NPI Senior Supplier Quality Engineer
A biomedical manufacturing company is seeking a Senior NPI (New Product Introduction) Quality Engineer to work with Instrument NPI Quality Engineering team and Global Supply Chain to provide quality system regulation and supplier selection guidance. Ensure product compliance with QSR and QMS. Ensures incoming parts that are internally produced meet the quality standards and systems required.
- Work with Instrument NPI Quality Engineering and Supply Chain to help scope and attend technical assessments and design reviews by providing quality system regulation and supplier selection guidance
- Assist project(s) with direction on sound design control strategy for suppliers during product development ensuring compliance with QSR and QMS, supporting a product release that is safe and effective, sustainable in the field, and able to withstand an external audit
- Review Finished Good Supplier test plans for appropriate size/scope to meet product intended use, claims, customer and marketing requirements, functional and regulatory requirements
- Lead and review Supplier test protocols and reports to ensure design outputs will or have met input requirements, acceptance criteria was appropriately defined and has been met and any deviations have appropriate rationale and are documented correctly
- Help drive the scope and attend technical assessments and design reviews by providing quality system regulation and supplier qualification guidance
- Attend and guide risk assessments with suppliers, ensuring effective hazard identification, appropriate risk controls identification, and appropriate documentation of risk assessments
- Lead and address any supplier related corrective actions and improvements throughout Product development stage.
- Provide Supplier Quality Engineering support including Control Plan development, Test Method Validations, Supplier Audits and Qualification activities, Inspection Plans, First Articles, and Nonconforming Product.
- Ability to independently lead projects as core team Quality lead for NPI Quality or Supplier Quality projects.
Bachelor’s Degree in mechanical engineering, electrical engineering, industrial engineering or related discipline and a minimum of five (5) years related experience OR
Master’s Degree in mechanical engineering, electrical engineering, industrial engineering or related discipline and a minimum of three (3) years related experience
Knowledge and Skills
Strong background and experience in a Supplier Quality Engineering role for Instrumentation
Strong background and experience in a Quality Engineering role for Instrumentation hardware.
Experience in the application of production and process controls including process validation, process control plans and statistical process control utilizing best practice and innovation.
Experience in utilization and application of Statistical methods for computing and analyzing data, and driving measures and actions for improvement
Experience in initiating and driving Manufacturing Process and Quality System improvements working in a Team Environment utilizing best practices and innovation
Experience developing business processes and quality systems enhancements (product design through manufacturing) in a mature industry that has stringent quality regulations.
Experience in leading quality system audits.
Ability to work in an office environment, audit manufacturing sites with travel to supplier sites approximately 10 percent of the time.
For more than forty years, Richmar Associates has connected talented job seekers with Silicon Valley businesses from start-ups to Fortune 500. We specialize in the temporary and direct placement services business. Based in the Silicon Valley, Richmar offers staffing solutions that include temporary, temp-to-hire, payroll service, vendor management and direct placement services to clients in the High-Tech Industry.
Richmar is an Equal Opportunity Employer.