Job Description

Job Title: Product Surveillance Quality Specialist (Medical Device)

Pay:  $22.00hour
Benefits:  Eligible to Enroll in Medical Benefits

Job Overview:  The Product Surveillance Quality Specialist performs day-to-day tasks and provides technical data assessment of post-market events. This position plays an integral role in maintaining compliance with global regulations. The Product Surveillance Specialist IV works with moderate supervision and requires a high degree of interaction with customers, health care professionals, and Global employees at all levels within the organization.
Essential Duties and Responsibilities: 

• Field inquiries received by phone, electronic or verbal correspondence and document reported complaints according to applicable SOP(s).

• Provide technical support and remote troubleshooting guidance as needed.

• Review associated records; provide technical guidance, and contact users and customers to collect information on the treatment, product performance, functionality, etc.

• Conduct periodic follow-up to close complaints in a timely manner.   

• Manage customer relationship and expectations during the course of the complaint investigation.

• Complete investigations, which may include execution or coordination of product returns and subsequent evaluations, review of manufacturing records and ensuring proper approvals are obtained as part of closure. 

• Develop solutions to a variety of basic problems.

• Support statistical analysis of complaint trends.

• Support operational changes to improve efficiencies in all aspects of complaint handling.

• Evaluate complaints and determine if the submission of a Medical Device Report (MDR) or other Vigilance Report is required.  Additional responsibilities may include submitting MDRs and Vigilance Reports according to regulatory timelines.

• Support investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analyzing the data for the reasons of Quality Improvement and reporting.

• Support internal and external quality system audits.

• Recommend operational changes to improve efficiencies in all aspects of complaint handling. 

• Maintain awareness of changes to global regulatory requirements related to complaint handling and adverse event reporting.

Requirements:

• BS in a Physical Science or Engineering or Equivalent Experience.

• Experience in Quality Assurance and/or other regulated industry or similar experience required  

• Strong technical writing and general problem-solving skills required
  
  OR

• High School Diploma with 3 years of experience, or Associate’s Degree with 1 year of experience.

• Customer Service or similar experience working with people.

• Medical or Surgical Office experience a plus.

• Experience with Microsoft Office Suite.

• Familiar with ISO 13485 Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.

• Basic medical and/or scientific terminology.

• Organized with great attention to detail.

• Able to prioritize and manage multiple records/reports simultaneously.

• Professional phone etiquette with the ability to appropriately handle sensitive information.

• Ability to work with company staff and communicate effectively throughout the organization.

• 20/20 Near Acuity Vision.