Quality Assurance Specialist

Quality Assurance Specialist




Quality Assurance Specialist

Details of the offer

At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.
We have an exciting opportunity for a Quality Assurance Specialist within our Abbott Rapid Diagnostics business located at Scarborough, Maine. In this role, you will actively participate in the creation of design control procedures that ensure product and process conformance to FDA and ISO 13485 standards.

You will also actively participate in updating Design History Files for on-market products and creating Design History Files for new products in development.
Abbott Rapid Diagnostics (formerly Alere) 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.
Collaborate with design control subject matter experts, cross-functional teams, and consultants to create new and modify existing design control SOPs.
Facilitate the application of design controls to both on-market products and new products in development.
Create, review and maintain design input/design output trace matrices.
Review product designs for quality and compliance. Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation and other global regulations.
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.

Excellent verbal and written communication skills.

Bachelors? degree (B.S.) in a Science or engineering related field, or equivalent combination of education and experience.
1-3 years related experience and/or training in a Quality and/or Product Development Position.
Experience in an FDA-regulated environment.
Manufacturing experience in medical device, pharma, or food required.
Proficiency with Microsoft Office Suite.
Remediation experience a plus.
Working knowledge of design controls throughout the product lifecycle.
Working knowledge of 21 CFR 820 and ISO 13485.
International experience desired.

Source: Jobsxl


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