Quality Program Manager

Location: Fremont, CA, United States
Date Posted: 08-31-2017
QA Program Manager:
Supports the organization with initial compliance and ongoing preparation, testing and monitoring of conformance to established quality assurance processes and standards for manufacturing and production. Performs evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards. Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately remedy them. Facilitates internal training on quality assurance requirements, processes, and procedures. May perform audits and risk assessments.
Specific Responsibilities: (Other Duties May be Assigned)
  • Lead the design, implementation and maintenance of quality assurance systems within the plant
  • Lead core Quality Management System activities including  internal audits, customer and external audits, CAPA investigations, Management review/ follow-up, Management of change champion and owner 
  • Provide CAPA process ownership including root cause investigation, Corrective Action assignment, communications, CAR follow-up, closure effectiveness, metrics
  • Support and maintain ISO 9001 certification.
  • Support development and implementation of site specific continuous improvement plan in conjunction with overall business improvement objectives
  • Recommend, champion and implement new ideas for processes to improve quality and to support expansion of profits and product / process integrity
  • Develop and analyze statistical data and process specifications to determine conformance standards and establish proposed quality expectancy of processes and product conformance to customer requirements.
  • Interact with the Site Management Team, Sales and Customer Service personnel relating to quality issues.  Consult with all involved parties in regard to customer quality problems to determine and effect short term immediate corrective actions and root cause determination of a problem in order to implement all required preventive actions
  • Plan, promote and organize training activities related to product / process quality and worker effectiveness
  • Support customer reporting activities -  working with Operations team to review collected process performance data prior to providing to customer
  • Manage process adherence – using SPC to understand process performance
  • Manage Periodic Process Performance Validation
  • Support Process Development and Process Transfer activities
  • Support development of Product Quality Plans
  • Develop and distribute site performance metrics, and evaluate for continuous improvement opportunities
Responsibilities, Continued:
  • Support NCE process - investigation, AR follow-up, closure,  metrics
  • Manage control of non-conforming products.
  • Conduct Supplier Quality audits, complete scorecards
  • Develop and support Supplier CIP w/ follow-up, metrics
  • Receive, review and respond to customer scorecards and CIP’s
  • Manage and support training development for CI, and Quality
  • Audit site compliance to Overall Training Adherence
QUALIFICATIONS:
  • BS degree in Engineering/Science or direct equivalent work experience
  • 3 to 5 years’ experience within the Quality Assurance organization of a manufacturing / service organization
or
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