IMMEDIATE OPENING!!

A laboratory office of Medical Devices and Reagents Supplier is seeking an experienced Quality Assurance Manager.

This position requires to work at the office in Dublin, CA daily base.

Responsibilities:

• Design, implement, and improve company quality standards.
• Interpret, build upon, and comply with company quality assurance standards.
• Carefully maintain complaint and nonconformance processing through records and tracking systems, including root cause and corrective actions.
• Document quality assurance activities with internal reporting and audits.
• Respond to audits.
• Analyze data in order to find areas for growth.
• Assist in the recruiting process.
• Training, motivating, coaching, and correcting employees to ensure that standards are met.
• Create reports to track progress.
• Formulate strategies to increase productivity.
• Review processes in order to ensure that they align with current trends.
• Strong organization and management skills.
• Correspond to regulatory affair matters (FDA, IVDR, etc).

Other requested by the management

Requirements:

• BS/BA degree in a science-related or technical field
• Minimum 5 years related experience working in a professional environment where compliance was of vital importance
• Working knowledge of Quality Assurance in a medical device manufacturing environment
• Knowledge of Quality System Regulations and/or Audit ISO 13485
• Must be able to write in a manner that effectively conveys complex issues to the reader
• Strong communication, problem-solving and motivational skills
• Demonstrated ability to carry out assignments in a timely, accurate manner and accomplishing tasks as required with little or no supervision

Preference:

Have the knowledge of MDSAP.

Have the experience of the audits of MDSAP.

To apply, please send resume to itatebayashi@pasona.com