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Quality Assurance Manager

Redwood City, California 94063 | Direct Hire

Post Date: 03/12/2018 Job ID: 18186 Industry: Hardware

Position Title: Quality Assurance Manager

Position Description:   Our client in Redwood City, CA is looking for either a Senior or Junior Quality Assurance Manager to join their team.

Job Responsibilities:
  • Develop, deploy, and execute Quality Policies, Quality Objectives, and Quality Plans that are in line with and support the client' s global  Quality Management System and corporate quality goals.
  • Serve as the Management Representative for the client site.
  • Support, develop, implement, and maintain all QMS processes and procedures across the site.
  • Initiate improvements to the Quality Management System, ensuring compliance to all relevant Quality Standards and Regulatory requirements.
  • Ensure effective coordination of investigations, root cause analysis, risk assessments and implementation of change controls, Corrective, and Preventive Actions to the adhered timelines as appropriate. Initiate updates/tracking on status of Non-conformances and CAPAs as appropriate.
  • Responsible for implementation, support, and maintenance of computer systems used for QMS processes.
  • Monitor and audit the QMS processes for compliance, effectiveness, continued alignment with applicable regulatory and statutory requirements, and opportunities for improvement.
  • Maintain Quality System Dashboards, Scorecards / Key Performance Indicators for the quality system processes. Review and monitor trends, communicating out-of-norm issues to department management.  Contribute to and assist in providing quality system training as appropriate.
  • Collect, analyze, and present data on the QMS status during Quality and Management Review Meetings.
  • Site representative for audits from external regulatory authorities and registration agencies.
  • Ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with corporate  values.
  • Manage department personnel and resources

Job Qualifications:
  • BS in related scientific or technical discipline
  • 3-5  years of successful experience in the medical device industry, some of  which should be in a quality assurance environment. (10 yrs. exp in medical device industry for Sr. candidates)
  • Ideally experience in managing technical personnel
  • Strong working knowledge of ISO 13485, QSR, & MDD regulatory standards
  • Cleanroom, sterilization, and embedded systems
  • Hands on experience with Risk Management standard (ISO 14971)
  • Working knowledge of validation (product, process and sterilization)
  • Excellent communication skills with the ability to interact with all levels in the organization.
  • Knowledge of document control systems; including records management, change order process, and document distribution and retrieval.
  • Successful experience working in team environment.

About Protingent:  Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding and exciting work opportunities for our candidates.

Jeff Morgante

I have an ability to connect with engineers easily, with an engineering background myself, I can relate and communicate using the same language. I have been working in Technical staffing at Protingent since 2011. I have two dogs, Kaleb & Kayce and two cats, Mika and Shiloh. I am originally from upstate New York, but love living in the Pacific Northwest! I have a passion for cars, old and new.

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