Senior Quality Engineer
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 113,000 colleagues serve people in more than 160 countries.
Senior Quality Engineer
Santa Clara, CA
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 aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.
WHAT YOU’LL DO
Manages & monitor site NCR/CAPA including reporting requirements, provide detailed updates and information in support of quality, also liaising with other Abbott sites to ensure compliance to quality system.
Perform or review manufacturing non-conformances reports, CAPA, failure investigations and audit findings to report manufacturing related issues that may impact quality and recommend courses of corrective action.
Prepare metrics for NCRs, CAPA, suppliers’ performance and analyze process data and trends and drives optimization and improvement. Perform and report line defects trend analysis.
Interface with suppliers to ensure product meets specifications.
Audit the work of others through review of labeling, documentation (MPI’s, LHR’s, etc.) and lot history records and provide final quality approval.
Work within a GMP environment and document results per GDP standards. Holds R&D, and operations accountable to GMP and GDP requirements.
Support sterilization activities and documentation (submission forms, LAL, Bioburden, etc.)
Ensure training requirements for internal and external staff are established and maintained in a training matrix.
Conduct and assign training initially for new staff and follow up on training due to changes or re-review.
Leads cross-functional teams to achieve consensus for deliverables associated with quality issues.
Maintain inspection procedures for the inspection of incoming materials, in-process materials and finished goods. Select appropriate inspection, test and measurement equipment, fixtures, and gauges.
Ensure 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.
Work 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.
EDUCATION AND EXPERIENCE YOU’LL BRING
Bachelor’s degree in Engineering or equivalent or a related field.
6 years (+) experience in Quality Assurance/Quality Engineering from medical device or pharmaceutical industry.
Regulations experience in any: 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.
Ability to work efficiently under tight timelines.
Experience with external/internal audits and EtO Sterilization a plus.
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 onboarding 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
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