Job Title: Senior Quality EngineerCompany: Lead Medical Device Client Location: Northridge, CA > Remote or Hybrid acceptable Hiring Manager's Top Needs:
Experience creating and updating risk management documentation
- Looking for a Quality engineer who has experience supporting products in the Post-Market environment.
- Individual will be responsible for updating and maintaining risk management documentation and completing risk based decisions around product holds.
- The individual will work collaboratively with Supplier Quality and Manufacturing Quality as well as other stakeholders to evaluate product form, fit and function impact for on-market product.
- Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
- Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
- Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
- Education Required: Bachelors' Degree in Engineering, Science or Technical Field
- Years' Experience Required: 4+ years