Quality Systems Analyst

AbbottTemecula, CA
$61,300 - $122,700Onsite

About The Position

This position works out of our Temecula, CA location in the Abbott Vascular Division. Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.

Requirements

  • Bachelors Degree or an equivalent combination of education and work experience.
  • Minimum 2-5+ years Related work experience with a good understanding of specified functional area.
  • Working technical knowledge and application of concepts, practices and procedures.
  • General understanding of business unit/group function.
  • Will perform this job in a quality system environment.
  • Failure to adequately perform tasks can result in noncompliance with governmental regulations.
  • Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors.
  • Exercises judgment within defined procedures and practices to determine appropriate action.
  • Has a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.

Nice To Haves

  • Masters Degree - Preferred

Responsibilities

  • Provide support to QA activities for regulatory compliance (i.e. Management Review support, regulatory audits).
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
  • Responsible for independently updating audit data and metrics in a timely manner and in accordance with business standards.
  • Serve as a recognized technical expert in use of Audit Tracking tools.
  • Maintain, review, and update relevant documents and records to ensure compliance and accuracy.
  • Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  • Collect process data from different parts of the company for analysis and including in reporting of Quality metrics as required.
  • Exercises authority and judgment within defined limits to determine appropriate action.
  • Support internal and external team Sharepoint sites.
  • Assist and support inspection readiness and external audits, as requested.
  • Works with Regulatory Compliance Management to identify process improvement initiatives within the work area.
  • Plans, organizes, and prioritizes own daily work routine to meet established schedule.
  • Cultivates a internal network of resources to facilitate completion of tasks.
  • Support divisional quality and compliance initiatives, goals, and metrics.
  • May lead a project team of moderate scope.
  • Provides guidance to less experienced staff.
  • Perform other duties and projects as assigned.

Benefits

  • Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
  • An excellent retirement savings plan with high employer contribution
  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
  • 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
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