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Complaint Specialist in Toano, VA at Owens & Minor, Inc.

Date Posted: 5/17/2019

Job Snapshot

Job Description

POSITION SUMMARY

 

Administers, monitors and continuously improves the product complaints process to ensure compliance with government regulations regarding complaint handling/medical device reporting requirements.



ESSENTIAL JOB FUNCTIONS: 

1.      Primary contact and subject matter expert for the company's product complaint handling and medical device reporting.

2.       Enters product complaints into the Complaint Handling system and determines and assigns/routes the investigation to the appropriate department per internal processes.

3.       Communicates with customers to assure complete and accurate complaint files, including complaint details and product information, are created.

4.      Following pre-determined guidelines, decides if the investigation should be escalated/expedited based on the volatile or critical nature of the complaint and business needs.

5.      Collaborates with other functions to ensure accurate, timely and complete complaint evaluation and investigation in compliance with the company's complaint handling process.

6.      Acts as product complaint handling and Medical Device Reporting (MDR) subject matter expert for internal and external audits and inspections.

7.      Reviews product complaint trend data to initiate Corrective and Preventative Action (CAPA) as specified in our company's procedures.

8.      Investigates supplier related complaint issues by:

a.      reviewing Production Quality Records (PQR) and supplied samples, performing inspections of in-house stock;

b.      following up with the customer to provide samples and additional information as appropriate;

c.       submitting the initial complaint information to the supplier and providing all supplied samples as applicable;

d.      coordinating all requests from the supplier to the customer as needed;

e.      follows up with the Supplier for root cause investigation results as appropriate.

9.      Contacts customer(s), distributor(s) and 3PL(s) to have inventory checked, product placed on hold, product returned, and follow up actions completed as necessary.  

10.  Creates and issues Return Goods Authorization (RGA) and shipping documents to the customer, distributor and 3PL for complaint and other Quality issues per the RGA procedure.

11.  Initiates and coordinates customer product replacement requests; supports the communication between Procurement and the Sales Rep when additional sourcing questions and concerns arise; assists with any follow up actions as needed.

12.  Initiates credit requests to Accounting related to complaint issues and completes any follow up actions as needed.

13.  Collects raw data and secondary investigation results entering them into database.  This includes converting terminology and editing as appropriate.

14.  Formalizes complaint investigation for entry into database to ensure appropriate level of detail and to comply with risk analysis and regulatory compliance requirements.

15.  Ensures the distribution and communication of necessary product complaint information and letters as outlined by the Complaint Handling Procedures.

16.  Documents production quality records,  requests Device History Records (DHR), and supports the analysis of DHRs to support product complaint investigations.

17.  Supports labeling regulatory reviews and approvals as needed.

18.  Supports the Quality Assurance Regulatory Affairs (QARA) Non-Sterile tray compliance reviews.

19.  Runs Quality score card reports as required by gathering data and utilizing company Enterprise Resource Program (ERP) system and other software systems.


SUPPLEMENTAL JOB FUNCTIONS:  

1.      Performs additional duties as directed.



Qualifications

EDUCATION & EXPERIENCE REQUIRED:  

1.       Bachelor's degree from four-year College or university required

2.       Two or more years of related experience in Quality Assurance or one year of experience in Medical Device complaint handling required

3.       Or equivalent combination of education and experience

4.       Society for Quality and/or Lean Six Sigma Certification preferred

5.       Training in problem solving tools is preferred (e.g. Process Mapping, Histograms, Failure Mode Effects Analysis, Risk Assessment, Cause & Effect Diagrams, Plan-Do-Check-Act, Pareto Analysis)

KNOWLEDGE SKILLS & ABILITIES:

1.       Advanced understanding and interpretation of domestic and international complaint handling and reporting

2.    Possesses problem-solving, analyzing and critical thinking ability

3.    Able to organize, manage and prioritize multiple tasks in a fast-paced, stressful environment while meeting established deadlines

4.    Possesses a strong work ethic and a proven ability to work independently and make decisions demonstrating good judgment

5.    Demonstrates functional ability to use Microsoft Office Suite to include use of Outlook

6.    Able to learn company software programs such as the ERP system

7.    Adapts to a changing environment and a variety of daily tasks

8.    Possesses excellent attention-to-detail

9.  Has exceptional customer service / interpersonal skills and a strong ability to work cooperatively with people at all levels

10.  Communicates professionally with employees, customers and vendors in person and on the telephone

11.  Work well in a team environment

12.  Processes and safeguards sensitive and confidential information

13.  Operates standard office equipment

ADDITIONAL REQUIREMENTS:  

1.       None



WORKING CONDITIONS AND ENVIRONMENTAL HAZARDS

  1. Inside working conditions.
  2. No environmental hazards indicated for this role.
  3. Mobility is required to allow access to Production clean rooms and the warehouse. 
  4. Requires the ability to withstand varying temperature extremes in the warehouse and to fulfill regularly assigned duties. 
  5. Must comply with company hygiene and gowning requirements as defined in the Department Operating Procedures, 'Gowning Requirements and Basic Hygiene for Warehouse, Assembly, Clean Room and Boxing Areas'.
  6. Must be able to withstand exposure to isopropyl alcohol used for hand cleaning.
  7. Must be able to withstand exposure to latex.

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