Product Surveillance Associate

Location: Sturtevant

Job Description:

The Product Surveillance Specialist V performs day-to-day tasks and provides technical data assessment of post-market events and can support the Quality Department with Quality System activities including Change Control and Client/CAPA. This position plays an integral role in maintaining compliance with global regulations. The Product Surveillance Specialist V works with minimal supervision and requires a high degree of interaction with customers, health care professionals, global government agencies, and Global Merz employees at all levels within the organization.

Work Environment:
Onsite Required
Overtime limited
Must be able to pass vision testing requirements at 20/20 near acuity vision (with or without corrective eyewear).

Key Responsibilities:

• Independently field inquiries received by phone, electronic or verbal correspondence and determine if it qualifies as a complaint; document reported issues according to applicable SOP(s).

• Provide technical support and remote troubleshooting guidance as needed.

• Independently review associated records, 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.

• Independently 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 moderate problems.

• Conduct statistical analysis of complaint trends.

• Support training program by training users on the complaint process and tools used to assess and investigate complaints.

Process Improvement Initiatives:

• Supports and may identify operational changes to improve efficiencies in all aspects of complaint handling.

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

• Update internal operating procedures and specifications through the Document Change process.

Compliance Initiatives:

• Support and participate in internal quality system audits. Support external quality system audits.

• Evaluate complaints and determine if the submission of a Medical Device Report (MDR) or other Vigilance Report is required.

• Support submitting MDRs and Vigilance Reports according to regulatory timelines.

Education (required):
High School Diploma with 4 years of experience OR Associate's Degree with 2 years of experience OR Bachelor's Degree

Work Experience:

Medical or Surgical Office Experience (preferred)
Customer Service Experience (preferred)

Knowledge, Skills, Abilities:

• 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.

• Highly organized with attention to detail.

• Strong ability to prioritize and manage multiple records/reports simultaneously.

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

• Effective communication skills including written and verbal.

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

• Proficient in Microsoft Office Suite.