Senior Product Quality Engineer

Pleasanton  ‐ Onsite
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Keywords

Description

Provide Quality Engineering support to manufacturing and product development teams. Helping to ensure development of highest quality new products.
Participates in the development and implementation of new products or product changes by creating product specifications, quality specifications, quality plans, risk analyses, FMEAs in conjunction with other product development team members.
Runs complex problem solving efforts with minimal oversight, and mentors others on best practices. e.g. DOE, Green Belt Certification. e.g. Leads/ coordinates RCA of failures using a structured approach.
Develops or participates in the development and establishment of quality system/subsystems.
Works within quality system with minimal oversight.
Leads cross functional projects and plans novel strategies with minimal direction. Considers options and mitigations in planning. Coordination of tasks, delegation and prioritization with no oversight. e.g. experienced with Gantt, Project or ProChain.
Mentors others in effective protocol and report writing. Delivers Right first Time reportse.g. Verification, Validations, line transfers
Correctly interprets and complies with Code of Federal Regulations for medical devices for area of work and mentors other in their application. Works at mitigating group of compliance issues. SME - Leading Post Audit follow up activities. e.g. Coordinating agency responses from Audit findings. Discusses CAPA or report with Auditor.
Compiles and presents data in clear concise formats. Presentation skills to upper level management required.
Creates Quality Tools & Training Materials by applying body of knowledge/expertise and communicating to respective teams.

Bachelor's degree plus 5-7 years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred.
Develop/Complete RAM/FMEAs and perform the appropriate analytical method(s) to develop strategies for product qualification verification and validation with minimal direction. Considers SQC techniques , periodic review etc.
Develops/ implements and improves test method strategies for a product/system.
Strong understanding of business unit function and cross group dependencies/relationships.
Ability to resolve problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors.
Start date
07/2014
From
Real Staffing
Published at
05.07.2014
Project ID:
737200
Contract type
Freelance
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