Position : Complaints Handling Management Specialist
Location : San Antonio, TX
Duration : 12 Months
Total Hours/week : 40.00
1st Shift
Client: Medical Device Company
Job Category: Healthcare
Level of Experience: Entry Level
Employment Type: Contract on W2 (Need US Citizens or GC Holders Only)
Workdays/hours: M - F 8am - 5pm
Note:
*Initial training onsite. Potential for Hybrid once training is complete*
Job Description:
Primary Responsibilities and Duties
- Manage the process of the complaint handling system including, receipt of complaints from all sources (including Service Cases and Work Orders) 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
KSA Requirements (Knowledge, Skills, and Abilities):
- Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, ISO 13485, and Canadian Regulations
- Ability to work with customers, 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.
Education/Degree:
- AS degree in nursing, Scientific or other relevant field.
- Experience (in years)
- 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.