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 114,000 colleagues serve people in more than 160 countries.
Works closely with cross functional teams to establish and ensure compliance and quality for product related risk management documentation.
Perform risk assessments and evaluations for products that conform to established standards and agency regulations.
- Perform risk evaluations associated with post market data, give guidance to risk evaluations for product development.
- Perform Health Hazard Evaluations
- Works cross functionally with development / manufacturing / quality / regulatory / clinical to establish product risk documentation.
- Demonstrates compliance with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, and contractors.
- Proactive in finding quality improvements related to Risk Management processes.
Bachelors Degree ( 16 years)
In Engineering or related field.
an equivalent combination of education and work experience
Minimum 2 years
Preferably in an Implantable Medical device, regulatory environment or pharmaceutical manufacturing. Preferred understanding of complaint management and Health Hazard Assessments for on-market (distributed) product.
Credentials of a Certified Quality Engineer are a plus.
Knowledge of GMP, ISO, FDA regulations, and quality systems auditing is desired.
Must possess good communication and analytical skills.
Ability to work under deadlines.
Strong project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
Demonstrates technical leadership within the department and outside the department.
Ability to work in a highly matrixed and geographically diverse business environment.
Ability to leverage and / or engage others to accomplish projects.
Strong organizational and follow-up skills, as well as attention to detail.
Ability to travel, including internationally.
The base pay for this position is $65,900.00 $131,900.00. In specific locations, the pay range may vary from the range posted.
Quality Engineer II, Risk Management
Works closely with cross functional teams to establish and ensure compliance and quality for product related risk management documentation. Proactive in finding quality improvements related to Risk Management processes. Perform risk evaluations associated with post market data, give guidance to risk...
Quality Engineer Ii, Risk Management
Works closely with cross functional teams to establish and ensure compliance and quality for product related risk management documentation. Proactive in finding quality improvements related to Risk Management processes. Perform risk evaluations associated with post market data, give guidance to risk...
Quality Engineer II, Risk Management
Works closely with cross functional teams to establish and ensure compliance and quality for product related risk management documentation. Proactive in finding quality improvements related to Risk Management processes. Perform risk evaluations associated with post market data, give guidance to risk...
Foundry Quality Engineer
Depending on location, this position may be responsible for the execution and maintenance of the ISO 9000, 9001, 14001 and/or other applicable standards that may apply to the relevant roles and responsibilities within the Quality Management System and Environmental Management System. Utilize Quality...
Senior Silicon Photonics Quality and Reliability Engineer
Depending on location, this position may be responsible for the execution and maintenance of the ISO 9000, 9001, 14001 and/or other applicable standards that may apply to the relevant roles and responsibilities within the Quality Management System and Environmental Management System. Lead industry-l...
Data Engineer, Operations Quality Assurance (P-4148)
Genomics is seeking a highly skilled and motivated Data Engineer to join our Quality Assurance team within our Operations division. The ideal candidate will have a strong background in data engineering, a passion for life sciences, and the ability to design, develop, and maintain robust data pipelin...
Air Quality Engineer/Scientist (Environmental Compliance Specialist)
Yorke Engineering, LLC has assisted over 1,900 client organizations with their Air Quality and Environmental Compliance, Engineering, and Permitting needs. Chemical Engineering, Environmental Engineering, or Mechanical Engineering, or other relevant technical degrees from an accredited college (mini...
Global Facilities Project Manager - Multi Greenfield US/EMEA Sites
Global Facilities Project Manager. Facilities Project Manager - Job Overview. Seeking an experienced Facilities Project Manager with a deep understanding of U. Develop and manage comprehensive project plans, including timelines, budgets, and resource allocation, to ensure timely and cost-effective p...
Program Manager - Vacaville, CA
Following our agreement with Roche to acquire the Vacaville manufacturing facility, we are now looking to recruit a Senior Program Manager for the Vacaville site!. Managing complex projects requires a unique set of skills that are consolidated into the role of Program Manager (PM). You will therefor...
QA Automation Engineer
Job Title: QA Automation Engineer. ...