Spec 3, Complaint Mgmt

KAYGEN is an emerging leader in providing top talent for technology-based staffing services. We specialize in providing high-volume contingent staffing, direct hire staffing and project-based solutions to companies worldwide ranging from startups to Fortune 500 and Managed Service Providers (MSP) across a wide variety of industries.

KAYGEN is an emerging leader in providing top talent for technology based staffing services. We specialize in providing high-volume contingent staffing, direct hire staffing and project based solutions to companies worldwide ranging from startups to Fortune 500 and Managed Service Providers (MSP) across a wide variety of industries.

Any questions you have should be directed to Terri Abate you are not to reach out to the manager.

Sr. Complaint Specialists, Designated Complaint Handling Unit (DCHU)

Max Bill is

Job Description Summary

The Sr. Complaint Specialist Investigation Lab role is responsible for medical device post-market surveillance as it relates to complaint handling functions. The role is responsible for the completion of all tasks associated with complaint handling including : investigation of failed product, working with hazardous materials in controlled lab environment, writing clear and effective failure investigation reports, review of reported events in the complaints database for trending and optimal root cause identification, handling and properly dispositioning parts for investigation, and resolving issues. Additionally, provides technical expertise / troubleshooting for internal and external customers when requested.

Duties & Responsibilities

• Conduct product complaint investigations and write failure investigation reports
• Ensure accuracy for complaint file documentation and regulatory reporting decision activities.
• Ensure complaint files are accurate and complete and in line with good documentation practices.
• Demonstrate sound independent decision making in regard to medical device complaint handling and other functions relating to the investigation of product complaints. Asks questions of team leaders / management as needed.
• Provide or facilitate clinical expertise / troubleshooting for customers as appropriate.
• Collaborate with supervisor, manager to assess the severity of complaints and understand the typical use to provide input to the Technical investigation for optimal root cause resolution as needed.
• Handle product for investigation per quality system requirements
• In concert with the department supervisor and / or manager and escalation teams, strategize to direct the efforts to ensure Dispensing customer satisfaction.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Ensure timely follow-up with internal customers and company representatives for reported issues.

Qualifications :

Education & Experience

Knowledge, Skills & Abilities

Flexibility and excellent organizational skills to manage / adapt to competing priorities and volume of tasks.

Note : Job requires flexible schedule. Training will be on 1st shift 8Am to 5PM in San Diego. For 5-6 months in San Diego, 11-7pm, then once job moves to Otay it will be first shift.

At KAYGEN, we are always looking for dynamic, talented and experienced individuals. We invite you to join our team of talented IT professionals, consulting at client locations across the globe. Our culture is team-orientated; we strive to stand by our core values of respect, honesty and integrity. Our team of experienced staffing experts will work with you to find you the best opportunity. For more information please visit us at www.kaygen.com.

Benefits with Kaygen

Healthcare Insurance

Vision and Dental Insurance

401(k) Retirement Plan

Free Life Insurance

Vacation Time Off

Sick Time Off

Family Medical Leave (FMLA)

Achieve your Kaizen by clicking here. A unique and exclusive talent community supported by Kaygen, that includes programs like :

At KAYGEN, we are always looking for dynamic, talented and experienced individuals. We invite you to join our team of talented IT professionals, consulting at client locations across the globe. Our culture is team-orientated; we strive to stand by our core values of respect, honesty and integrity. Our team of experienced staffing experts will work with you to find you the best opportunity. For more information, please visit us at www.kaygen.com.

Benefits :

Achieve your Kaizen by clicking here. A unique and exclusive talent community supported by Kaygen, that includes programs like :