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Quality System Specialist II
Ref No.: 18-27651
Location: San Antonio, Texas
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 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.
  • 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 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
  • 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.

  • BA or BS degree preferred and/or combination of education and relative experience in lieu of a degree
  • Diabetes Knowledge a Plus
  • Minimum 1+ years of experience with Medical terminology, Nursing, Clinical or laboratory knowledge and familiarity with products
  • Minimum 2+ years of experience in the complaint handling, medical device industry, customer relations, complaint trending, FDA/ISO regulations.