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Sr. Quality Engineer, Risk Management

Abbott Laboratories

This is a Contract position in Los Angeles, CA posted May 14, 2022.

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.


Quality Engineer, Risk Management Menlo Park, CA Our 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.

WHAT YOULL DO We are recruiting for a Sr.

Quality Engineer, Risk Management professional to join our team located in Menlo Park, CA.

You would be the Subject Matter Expert (SME) responsible for developing and maintaining quality systems and/or quality subsystems and/or key process(es) pertaining to Risk Management while providing quality engineering support within new product development, manufacturing, or system/services support.

Responsibilities: Responsible for implementing and maintaining the effectiveness of the Risk Management Quality System element.

Interprets regulations and requirements to lead, coach, and mentor teams on Risk Management.

SME for domestic/international sites and affiliates regarding Risk Management Quality System element.

Estimates project levels of effort and resource requirements by working with appropriate staff to understand scope of effort.

Participate in or lead teams in supporting quality disciplines, decisions, and practices for risk management.

Directs project execution by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans.

Resolves project issues by working with team members, project customers, and others as appropriate.

Interfaces with management and cross functional teams on significant matters, often requiring the coordination of activity across organizational units.

Lead and implement various improvement methodologies as it pertains to Risk Management.

Mentor, coach and train new product development teams and sustaining engineering teams to create or maintain product risk assessments.

Mentor, coach, and train engineering staff to prepare Health Risk Assessments.

EDUCATION AND EXPERIENCE YOULL BRING Required Bachelors degree in Engineering or related technical field.

5 years experience working in a broader enterprise/cross-division business unit model preferred.

Ability to work in a highly matrixed and geographically diverse business environment.

Experience with risk management (ISO 14971).

Work within a team and as an individual contributor in a fast-paced, changing environment.

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.

Advanced computer skills, including statistical/data analysis and report writing skills.

Experience implementing various product and process improvement methodologies (e.g., Six Sigma and Lean Manufacturing).

Multitasks, prioritizes, and meets deadlines in timely manner.

Strong organizational and follow-up skills, as well as attention to detail.

Preferred Prior medical device experience preferred.

Experience working in a broader enterprise/cross-division business unit model preferred.

Knowledge of devices used for PTCA and PTA is desirable.

Knowledge of various tools and techniques for Risk Management is desirable.

Knowledge of IEC60601-1 or electrical safety is desirable.

WHAT 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 communities Learn 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.

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