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SUMMARY

Under minimum supervision, Associate Manager, Complaints will be responsible for supervising the Failure Analysis of Complaints and Complaints Handling and Coordination of complaints. This individual will also be responsible for maintaining the quality processes associated with product complaint handling, procedures, and controls to ensure that all complaints are processed in accordance with established company procedures and worldwide regulations and standards.

RESPONSIBILITIES

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate Integra procedures and guidelines, this position:

Responsible for Complaint coordination, management, and closure.

Will receive complaints from corporate and determine where the investigation will take place and drive the complaint to closure.

Responsible for assuring compliance with timeliness metrics.

Develops, mentors, plans and coordinates workload for Complaints Quality Engineers and Complaints Analysts.

Responsible for conducting Performance Reviews and set Goals & Objectives for Complaints Quality Engineers and Complaints Analysts.

Plans, develops, coordinates, and directs projects with varying levels of complexity.

Ensure compliance with the company’s Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies, Integra Environmental, Health & Safety Practices, and other applicable standards as pertains to medical devices.

Responsible for ensuring the Complaints Handling documents all required information for complaint files is obtained and properly documented to make sound regulatory reporting decisions.

Evaluates all information form a clinical and technical perspective to ensure appropriate Analysis, investigation, Root Cause, and Quality Engineering review is documented prior to complaint closure.

Point of Contact for the corporate complaint group.

Responsible to coordinating complaint returns to suppliers and external manufacturers.

Establish reports for the prompt review and investigation of complaints.

Possess a thorough understanding of the complaint database.

Ensure the development, preparation, analysis, and presentation of trend reports for complaints.

Set up complaint meetings and effectively communicate with complaint groups, as well as other internal departments such as Marketing, R&D, Customer Service, and Technical Services.

Understands principles, theories concepts and techniques related to customer complaints.

Investigate and develop solutions to procedure and process related issues. Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.

Initiate and investigate Corrective and Preventive Actions (CAPA) as appropriate. Assist in complaint analysis

Work is expected to result in the development of new or improved techniques or procedures.

Responsible for communicating business related issues or opportunities to next management level.

Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.

Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.

Performs other duties assigned as needed.

QUALIFICATIONS

Experience and Education:

Bachelor degree with 3+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience, preferably in engineering, physical sciences, or biological/natural sciences.

OR Master degree with 0-2 years of experience leading a team or equivalent education and years of management experience preferably in engineering, physical sciences, or biological/natural sciences.

Required Skills

Supervisory and leadership skills

Regulatory compliance knowledge

Excellent interpersonal skills

Advanced Quality Assurance and Quality Systems knowledge

Problem solving

Statistical Skills

Must possess the basic understanding of engineering fundamentals

Good written and oral English communication skills

Must be computer literate

American Society for Quality (ASQ) certification, Six Sigma experience, and/or knowledge of Process Excellence tools is desirable