Senior Quality Assurance Engineer

3 days ago

Santa Clara, California, United States Abbott Laboratories Full time
About Abbott Laboratories

Abbott Laboratories 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.

Job Summary

We are seeking a highly skilled Senior Quality Engineer to join our team in the Structural Heart division at our Santa Clara, CA location. As a Senior Quality Engineer, you will be responsible for managing and monitoring site NCR/CAPA, including reporting requirements, and providing detailed updates and information in support of quality. You will also liaise with other Abbott sites to ensure compliance to quality system.

Key Responsibilities
  • Manage and monitor site NCR/CAPA, including reporting requirements
  • Provide detailed updates and information in support of quality
  • Liaise 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
  • 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
Requirements
  • 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
  • Experience with external/internal audits and EtO Sterilization a plus
About the Opportunity

This position offers a unique opportunity to work in a dynamic and innovative environment, where you will have the chance to make a real impact on the quality of our products and services. As a Senior Quality Engineer, you will be part of a cross-functional team that is dedicated to delivering high-quality products and services to our customers.

What We Offer

At Abbott Laboratories, we offer a competitive salary and benefits package, as well as opportunities for professional growth and development. We are committed to creating a diverse and inclusive work environment, where everyone has the opportunity to succeed.

How to Apply

If you are a motivated and experienced Quality Engineer looking for a new challenge, please submit your application, including your resume and a cover letter, to our website. We look forward to hearing from you

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