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Abbott Senior Quality Engineer in San Diego, California

DO WORK THAT MATTERS

At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.

Abbott Rapid Diagnostics (formerly Alere) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies. The position of Senior Quality Engineer within our Toxicology Business Unit located at San Diego, CA . In this role, you will be responsible for Supplier Quality Engineering activities that address supplier management, product/material changes, product/material quality issues, and compliance issues. You will partner with operations and materials management for process improvement and continuous improvement initiatives, while having an opportunity to be involved in the development of new products to support supplier related design control activities including but not limited to supplier selection and qualification, component qualification, contract development and materials design transfer.

RESPONSIBILITIES:

  • Maintain supplier quality management system.

  • Perform supplier qualification audits, monitor supplier performance, provide information for supplier program metrics and periodic reports, and assist in management of the supplier corrective action system.

  • Maintains the Supplier Audit Schedule and ensures compliance with this schedule.

  • Analyzes supplier failure analysis, assisting with root cause determination, and assigning corrective actions to contribute to supplier process and product improvements.

  • Support multiple projects, balancing priorities and resources to meet project and management expectations.

  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.

  • Demonstrates good judgment in selecting methods and techniques for obtaining solutions.

  • Support the QI (nonconformance) and CAPA processes by performing investigations and root cause analysis and determining action plans and driving the actions to closure.

  • Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.

BASIC QUALIFICATIONS:

  • BS/BA degree in Engineering, Biotechnology, or equivalent in related field or equivalent experience with relevant certifications.

  • Minimum of 5 years’ experience in a quality role within the medical device or other highly regulated industry with 3-5 years of progressively responsible positions.

  • Minimum of 2 years hands-on supplier management experience in creating, maintaining, and updating supplier file components such as supplier contracts, qualification plans and reports, supplier questionnaires, etc.

  • Minimum of 2 years hands-on experience completing supplier audits and all affiliated tasks as lead auditor according to ISO 9001 or 13485, including audit report generation, SCAR management and closure, etc.

  • Experience in manufacturing/quality engineering experience (design controls/change control, process validation, on market engineering support and risk management) in a regulated environment desired.

  • Experience reviewing and approving Device Master Record (DMR) documents required.

PREFERRED QUALIFICATIONS:

  • Direct work experience in IVD or medical device/biotech or regulated manufacturing environment.

  • Process, QMS or Supplier auditing experience desired.

  • Experience with reagent, ELISA, HEIA manufacturing desired.

  • Lean Six Sigma (Black or Green Belt), Certified Quality Engineer, Certified Quality Auditor desired.

  • Knowledge of IVDR in EU, FDA QSRs, ISO 13485:2016, ISO 14971:2012 standards and HACCP, GMP, GLP and GDP requirements.

  • Knowledge of computers and software programs including Word, Excel, Access, Visio, MS Project, Minitab, PowerPoint, and Agile.

  • Experience with root cause analysis, failure mode analysis, verification, and validation.

  • Statistical tools including basic statistical inference, graphical methods, regression.

  • Knowledge of Quality System Regulations.

  • ASQ QE, ASQ CQA or CBA

  • Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor.

COMPETENCIES:

  • Analytical Skills (e.g. statistical, risk analysis, engineering analysis)

  • Team player

  • Interpersonal Skills

  • Drives for results

  • High level of attention to detail

  • Collaboration

About Abbott

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

An equal opportunity employer, Abbott welcomes andencourages diversity in our workforce. We provide reasonable accommodation toqualified individuals with disabilities. To request accommodation, please sendan email to MyRecruiter@alere.com

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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