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Senior Development Quality Engineer

Company: Abbott Laboratories
Location: Santa Clara
Posted on: May 11, 2022

Job Description:

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 Development Quality EngineerSTRUCTURAL HEARTOur 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.Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. - We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.WHAT YOU'LL DOPrimary Duties and Responsibilities:

  • Lead on-time completion of Design Control deliverables
  • Lead Risk Management activities, including analyzing field data to support new product development, and supporting Failure Mode Effects Analysis
  • Complete Document Change Request Reviews in a timely and objective manner
  • Ensure Device History File (DHF) content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating and resolving gaps
  • Participates in Corrective Action/Preventive Action (CAPA) and Nonconforming Reports (NCR) processes including the investigation of failures or deviations, as required. Develop and lead other team members.
  • Create and ensure on-time execution of Quality Plans for internal development, OEM-based, and design change projectsSupport Duties:
    • Support Design Verification and Validation planning and execution, including study planning, test method and protocol review, active cross-functional root-cause analysis investigation and resolution activities
    • Support design test and inspection method development, and lead method validation activities
    • Support manufacturing process development and qualification for new product development and product changes
    • Supports R&D product builds for bench testing, animal lab, and clinical activities.
    • Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements
    • Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications
    • Support the development and review of biocompatibility and sterilization validations
    • Support internal and external audit responses and on-time product re-certificationsOther Duties:
      • Additional duties may be identified by functional management based on the current project/business objectives.
      • Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirementsEDUCATION AND EXPERIENCE YOU'LL BRINGRequired Qualifications:
        • Bachelor's degree within an Engineering field or related science-based discipline
        • 5+ years of experience in quality engineering
        • Quality Engineering experience and demonstrated use of Quality tools/methodologies
        • Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization -
        • Ability to work in a highly matrixed and geographically diverse business environment.
        • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
        • Ability to leverage and/or engage others to accomplish projects.
        • Multitasks, prioritizes and meets deadlines in timely manner.
        • Strong organizational and follow-up skills, as well as attention to detail.
        • Ability to travel approximately 10%, including internationally.Preferred Qualifications:
          • Advanced degree in a technical field
          • Medical device experience, specifically with single use intravascular catheters, implant delivery systems, valves and /or implantable devices
          • Prior experience in the development of early-stage medical device technologies
          • Experience working in a broader enterprise/cross-division business unit model
          • Prior experience working with any or all of the following: ISO 13485 Medical Devices - Quality Management System21 CFR Part 820 FDA Quality System Regulations ISO 14971 Medical Devices - Application of Risk Management EU MDR MD SAP Good Manufacturing Practices And Good Documentation PracticesWHAT 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 communitiesLearn more about our benefits that add real value to your life to help you live fully: -Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future.Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

Keywords: Abbott Laboratories, Santa Clara , Senior Development Quality Engineer, Engineering , Santa Clara, California

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