Title: Complaints Handling Specialist (Medical & Complaint Handling Exp)

Location: San Antonio, TX

Duration: 12 Months

Hours: 40:00

 

Description:

·         Under the direction of the Complaints Management and Customer Quality Relations Manager, the Quality System Specialist II, will manage activities and procedures associated with complaints concerning Client products.

·         This position will be responsible for processing of product complaints including but not limited to customer communication (e.g. Email’s, phone calls), maintenance of complaint files and responses to customers.

·         This position will create final letters and or review for accuracy to ensure that all customers’ requirements have been met.

·         This position will also be responsible for escalation of quality issues, in order to get resolution and or Business responses for the customer.

·         Additional responsibilities may be delegated by the Complaints Management and Customer Quality Relations Manager as needed.

 

Responsibilities:

·         Manage the process of the complaint handling system including, receipt of complaints from all sources and all in process steps including data entry.

·         Routing the complaint to appropriate location for further evaluation.

·         Entering of the complaint into the complaint handling system

·         Checking for complaint accuracy and content, correct information to process the complaint

·         Provide training to personnel involved in overall complaint process as directed by management.

·         Participates in all training classes including but not limited to, product training, regulatory training, compliance training and any testing involved.

·         Maintains annually competencies through training and documentation of training.

·         Contact the customer or vendor for further information or follow up.

·         Acknowledgement to the customer of receipt and status of the complaint if needed.

·         Sample routing when applicable, to the investigation site

·         Interact with Health Care Workers, consumers, public and other professionals regarding their Quality concerns.

·         Maintain customer relations via multiple means, written, verbal, phone call’s… etc.

·         Contact customers as needed to provide updates to outstanding quality issues.

·         Review of complaint prior to closure for accuracy and appropriateness of the letter content as well as follow up acknowledgement notice, if required.

·         Triage customer escalations and escalate to the Business units for response and resolution as needed

·         Perform history check on previously submitted complaints by customer to ensure that the customer is receiving an appropriate closing response.

·         Ensure that the customer compliant complies with all relevant procedures

·         Demonstrate technical competencies in mechanical, clinical and functional in relation to all Client products and areas.

·         Remain current in product knowledge and any upgrades to complaint handling systems.

·         Create and review closing letters for accuracy and to ensure right the first time approach to customer communications.

·         Maintain expert knowledge level of the compliant handling system

·         Provide feedback to management for compliant process improvement opportunities (e.g., complaints systems, final letters, escalations process, etc...)

·         Provide training to peers as requested by management.

·         Raise any escalated customer concerns to the next level of management

·         May perform other duties as required

 

Skills:

·         Demonstrate good documentation practices for each interaction reported by customer.

·         Maintain in-depth knowledge of Company, Department and quality products, processes and policies.

·         Works in close coordination with other teams to meet resolution and quality expectations.

·         Works closely with compliant management team to ensure compliant process is being followed and is meeting all quality and customer needs.

·         Assisting multiple functions of the organization to assist with the product compliant handling and/or Quality functions.

·         Participate in mentoring and training activities.

·         Strong analytical, deductive reasoning and listening skills

·         Must be able to communicate precisely and accurately to all levels of the organization

·         Strong interpersonal skills

·         Strong Project management skills

·         Demonstrated aptitude for identifying creative solutions to complex customer issues’ ability to “think outside the box”

·         Excellent time management and multitasking skills

·         Excellent written and verbal communication skills

·         Works well in a team environment

·         Strong personal commitment to quality, customer service and patient safety

·         Business and computer skills

·         Must be motivated, self-directed and able to work with minimal supervision.

 

Education and Experience:

·         BA or BS degree preferred and/or combination of education and relative experience in lieu of a degree

·         Minimum 1+ years of experience with Medical terminology, Nursing, Clinical or laboratory knowledge and familiarity with Client products

·         Minimum 2+ years of experience in the complaint handling, medical device industry, customer relations, complaint trending, FDA/ISO regulations.