Vacancy caducado!
Location: Thousand Oaks, CA Salary: Annual Salaried Position, Description: Our client is currently seeking a Principal Quality Engineer - Digital (722083) for Full Time Perm employment position, Contact Brian at or email
Principal Quality Engineer - Digital FocusRelevant Experience (in Yrs): Master's degree and 6 or more years of professional experience Program Management, Operational Excellence, Quality, R&D, Production in Medical Industry OR Bachelor's degree and 8 years of professional experience Program Management, Operational Excellence, Quality, R&D, Production in Medical IndustryTechnical/Functional Skills:As the Quality Engineering representative on cross-functional digital health product teams, employ quality principles and company's procedures including but not limited to the areas of good software engineering, medical device design control, Change Control and NC/CAPA, Risk Management, Human Factors Engineering, to ensure development of digital health product complies with regulations and standards while accommodating Agile software methodology. Train and educate key functional partners and management on medical device and digital health product requirements, standards and regulationsPlan and lead improvements to the SaMD quality processesProvide independent design review for other programsEnsure inspection readiness and maintain CE marks for existing software medical devicesConduct investigations, root cause analyses and risk assessmentsCollaborate cross-functionally and with Senior Management to drive improvements and provide backup support to other Quality focus areasWork in partnership with the DH&DQ Leadership to develop business plans that cultivate staff development and supports the direction of the business Benchmark with industry regarding quality and compliance models for software medical devices and digital health products. Excellent Analytic problem solving, Broad business planning, Cross-functional integration skillsMust possess strong communication skills both oral and written.Ability to communicate and coordinate with customers Personal computer skills: Power point presentations, e-mail, Microsoft Project ManagementDescription:Accountable to ensure quality and compliance associated with software medical devices, to develop, maintain, and continuously improve the software medical device and digital health product quality capability, to ensure compliance with procedures and regulatory expectations for existing and new software medical device and digital health product programs, and to develop and optimize programs that focus on maintaining regulatory and compliance requirements while using risk-based, scalable approaches. Key Responsibilities:As the Quality Engineering representative on cross-functional digital health product teams, employ quality principles and company's procedures including but not limited to the areas of good software engineering, medical device design control, Change Control and NC/CAPA, Risk Management, Human Factors Engineering, to ensure development of digital health product complies with regulations and standards while accommodating Agile software methodology. Train and educate key functional partners and management on medical device and digital health product requirements, standards and regulationsPlan and lead improvements to the SaMD quality processesProvide independent design review for other programsEnsure inspection readiness and maintain CE marks for existing software medical devicesConduct investigations, root cause analyses and risk assessmentsCollaborate cross-functionally and with Senior Management to drive improvements and provide backup support to other Quality focus areasWork in partnership with the DH&DQ Leadership to develop business plans that cultivate staff development and supports the direction of the business Benchmark with industry regarding quality and compliance models for software medical devices and digital health products AuthorityAssure that current regulatory trends are accommodated in the capabilityAdvise software medical device and digital health product teams as Quality representativeReview and approve medical device design control and post-commercial deliverables (internally and at times, externally)Interface with regulators and Notified BodiesReview and approve procedures and work instructionsGeneric Managerial Skills: N/AEducationBachelor's degree and 8 years of professional experience Program Management, Operational Excellence, Quality, R&D, ProductionBrian K. Kubiak, Sr. Technical Recruiter, The Judge Group Direct Dial: | Email: linkedin.com/in/brian-k-kubiak-3593983 Click to learn more about Judge's Technology , Talent & Learning Solutions people powered business solutions Contact: This job and many more are available through The Judge Group. Find us on the web at www.judge.comVacancy caducado!