Complaints Handling Specialist (Medical & Complaint Handling Exp)
MILLENNIUMSOFT, San Antonio, TX, United States
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.
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.