Quality Compliant Specialist

Company: Joul--
Location: Exton
Posted on: March 20, 2025

Job Description:

Job Title: Quality Complaint Specialist

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Location: Exton, PA
Hours/Schedule: (Hybrid) 3 days onsite & 2 remote; 8-9 to 5pm
Type: contract

Overview
Leading consumer goods company looking for an experienced Quality Compliant Specialist. Ideal candidates should have at least 2 years of regulatory experience preferably within a medical device company.

Responsibilities Support the complaint management system, including the continual monitoring, assessment of feedback, and evaluation of effectiveness of complaints.
Intake, evaluate, document, disseminate, and organize product complaint information.
Review internal documentation and quality records related to complaints to support investigation and evaluate trending.
Review and close complaint files confirming associated regulatory reporting, action assignment, customer communication, and trending information.
Perform customer service duties as it relates to customer complaints and associated materials, including facilitating returned goods authorizations and obtaining additional customer information on complaints.
Work on occasion in a warehouse or cleanroom setting following protective procedural requirements and comply with all safety requirements, including posted placards, SOPs and the Safety Manual.
Report any observed unsafe equipment, condition or practice immediately to a supervisor, management, or member of the Safety Committee.
Adhere to Quality System procedures, ISO 13485, 21 CFR part 820 and current applicable regulatory requirements.
Complete other tasks as assigned by the Quality Engineering Manager.


Requirements
Knowledge and Educational Level Bachelor's degree in a scientific discipline is preferred, or equivalent undergraduate or professional experience.


Required Level of Experience Minimum 2 years of experience in medical device Complaint Management, or Quality Assurance at an FDA-Regulated, Medical Device, or Pharmaceutical related industry.
Excellent written and verbal communication skills, including writing, editing and proofing skills.
Proven track record of meticulous attention to detail.
Strong communication and interpersonal skills, with the ability to collaborate effectively.
Demonstrated ability to multi-task resulting in positive outcome for each task assigned or self-generated.
Experience with or ISO 13485 and 21 CFR 820 preferred.
Proficient in MS Office software including Word, Excel, and Outlook.
Experience with Quality Product Lifecycle Management systems preferred.


Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.


Ref: #558-Scientific

Keywords: Joul--, Lower Merion , Quality Compliant Specialist, Other , Exton, Pennsylvania