Director - Complaint Handling - Volcano Corporation - San Diego

Job description
About the Position: This highly visible and critical position is based in San Diego, CA and this position oversees the processes and the personnel responsible for managing the product complaint handling associated with commercial products.
This is a leadership role and will be responsible for interacting with key stakeholders in driving a culture of shared accountability for managing the outcomes associated with product complaint investigations and management processes.
This individual will ensure that the complaint handling and the safety reporting processes across the globe are timely, consistent, uniform and efficient. This role will help establish a center of excellence in complaint handling/adverse event reporting, and develop an organization, strategy, processes, goals, and metrics to drive measurable improvements in complaint handling.
The person will have the responsibility of all aspects of complaint management process included reporting on key metrics to the senior management per procedure and when required per procedure will escalate issues to the leadership. This role will lead the training effort for the company and its subsidiaries for the responsibilities and requirements of identification and reporting of complaints.

Duties and Responsibilities:
Manages and develops the complaint handling organization including, complaint investigation, complaint call center and complaint management center functions.
Serves as a Subject Matter Expert on all aspects of complaint handling processes including MDR/MDV and must have clear understanding of the intent and the application of the regulatory law.
Communicates and collaborates with cross functional teams such as Clinical, R&D, Quality, Customer Service, Technical Service, Operations, Distribution centers, Sales force and global regions leveraging shared accountability process to resolve complaints in timely manner including ensuring that the corporate goals and strategies for complaint handling are met.
Establishes and manages annual budget for the organization and work with QA leadership and finance team in achieving budget goals.
Ensures implementation, effectiveness and integrity of the complaint handling system by establishing procedures and processes that are compliant to 21 CFR Part 820, 21 CFR Part 803, ISO 13485, JPAL and ISO 14971.
Leads management of related third party Quality System inspections, including FDA, notified bodies and all other regulatory bodies associated with the complaint handling processes.
Interprets global regulations for complaint handling/post market surveillance processes and associated compliance standard requirements for incorporation into the company systems/procedures related with complaint handling and general post market surveillance requirements.
Actively participates in company continuous improvement initiatives including involvement in IT solutions pertaining to complaint management system.
Identifies gaps in complaint handling process as it relates to complaint investigations/evaluations, MDR/MDV reporting, product and process metrics, and trending to maintain seamless compliance and develops feasible plans for timely correction.
Develops, oversees, and ensures robust reporting and metrics trending in order to meet business, corporate, and functional strategic objectives; prepares written reports to management on findings and is integral to the process of developing corrective and preventative actions associated with findings.
Involvement with investigations and/or product complaints with focus on Root Cause Analysis (RCA).
Establishes a standard process to escalate incomplete or overdue complaint investigation/adverse events and resolution tasks to the management of the responsible task owner.
Chairs relevant complaint review meetings to drive closure and meet reporting timeline requirements.
Collaborates with cross functional teams to establish a monthly product performance complaint review board to review and where necessary take action on product complaint trends and safety events.

Desired Skills and Experience
Minimum Qualifications, Knowledge, Skills and Abilities:
Requires a Bachelor's degree in a Technical, Science, or Engineering discipline.
A Master's degree and/or MBA preferred
Knowledge and Experience (Scope & Complexity):
Senior level position with routine expectations to work closely with senior members of cross functional leadership team.
Able to work independently, make critical to complex decisions and direct other resources on complaint handling and quality compliance decisions related to complaint handling and safety reporting activities.
Responsible for providing supervision and oversight for the quality functions associated with complaint management, complaint call center, and complaint investigation including lab.
May be required to take on additional roles such as failure investigation engineers.
Manages exempt and nonexempt staff; makes hire, performance evaluation, termination, promotion and merit decisions
Requires 10 + years of experience in quality assurance in the medical device industry - a minimum of 6 + years in a management role in complaint handling in medical devices.
Must show a proven experience in leading others with a proactive attitude.
Demonstrated knowledge and hands on experience of applicable FDA regulations and international standards.
Must possess good program management skills to ensure timely completion of projects within the organization.
The person should exhibit high performance behaviors of trust, shared accountability, sense of urgency, listening and learning, growth and help others grow, and benchmark for continuous improvement.
Knowledge and experience of a wide range of medical devices particularly interventional cardiology products and associated capital systems hardware desired.
Shown hands on experience in providing solutions to complex problems using critical to quality principles such as cause and effect, the 5 why's, statistical tools including various distribution methods and pro-active quality planning.
Advanced Microsoft Office skills.
Ability to communicate effectively both orally and in writing and to establish and maintain cooperative working relationships with persons contacted in the course of performing assigned duties including Company management and outside business associates.
Strong attention to details.
Ability to maintain confidentiality.
Ability to organize and prioritize workflow and to meet established timeframes.
Ability to maintain updated knowledge of procedures, products and activities of assigned area.
Ability to adhere/respond to established time frames and schedules.
Ability to operate a personal computer and related software.
Ability to work under pressure.
Ability to coordinate the work of others.
Ability to interact with senior management on a regular basis.
Ability to represent the Company at professional and business functions in a competent manner.
Problem solving and decision-making capability that includes systematically analyzing problematic situations and developing solutions consistent with organization objectives.
May be required to travel both domestically and internationally to Volcano offices, customer and/or vendor locations, up to 10-15% as needed (typically Rancho Cordova and occasionally to Costa Rica and Customers)

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