Complaint Management Specialist

Intellectt INC
San Antonio, TX Full Time
POSTED ON 6/7/2022 CLOSED ON 6/13/2022

What are the responsibilities and job description for the Complaint Management Specialist position at Intellectt INC?

Role: Complaint Management Specialist II

Location: San Antonio, Texas, USA78249

Duration: 12 months on W2

Description:

Work days/hours: M - F 8am - 5pm local time.

**Must be located in driving distance to San Antonio, TX site**
*Initial training onsite. 1 day on site/the other 4 remote once training is complete*

· Under the direction of the Complaints Management, the Quality System Specialist II, will manage activities and procedures associated with complaints concerning BD products including reviewing customer complaints 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. 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 as needed.

· The position requires good documentations practices and applicants must maintain in-depth knowledge of Company, Department, and Quality products, processes and policies. Individual will be responsible to interact and communicate with the respective business units, departments, and/or functional groups.

1. 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
  • Follow procedures to ensure timely and accurate review of customer complaints and filing of MDRs with the fDA
  • Ensures compliance with all BD policies and procedures

2. 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.

3. 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.

4. 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 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.

5. 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
  • (Add additional rows as needed)

3. KSA Requirements (Knowledge, Skills, and Abilities)
KSA Minimum Requirements Knowledge

  • 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.

Skills

  • 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

Education/Degree
(e.g. BA or BSc degree in (major) or (#) yrs. relative experience in lieu of a degree)
Certifications (if applicable)

  • Licensed Medical Professional desired such as Registered Nurse (RN), Med Technologist, Biomedical Engineer

Experience (in years)

  • 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 regulations.

For people management position, indicate years of experience (e.g. (#) year’s leadership experience in planning, developing, organizing, directing, managing, and evaluating personnel):
Other: Identify the minimal level of other competencies required for the position:

Job Type: Full-time

Salary: $20.00 - $30.00 per hour

Work Location: One location

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