Vacancy expired!
Bachelor’s Degree in Engineering or Science with 4+ years of work experience in Quality and/or Software Development OR Master’s Degree in Engineering or Science with 2+ years of work experience in Quality and/or Software Development.• Experience working in a regulated industry (e.g., FDA-regulated).• As a Quality Core Team member, collaborate with cross-functional project team members as well as members of the QA extended team.• Demonstrate the ability and desire to work within a regulated medical device development environment, particularly based on the FDA Quality System Regulation and ISO 13485.• Ensure internal Design Control policies and procedures comply with regulations and external standards, including software regulations, risk management, and change control.• Identify and implement process improvements to increase efficiencies and product quality.• Lead and drive collaborative design and development of medical devices.• Participate in the development of requirements, software design, interface and test design.• Collaborate & develop SW FMEA to help drive good designs at early development stages.• Collaborate and develop system hazard analysis.• Ability to read software code and participate in detailed technical design and code reviews.• Lead and drive CAPA projects.• Collaborate effectively with the cross functional teams and other stakeholders.• Demonstrate excellent coding, design and test practices.• Understand the interdependencies of program work products and guide the teams in execution strategy and participating in development, review and approval of all program work products (e.g. plans, requirements, specifications, tests, test results, traceability, risk management documents, reports).• Interact and form constructive working relationships with all levels of leadership within Quality, Marketing, R&D, Systems Engineering and Operations.• Provide training and coaching to cross-functional peers in maintaining compliance to internal and external Quality requirements and regulations• Participate and support external regulatory audits and inspections.• Provide solutions to a wide range of difficult challenges. Work independently to determine and develop solutions that are imaginative, thorough, practicable, and consistent with organizational objectives.• Performs other related duties as assigned.
Vacancy expired!