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
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