Chandler Robak Email & Phone Number

Mountain View, Ca, Us

• Perform oversight of the Complaint Handling process and ensure timely processing of complaints by the Complaint Handling Unit (CHU). • Conduct the Bi-Monthly Complaint Review Meetings with CHU Staff and Quality Assurance. • Compile complaint data for the Complaint Review Meeting and conduct trending analysis for the Quarterly Management Review Meetings (MRM).• Conduct post-market surveillance, provide Tier 1 customer support to a global customer base, while adhering to company’s Quality Management System for post-sale service and ensuring compliance with US FDA, and international medical device regulations.• Coordinate the Complaint Handling Unit (CHU) in activities to prepare for audits and inspections. • Coordinate with other departments to provide complaint data reports, as needed.• Support the required event reporting and investigation of all medical device complaint-related procedures, in accordance with the FDA and other Notified Body Regulations • Direct communication with Internal Stakeholders (Senior Management, Complaint Handling Unit (CHU) staff, Manufacturing, Engineering, Purchasing, Sales, and Quality Assurance)• Excellent skills communicating with healthcare providers, biotechnicians, patients, and repair technicians. • Work with cross-functional CAPA investigation teams, to identify the root cause of Product Nonconformances.• Successfully implemented and integrated a new Complaint Handling Software

• Responsible for Medical Device Complaint Intake, Documentation, Evaluation, Research and Coordination of Complaint Follow Up and Resolution• Communicate with health care providers (HCP), HCP staff and/or patients to acquire relevant complaint information.• Conduct post-market surveillance and provide Tier 1 troubleshooting for customers via phone, and email, administering RMAs, and general account maintenance for a global customer base.• Adhere to company’s Quality Management System for post-sale service and ensure compliance with FDA and International Regulations.• Part of cross-functional team to investigate product failures, compile and analyze complaint data.

La Jolla, Ca

• Assemble and provide auditors with requested financial documentation for yearly audit. • Develop procedures for organizing financial and legal documents on-site.• Track fixed asset accumulation and depreciation for quarterly and yearly financial statements.

La Jolla, Ca

• Organized and cataloged 5 years of financial and legal documents for transfer to offsite storage. • Entered and maintained vendor profiles in accounting software, and record invoices for 14 companies•Generated fixed asset inventory and new-year templates•Renewed 14 business licenses for 2018•Year end filing

La Jolla, California

• Organized and cataloged 5 years of financial and legal documents for transfer to offsite storage. • Assembled and provided auditors with requested financial documentation for yearly audit. • Entered and maintained vendor profiles in accounting software, and record invoices for 14 companies•Generated fixed asset inventory and new-year templates•Renewed 14 business licenses for 2018•Year end filing

Santa Clara, California

• Worked with a team to check guest tickets prior to their entrance to the executive’s club.• Provided guest directions to various locations throughout the stadium.• Collaborated with the NFL during Super Bowl 50 to assist guests before, during, and after the event.

Mountain View, California

• Supervised the sales floor when managers were in the office to keep track of lunches and breaks for all employees. • Trained new associates, and assisted with general inquiries from associates and customers. • Responsible for the furniture department: maintained stock of chairs, maintained strict presentation standards of the department; Lead salesman for all furniture related questions and purchases. • Assisted the Copy & Print Department as main source of backup to help the team reach deadlines for high volume projects.

• Maintained multiple cancer cell lines in tissue culture• Assisted in tumor measurement in mouse xenograft models• Optimized in vitro cell proliferation assay• Tested in vitro activity of therapeutic monoclonal antibody in cell proliferation assay

San Jose, California

• Part of program developing protocol optimization for Thin-layer Chromatography• Including reagent preparation • Maintained laboratory notebook for experimental documentation.

Poway, California

• Worked towards my black belt in Kenpo Karate for 7 years• Achieved my 1st degree black belt in July 2013 • Instructed both group classes, and one-on-one sessions for students of all ages and ranks