Sr Quality Engineer

3 weeks ago

Northridge, United States LanceSoft Full time

Must Have:
2-5 Years Experience in Quality with BS in Engineering

Nice 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 Investigation

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

Education Required: Bachelors 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
Work Location:
Do they need to be local to any MDT office and if so where? On-site in Northridge preferred, open to remote or hybrid

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 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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