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Sr Risk Management Specialist

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 109,000 colleagues serve people in more than 160 countries.

**About Abbott**

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.

The position of **Risk Management Specialist** is within our Infectious Disease Developed Markets business unit located at Scarborough, Maine. In this role you will actively participate in risk management activities according to ISO 14971, ensuring product and process conformance to FDA and ISO 13485 standards. This position will create, review and maintain risk management files. The position will lead cross functional teams in the creation and maintenance of risk analysis documents. This role requires strong communication, interpersonal and organizational skills, and a solid understanding of the application of FDA, ISO 13485, and ISO 14971 standards.


+ Represent the Quality function to provide design assurance support in the design and development of medical device products and facilitate the application of design controls and risk management.

+ Providing training and guidance to other Design Quality Engineers and Quality Assurance professionals on new product development and change processes.

+ Act as a reviewer and approver of validation methods and protocols, test methods, statistical analysis methods and specification development.

+ Review new and modified product designs for quality. Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation and other global regulations.

+ Act as a key contributor to development and validation plans and processes.

+ Act as a key team member in establishing, communicating and mitigating risks.

+ Ensure successful transfer of new products to manufacturing.

+ Review design history files and technical files for conformance to applicable requirements.

+ Support the continuous improvement to the Quality Management System, with a specialty focus on design controls and associated processes.

+ Identify and propose remediation for existing and potential quality issues; act as project team quality solution provider to maintain compliance.

+ Provides leadership in all areas of the Quality System, including but not limited to design controls, risk management, etc.

+ Provides leadership in the understanding of FDA and applicable non-US regulations pertaining to medical or pharmaceutical manufacturing, including hardware, software, and bioassay systems.



+ Bachelors’ degree (B.S.) in a Science related field, or equivalent combination of education and experience

+ 5+ years related experience and/or training in a Quality and/or Development Position.

+ Significant experience in risk management throughout the product lifecycle, including a strong working knowledge of ISO 14971


+ Experience supporting ISO 13485 inspections and FDA inspections.

+ Working knowledge of quality techniques such as root cause analysis, 5 why’s, and Ishikawa diagrams.

+ Experience in a multi-site development environment.

+ Experience in compliance management within a rapid-growth, dynamic organization.


+ Communicates effectively at all levels within Quality as well as cross-functionally with departments such as R&D, Regulatory, Manufacturing, and Marketing

+ Excellent problem solving and decision-making skills.

+ Initiative to work towards goals with minimal supervision


At Abbott, you can have a good job that can grow into a great career. We offer:

+ **A fast-paced work environment** where your safety is our priority ( **Manufacturing roles only** )

+ Production areas that are **clean, well-lit and temperature-controlled** ( **Manufacturing roles only** )

+ **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.

Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

**An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.**

We provide reasonable accommodation to qualified individuals with disabilities.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email

Sr Risk Management Specialist

Full time
Scarborough, ME

Published on 03/15/2021

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