Quality Assurance Manager
400 Seaport Ct. Suite 103 Redwood City, California 94063 | Direct Hire
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.
- 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
- 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.