Complaint Determination Specialist

Job Title: Complaint Determination Associate

Location: Onsite

Employment Type: Full-Time

The Complaint Determination Associate supports the Global Product Monitoring team by ensuring compliant decisions are made regarding medical device complaints. This role involves reviewing, categorizing, and reassessing inquiry records in line with global regulations. The associate works under the guidance of the Team Lead, Complaint Determination, to uphold quality and compliance standards while facilitating effective complaint handling.

1. 
   

   Complaint Determination Process Execution:

   
   
   
   
   • Review inquiry records to determine if they meet the definition of a medical device complaint.
   • Assign appropriate categories to cases identified as complaints to streamline subsequent processing.
   • Categorize non-complaint feedback for accurate trending and reporting activities.
   • Reassess records when new information becomes available.
   
   
   
   
2. 
   

   Compliance and Documentation:

   
   
   
   
   • Follow established global regulations and internal processes for complaint determination.
   • Ensure accurate and complete records in compliance with QSR and ISO 13485 standards.
   
   
   
   
3. 
   

   Collaboration and Additional Duties:

   
   
   
   
   • Collaborate with team members to resolve interpersonal conflicts and maintain a cohesive work environment.
   • Take on other complaint handling responsibilities as assigned.
   
   
   
   

• Solid understanding of QSR and/or ISO 13485 standards (preferred).
• Familiarity with medical device complaint handling processes (preferred).
• Proficiency in Microsoft Office tools.
• Working knowledge of TrackWise and SalesForce CRM (preferred).
• Strong attention to detail with the ability to organize and prioritize tasks.
• Effective verbal and written communication skills.
• Ability to maintain accurate records and work in a team-oriented environment.

• Ability to resolve team interpersonal conflicts.
• Self-motivated and capable of managing multiple priorities with minimal supervision.

• Experience in medical device complaint handling or a related field is preferred.

This role offers an excellent opportunity for individuals passionate about quality and compliance in the medical device industry. Join a dynamic team dedicated to upholding the highest standards of complaint handling and product monitoring.

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With company roots going back over 30 years, Advantage Technical is an engineering and information technology services company and a national leader in the provision of technical resources today. These services include Staff Augmentation, Direct Placement, Project Resourcing and Outsourcing - delivered from 40 key market locations, by over 3500 specialized contractors, to over 500 clients across North America. Advantage Technical is a Best of Staffing Diamond Award winner for both Clients and Talent. For more information about the industries and services offered by Advantage Technical, please visit AdvantageTechnical.com.

Advantage Technical is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact your local branch. Advantage Technical is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.