6 days old

Senior CAPA Engineer

Abbott
Sylmar, CA 91342

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.

Responsible for implementing and progressively improving the CAPA process and electronic system within the Quality Management System at Abbott. Reports to the Regulatory Compliance Manager for the business unit.

MAIN RESPONSIBILITIES

  • Communicate confidently and effectively with all levels of management, peers, and key stakeholders, including timely escalation of quality issues.
  • Accountable for leadership and oversight of the CAPA system, and associated deliverables.
  • Provide guidance, insight and training to the team and the wider business around CAPA process, quality standards, and regulatory requirements.
  • Lead and/or contribute to continuous improvement initiatives and projects.
  • Provide subject matter expertise during audits and inspections.
  • Represent CAPA QA in cross functional meetings (site and division).
  • High proficiency leading meetings and communications for QA system information, concerns, and updates.
  • Lead, develop, and mentor others with QA data analysis, trending, and reporting.  High proficiency with reporting and publishing weekly, monthly, and quarterly metrics.
  • Adept at staying current with organizational and industry information and routinely mentors/leads other members of the organization on quality assurance practices.
  • Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

    QUALIFICATIONS

    • Bachelors Degree Perferrably in Engineering, Technical Field, Life Science or closely related discipline or an equivalent combination of education and work experience.
    • Masters Degree Preferred.

      Experience/Background

      • Minimum 6 years in Quality or related field experience.
      • Previous CAPA and/or Quality Assurance/engineering experience and demonstrated use of quality tools/methodologies.
      • Prior medical device experience preferred.
      • Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016.
      • Solid communication and interpersonal skills.
      • Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
      • Advanced computer skills, including statistical/data analysis and report writing skills.
      • 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.
      • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
      • Multitasks, prioritizes and meets deadlines in timely manner.
      • Strong organizational and follow-up skills, as well as attention to detail.

        Division: CRM Cardiac Rhythm Management
        Travel: Yes, 5 % 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)

Categories

Posted: 2020-03-23 Expires: 2020-04-22

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Senior CAPA Engineer

Abbott
Sylmar, CA 91342

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