Sr Quality Engineer

2 weeks ago

Northridge, United States LanceSoft Full time

Must Have:2-5 Years Experience in Quality with BS in EngineeringNice to Have:Experience in regulated industry and post-market medical device product support, familiarity with quality system requirements and medical device regulations.Experience working with CAPA and Complaint InvestigationHM's top needs:1. Post-Market Quality Engineering experience2. Highly prefer product quality support vs manufacturing, testing or supplier quality experience3. Extended Core Team experience for product launch / later stage product developmentEducation Required: Bachelors in engineering, science or technology disciplineYears' Experience Required: 4-10 years preferredWill the contractor be working 40 hours a week? If not, weekly estimate? 40 hours weeklyWork Location:Do they need to be local to any MDT office and if so where? On-site in Northridge preferred, open to remote or hybridResponsibilities include the following but not limited to:Develops, modifies and maintains quality system proceduresSupports internal or external audit activities where neededSupports nonconformance investigations and dispositionsCollaborates with operations, manufacturing, engineering and regulatory functions to ensure quality standards are in place.Supports new product introduction activities with product design transfer efforts, reviewing and approving plans and reports and supporting design qualificationsUnderstand complex issues and consult with various functions to conduct meaningful analyses.Training and coaching cross-functional peers on maintaining compliance to internal and external Quality requirements and regulationsDriving clarity and consistency in documentation.Leading CAPA projects and assisting post market analysis.Work under consultative direction toward predetermined long-range goals and objectives. Determine and pursue courses of action necessary to obtain desired results through consultation and agreement with others rather than by formal review of superior.Participate on extended Quality core team for new products and serves as voice of post-market quality engineeringRequired Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

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