Title: Complaints Handling Specialist (Medical)

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.