Location: Rancho Cordova, CA
Duration: 6 Months
The Quality Compliance Specialist will support the activities of the corporate CAPA, Training, and Audit programs. The perfect candidate will have in-depth knowledge of GMP QSRs and ISO 13485, and proven success in cross functional teamwork.
DUTIES AND RESPONSIBILITIES:
• Coordinate the activities associated with the site, business and global corporate CAPA system.
• Coordinate and consolidate quality metrics for use in various quality meetings, including Management Review.
• Responsible for creating, implementing, controlling, and publishing scheduled management reporting systems metrics and reports.
• Assist with the site and corporate Training program by monitoring compliance metrics and working with individuals across the organization to address training needs.
• Assist in the development and delivery of training associated with the corporate CAPA, Training program, root cause analysis and audit programs.
• Manage Internal Audit program. Conduct and/or support internal audits including but not limited to supporting business unit internal audits, reporting on the results of the audits to leadership, trending and driving changes associated with internal audit observations.
• Assist with complaint handling processes for trending and analysis.
• Support external audits and as required act as a subject matter expert for Rancho Cordova quality management systems and when appropriate act as the external audit/inspection facilitator.
• Perform other duties as required included but not limited to interaction with site leadership team on various QMS deliverables, driving quality culture across shared resources and factory, and implementing data acquiring metrics that are efficient, reliable and capable of driving timely decisions.
• May also be required to review test protocols and reports for, new product development, product requiring continuous improvements and IT driven testing for quality management software testing.
MINIMUM QUALIFICATIONS, KNOWLEDGE, SKILLS AND ABILITIES:
• Clear and effective verbal and written communication skills
• Solid understanding of FDA QSRs and ISO 13485
• Proficient computer skills – MS Office Suite (Outlook, Word, Excel, PowerPoint, Visio, etc.)
• A 8 yr working experience as quality engineer with minimum 5years of experience in Medical Device industry preferred. Experience in program management is also preferred.
• BS / BA degree preferred
• Good understanding of multiple quality management systems tools for training, CAPA system, NCR system, Change management, and document control.
• 10% to 25% travel required including international locations.
• Work is generally conducted in an office environment.
• This job requires the use of a computer and common office equipment.
• Airline travel is required at times.
• Ability to lift 25lbs
APN Software Services INC
39899 Balentine Drive, Suite 385, Newark, CA 94560