Senior Quality Assurance Engineer

Abbott Laboratories in Saint Paul, MN

  • Industry: Engineering - Biological And Biomedical Engineer
  • Type: Full Time
  • $108,290.00 - 164,710.00
position filled

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 103,000 colleagues serve people in more than 160 countries.

SENIOR QUALITY ASSURANCE 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 103,000 colleagues serve people in more than 160 countries.

A position of Senior Quality Assurance Engineer is open in the Structure Heart Division of Abbott, reporting to the Manager of Quality.

CORE JOB RESPONSIBILITIES

  • Own the nonconformance (NCR) process and appropriate documentation.
  • 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.
  • Maintain/publish the approved supplier list.
  • Support the equipment or tool calibration program.
  • Participate in external audits and in the execution of the internal audit plan.
  • Make recommendations for corrections and corrective actions.
  • Audit the work of others through review of labeling, documentation (MPI?s, LHR?s, etc.) and lot history records and provide final quality approval.
  • Support sterilization activities and documentation (submission forms, LAL, Bioburden, etc.)
  • Work within a GMP environment and document results per GDP standards. Holds R&D, and operations accountable to GMP and GDP requirements.
  • 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.?

QUALIFICATIONS

  • Bachelor?s degree in Engineering or equivalent or a related field.
  • Experience in relevant medical device regulatory requirements and standards (e.g. ISO, IEC, MDD, QSR, CMDR.)
  • Proven experience in relevant areas of Quality, Regulatory or Engineering, preferably within a medical device environment.
  • 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.?
  • Ability to work efficiently under tight timelines.

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Monitor supplier performance and report supplier quality trend data to upper management. 6 years of experience in Supplier quality related functions. Manage a staff of Supplier Quality Engineers to support...

  • JOB ID:

    30933100

    • LOCATION

      United States - Minnesota - St. Paul

    • DIVISION

      SH Structural Heart

      • TRAVEL

        Yes, 10 % of the Time

        • 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)

          • Our business encompasses many different functions and capabilities, which allows you to explore careers in various fields.?

            GROWTH PLANNING

            Growth Planning and Performance Excellence is an annual process through which you'll be able to have open career discussions with your manager to help you determine your own career path and future.

            TRAINING & NETWORKS

            We provide a wide range of classroom and e-learning courses to help you develop new skills and enhance your career.?

            WE'RE RECOGNIZED AROUND THE WORLD

            DOW JONES SUSTAINABILITY INDEX

            BEST CORPORATE CITIZENS

            FORTUNE CHANGE
            ???????THE WORLD

            FORTUNE'S MOST ADMIRED COMPANIES

            JOIN OUR TALENT COMMUNITY

            We will notify you about relevant positions, and keep you in mind whenever we have intresting opportunities. Come get them..

            Abbott welcomes and encourages diversity in our workforce including Minorities, Women, Individuals with Disabilities and Protected Veterans.

            We provide reasonable accommodation to qualified individuals with disabilities.

            Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.


            Associated topics: bio, bioinformatic, biomedical, biomedical engineer, biosynthetic, genetic, medical, msat, parenteral, pathogenesis

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