PHYSICAL AND MENTAL REQUIREMENTS, WORKING CONDITIONS

• Learn new tasks, remember processes, maintain focus, complete tasks independently, make timely decisions in the context of a workflow, ability to communicate with others, ability to complete tasks in situations that have a speed or productivity quota.
• Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. This position requires close visual acuity to perform activities such as preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading.

ABOUT THE ROLE

Foresight is seeking an Associate Software Design Quality Engineer to support the Quality Assurance team. The Associate Software Design Quality Engineer is part of software quality engineering team providing quality and compliance support to ensure products are developed per FDA 21 CFR Part 820, ISO 13485:2016, ISO:14971, and other applicable regulations. The ideal candidate has introductory level experience in applying software quality practices to regulated medical device products or introductory experience applying software development life cycle methodologies in a regulated environment. This role supports the completion of software risk analysis, assists with conducting root cause analysis for non-conformances, deviations, Corrective and Preventive Actions (CAPA), and supports internal and external audits.

WHAT YOU WILL DO

• Support the review of software deliverables for the Design History File for product launches for compliance with Quality System and Design Controls principles.
• Review software product requirements to ensure acceptance criteria and internal procedures have been met and are compliant with applicable regulations.
• Collaborate with the cross-functional teams to lead risk management activities and establish risk documentation per ISO 14971 for new product/service development projects to support regulatory submissions.
• Assist in the completion and maintenance of software risk files and other supporting deliverables.
• Support product development team with quality assessments of design changes, non-conformances, and impact on design history files and risk management files, as assigned by management.
• Assist with software opportunities for continuous improvement projects and Corrective & Preventative Action(s) (CAPA).
• Participate in FDA inspections, Notified Body audits, and other internal and external audits.