Staff Orange is looking for Quality Engineer
Title: Quality Engineer
Location: Santa Rosa, CA “LOCAL ONLY”
Duration : 7 Months
Job Duties :
-Completes Design History File documentation
-Creates and delivers presentations throughout the organization
-Design of Experiments (DOE) and Statistical Process Control (SPC)
-Determines manufacturing operation requirements and process parameters
-Develops advanced manufacturing systems and processes
-Develops and implements strategic plans
-Develops plans to evaluate process repeatability and stability
-Develops product and process improvements
-Participates in internal supplier audits
-Participates in procedure writing and review
-Performs process and equipment validations
-Provides technical support to other engineers
-Specifies and implements process lay-outs
-Supports manufacturing, development, and implementation processes
-Utilizes FMEA within process development
-Ensures compliance with GMP's
-Generates documentation for engineering protocols and reports
-Implements quality system improvements
-Writes engineering and manufacturing specifications
Skill Sets:
Required:
Desired:
Certifications/ Engineering:
Design Controls, DHF, and Engineering Documentation
QS, 21CFR - GMP/QSR, 29/40CFR, title 8, and NRC Compliance
Education Level:
Undergraduate Degree
High School Diploma or Equivalent
Industry Experience:
1 - 3 Years
Oral Communication:
Excellent
Facilitation Skills
Travel:
10-25% Travel
Written Communication:
Excellent
Legible Handwriting
Certifications/ Engineering:
ASQC
ISO 9000, 9001, 9002 Certification Preparation
Education Level:
Quality or Reliability Certification
Industry Experience:
3 - 5 Years
Greater than 5 Years
Greater than 10 Years
Supply Chain Management Packages:
SAP
Agile
eMatrix
Position Description
-As a Contract Component Engineer you will have the responsibility for partnering with Design Engineering and Technical Sourcing (TSS) to identify, develop, qualify, document and release cost effective components/materials from a variety of commodities for use in Client CardioVascular products.
-In this area of new product development you will be required to drive multiple aspects of component/material development and approval with suppliers as a member of a cross-functional team.
Position Responsibilities
-Provide project team support across multiple commodities (e.g. plastics, electronics, metals, chemicals, fabrics, sutures, OEM) as the resident component/material expert.
-Partner with Technical Sourcing to locate, evaluate, and approve new potential component/material suppliers for active projects.
-Perform process and component/material development work with suppliers to deliver on-time components/materials that meet downstream manufacturing, application and reliability requirements.
-Lead the component/material approval process by partnering with suppliers to ensure components/materials and sub-assemblies are qualified to the appropriate requirements prior to commercialization.
-Develop and execute characterization/qualification protocols and reports in partnership with selected suppliers.
-Lead suppliers in the development of control plans for critical components/materials to ensure appropriate acceptance activities are in place prior to commercialization.
-Partner with TSS and the broader Supplier Management organization to develop commodity strategies that balance business, quality, and technical requirements.
-Partner with design engineers to determine future component and raw materials needs; develop and maintain technology roadmaps.
-Partner with Technical Sourcing to find and develop suppliers that can meet Client
Title: Quality Engineer
Location: Santa Rosa, CA “LOCAL ONLY”
Duration : 7 Months
Job Duties :
-Completes Design History File documentation
-Creates and delivers presentations throughout the organization
-Design of Experiments (DOE) and Statistical Process Control (SPC)
-Determines manufacturing operation requirements and process parameters
-Develops advanced manufacturing systems and processes
-Develops and implements strategic plans
-Develops plans to evaluate process repeatability and stability
-Develops product and process improvements
-Participates in internal supplier audits
-Participates in procedure writing and review
-Performs process and equipment validations
-Provides technical support to other engineers
-Specifies and implements process lay-outs
-Supports manufacturing, development, and implementation processes
-Utilizes FMEA within process development
-Ensures compliance with GMP's
-Generates documentation for engineering protocols and reports
-Implements quality system improvements
-Writes engineering and manufacturing specifications
Skill Sets:
Required:
Desired:
Certifications/ Engineering:
Design Controls, DHF, and Engineering Documentation
QS, 21CFR - GMP/QSR, 29/40CFR, title 8, and NRC Compliance
Education Level:
Undergraduate Degree
High School Diploma or Equivalent
Industry Experience:
1 - 3 Years
Oral Communication:
Excellent
Facilitation Skills
Travel:
10-25% Travel
Written Communication:
Excellent
Legible Handwriting
Certifications/ Engineering:
ASQC
ISO 9000, 9001, 9002 Certification Preparation
Education Level:
Quality or Reliability Certification
Industry Experience:
3 - 5 Years
Greater than 5 Years
Greater than 10 Years
Supply Chain Management Packages:
SAP
Agile
eMatrix
Position Description
-As a Contract Component Engineer you will have the responsibility for partnering with Design Engineering and Technical Sourcing (TSS) to identify, develop, qualify, document and release cost effective components/materials from a variety of commodities for use in Client CardioVascular products.
-In this area of new product development you will be required to drive multiple aspects of component/material development and approval with suppliers as a member of a cross-functional team.
Position Responsibilities
-Provide project team support across multiple commodities (e.g. plastics, electronics, metals, chemicals, fabrics, sutures, OEM) as the resident component/material expert.
-Partner with Technical Sourcing to locate, evaluate, and approve new potential component/material suppliers for active projects.
-Perform process and component/material development work with suppliers to deliver on-time components/materials that meet downstream manufacturing, application and reliability requirements.
-Lead the component/material approval process by partnering with suppliers to ensure components/materials and sub-assemblies are qualified to the appropriate requirements prior to commercialization.
-Develop and execute characterization/qualification protocols and reports in partnership with selected suppliers.
-Lead suppliers in the development of control plans for critical components/materials to ensure appropriate acceptance activities are in place prior to commercialization.
-Partner with TSS and the broader Supplier Management organization to develop commodity strategies that balance business, quality, and technical requirements.
-Partner with design engineers to determine future component and raw materials needs; develop and maintain technology roadmaps.
-Partner with Technical Sourcing to find and develop suppliers that can meet Client
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