Current Job Openings

Department: Quality (Operations)
Job Title: Operations Quality Manager
Location: Menlo Park, CA

Job Summary:

Manages Operations Quality activities

Duties & Responsibilities:

• Manages the daily activities related to Production Quality to ensure that uninterrupted flow of quality product is available to the customer. Activities include, but are not limited to: controlling and enhancing product quality, coordination of MRB activities, NCMR reporting, QA Testing, QC Inspection, Environmental Monitoring, Calibration, etc.
• Provides Quality Engineering leadership and guidance for a group of engineers, technicians and inspectors. Leads the Quality team in performing system and process improvements. Supports and promotes CAPA activities to enhance the quality of released products.
• Manages Receiving Inspection activities and Supplier Quality program, oversees supplier audits and supplier performance. Drives resolution of quality issues related to suppliers.
• Ensure adherence to short and long range quality plans and corporate goals.
• Promotes an environment that ensures compliance with relevant safety regulations, QSRs, ISO Standards, etc.

The successful candidate must possess:

• BS degree with minimum of 5 years of broad quality assurance/operations management experience. CQE / CQM are preferred.
• Thorough knowledge of FDA Quality System Regulations, ISO 13485:2003, Medical Devices Directives and other applicable International Standards
• Excellent verbal and written communication and interpersonal skills, demonstrated leadership skills and problem solving abilities.
• Strong analytical, financial and budgeting skills.