Quality Assurance Specialist

Quality System Specialist – Complaint Handling & Document Control | Medical Devices

Location:
Paris, Île-de-France, France (Hybrid)

Travel:
Limited, occasional audit support

Company Type:
Established medical device manufacturer with a strong Quality and Regulatory foundation.

We are partnered with a rapidly growing medtech organisation in France seeking an experienced Quality System Specialist to support and strengthen its Quality and Regulatory function. This role blends ownership of complaint handling activities with hands on responsibility for document control within a mature Quality Management System.

Key Responsibilities

Complaint Handling

• Manage the relationship and output of a third party complaint handling provider
• Receive, assess and process customer complaints with accuracy and timeliness
• Liaise with Sales, Regulatory Affairs, Quality Assurance, Clinical Affairs and Engineering to gather essential details for complaint investigations
• Communicate with healthcare professionals to obtain clinical context and supporting information
• Review manufacturing investigation reports and provide structured feedback
• Support receipt and evaluation of returned goods
• Document regulatory reportability decisions and ensure alignment with applicable regulations
• Perform complaint investigations, complete root cause analysis and close files appropriately
• Contribute to audit and inspection readiness activities
• Participate in CAPA activities and assist in determining preventive actions
• Support post market surveillance reporting and trending
• Produce metrics and trend analyses to identify complaint patterns
• Participate in cross functional projects and continuous improvement activities

Document Control

• Maintain and manage controlled QMS documentation including manuals, procedures and quality plans
• Review documents for accuracy, completeness and compliance
• Coordinate with internal teams to prepare audit documentation packages
• Support development and improvement of quality procedures and policies
• Train and guide staff on document control processes and quality system requirements
• Participate in internal and external audits and ensure documentation readiness
• Identify opportunities to streamline document control processes and implement improvements
• Maintain awareness of industry standards and regulatory updates and keep the standards library current
• Generate documentation related metrics for management

Additional Quality Support

• Contribute to training administration, supplier management, change control, risk management, internal and external auditing and management review activities
• Support other Quality and Regulatory tasks as assigned

Candidate Profile

• Minimum of
  three years
  of experience in medical device quality assurance
• Hands on experience in complaint handling within a regulated environment
• Practical document control experience within an
  ISO 13485
  compliant QMS
• Strong understanding of
  EU MDR
  ,
  ISO 13485
  ,
  ISO 14971
  and
  21 CFR 820
• Exceptional attention to detail and excellent organisational skills
• Fluent in English

Preferred:

• Bachelor's degree
  in a
  scientific
  ,
  technical
  or
  business discipline
• Proficiency in MS Office and data management tools
• Familiarity with quality tools and structured problem solving methods
• Auditor training or relevant certification

Why This Opportunity Stands Out

• High impact role supporting both complaint handling and document control
• Opportunity to contribute across core elements of the Quality Management System
• Exposure to cross functional collaboration and audit readiness activities
• Stable environment with a strong commitment to regulatory compliance
• Career development potential across Quality Systems, CAPA, auditing and supplier quality