What are the responsibilities and job description for the Complaints Management position at MillenniumSoft Inc?
Job Title - Complaints Management
Location : San Antonio,TX
Duration – 12 Months Contract]
Total Hours/week - 40.00
Shift Work days/hours : M - F 8am - 5pm(Initial training onsite. 1 day on site/the other 4 remote once training is complete)
Job Description
Location : San Antonio,TX
Duration – 12 Months Contract]
Total Hours/week - 40.00
Shift Work days/hours : M - F 8am - 5pm(Initial training onsite. 1 day on site/the other 4 remote once training is complete)
Job Description
- Under the direction of the Complaints Management, the Complaint Specialist, will manage activities and procedures associated with complaints concerning BD products including reviewing customer surveys/ reviews, and potentially filing the Medical Device Reports (MDR’s) associated with complaints to the FDA.
- This position will be responsible for processing of product complaints including but not limited to customer communication (e.g., Email’s, phone calls) and interacting with health care workers,
- consumers and other professionals regarding their product quality concerns.
- Additionally, this position will be responsible for maintenance of complaint files and responses to customers.
- Additional responsibilities may be delegated by the Complaints Management as needed.
- Manage the process of the complaint handling system including, receipt of complaints from all sources and all in end-to-end complaint process steps.
- Checking for complaint accuracy and content, correct information to process the complaint
- Triage complaint and determine required information needed to assist in reportability decisions and robust product investigations.
- Follow procedures to ensure timely and accurate execution/review of decision trees.
- Draft and Submit MDRs (Medical Device Reports) as needed to with the FDA
- Ensures compliance with all BD policies and procedures
- Routing the complaint to appropriate location for further evaluation.
- Interface/Communicate with Customers via Phone, Chat, Email as needed.
- 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.
- 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.
- 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 BD 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 systems to monitor and facilitate the timely reporting of MDRs and supplemental MDRs.
- 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
- Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, ISO 13485 and Canadian Regulations
- Product knowledge: understanding of product usage and the ability to differentiate between significant and non-significant health risks to either patient or healthcare worker)
- Knowledge of product failure modes
- Ability to work with customer system administrators and clinicians
- Proven ability to maintain a professional demeanor when handling complex user issues and high-pressure situations
- Expert level knowledge of the Complaints handling system
- Proven ability to multi-task and seamlessly move between business unit platforms.
- Ability to take ownership and think independently, with minimal supervision
- General knowledge of producing metrics and building reports.
- 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.
- Continuous and versatile learner
- BA or BSc degree in Science, Engineering, Health Administration, Nursing, or (2)yrs. relative experience, and college courses in lieu of a degree.
- Minimum 1 years of experience with medical terminology, Nursing, Clinical or laboratory knowledge and familiarity with BD products
- Minimum 2 years of experience in the complaint handling, medical device industry, customer relations, complaint trending, FDA/ISO