Customer Quality Manager
2 months ago
Duties and Responsibilities
Provides direction, motivation, and support for department personnel. Provides leadership to complaint handling staff to ensure complaint files are processed in a uniform and timely manner.
Ensures that each staff member has clearly established goals and objectives, monitors staff performance, conducts periodic performance evaluations and compensation planning, and ensures succession planning for key positions, including own.
Develops, coordinates, and otherwise ensures appropriate training for associates. Ensures individualized developmental plans are in place for all associates.
Reviews and continuously leads efforts to improve the global complaint handling process. Maintains and continuously improves highly effective procedures for complaint processing and complaint investigation.
Collaborates with the Field Service Engineering, manufacturing, international and other departments to ensure complaint investigations are complete, thorough, timely and meet regulatory reporting requirements.
Maintains dashboards and other reports of performance metrics. Measures key performance indicators to assess the health of the complaint investigation process. Provides regular updates and status reports to senior management.
Initiates Company Issue Escalation Process as Required.Investigates and Documents Complaint Trend Analyses.
Initiates Company CAPA Process as Required.
Authors and Approves Customer Response Letters.
Coordinates Efforts with ASP Legal Department for Complaints Regarding Litigation.
Responsible for communicating business related issues or opportunities to next management level
Performs other duties assigned as needed
Qualifications:
5-7 years of related experience, including significant experience working in pharmaceutical, consumer, medical device or another highly regulated industry.
Proven leadership in developing and coaching staff.
Advanced critical thinking and investigation skills are required.
Ability to multitask, including ability to understand customer requirements, retrieve relevant information, and provide responses satisfactorily and with immediacy is required. Employee must be able to effectively prioritize and manage multiple activities and responsibilities.
Ability to understand and follow complex written procedures is required. Candidates should be familiar with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices.
Ability to function in a team environment and deliver on team objectives is required. Ability to influence and drive change is preferred. Prefer project management and/or process mapping experience.
Strong Verbal and Communication Skills: Strong written and verbal communication skills are required.
Must be highly proficient in reading, writing, and speaking the English language. Prefer developed presentation skills.
Professional demeanor on the phone and in email is required. Technical writing is a routine part of this position. Strong attention to detail is required.
Required Computer Skills: Familiarity with computers and Windows-based PC applications. Ability to learn and manipulate complex computer system applications is required. Ability to type at least 50 words per minute (WPM) is required. Experience with word processor software (e.g. Microsoft Word) and internet browsers (e.g. Internet Explorer) are required. Prefer experience with electronic Complaint Management Systems.
Normally receives no instructions on routine work, but work is reviewed and approved upon request.
Receives general instruction on new tasks. Detailed initial training on procedures and software is provided.
Prefer prior medical device complaint handling experience, or knowledge of medical device regulations.
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