtO Sterilization a plus.
• Ability to work efficiently under tight timelines.

Job Family: Operations Quality

Division: SH Structural Heart

Location: United States > Santa Clara : Building A - SC

Additional Locations:

Work Shift: Standard

Travel: No

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.