Abbott

Senior Quality Engineer – Risk Management

Abbott

full-time

Posted on:

Location Type: Office

Location: Pleasanton • California • 🇺🇸 United States

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Salary

💰 $86,700 - $173,300 per year

Job Level

Senior

About the role

  • Develop and maintain quality systems and/or key process(es) pertaining to Risk Management while providing quality engineering support within new product development, manufacturing, system/services support and/or post market support.
  • Implement and maintain the effectiveness of the Risk Management Quality System element.
  • Interpret regulations and requirements to lead, coach, and mentor teams on Risk Management.
  • Act as SME for domestic/international sites and affiliates regarding Risk Management Quality System element.
  • Work cross functionally with development, manufacturing, quality, regulatory, and clinical teams to establish product risk documentation.
  • Mentor, coach and train new product development teams and sustaining engineering teams to create or maintain product risk assessments.
  • Perform Health Hazard and Regulatory Risk Evaluations.

Requirements

  • Bachelor's degree in engineering or Technical Field
  • 5+ years in related work experience or an equivalent combination of education and work experience
  • Risk management (ISO 14971)
  • Experience working in a broader enterprise/cross-division business unit model (Preferred)
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment (Preferred)
  • Knowledge of IEC60601-1 or electrical safety (Preferred)
  • Travel: Yes, 5% of the Time
Benefits
  • Career development with an international company where you can grow the career you dream of.
  • 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 a 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.
  • Health and wellness benefits (referenced at www.abbottbenefits.com).

ATS Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
Risk ManagementQuality SystemsHealth Hazard EvaluationsRegulatory Risk EvaluationsISO 14971IEC 60601-1Product Risk AssessmentsQuality EngineeringNew Product DevelopmentManufacturing Support
Soft skills
MentoringCoachingTeam CollaborationLeadershipCommunicationAdaptabilityTrainingCross-Functional CollaborationIndividual ContributionProblem Solving
Certifications
Bachelor's Degree in EngineeringTechnical Field Degree
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