Quality Engineer With Medical Device - Los Angeles, United States - MasterCompliance LLC

Description

HM's top needs:
Post-Market Quality Engineering experience
Highly prefer product quality support vs manufacturing, testing or supplier quality experience
Extended Core Team experience for product launch / later stage product development

Education Required:
Bachelor's in engineering, science or technology discipline
Years' Experience Required: 4-10 years preferred.
Will the contractor be working 40 hours a week? If not, weekly estimate? 40 hours weekly

Responsibilities include the following but not limited to:
Develops, modifies, and maintains quality system procedures.
Supports internal or external audit activities where needed.
Supports nonconformance investigations and dispositions.
Collaborates 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 qualifications.

Understand 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 regulations.
Driving clarity and consistency in documentation.
Leading CAPA projects and assisting with 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 engineering.

Required 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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