Quality Assurance Specialist

Responsibilities

• Assess device related complaints for medical device reporting
  
  

requirements. Compile and submit reportable events to relevant

regulatory authorities in a timely manner. Handle recalls and field

actions, if required. Review and approve complaint files.

• Maintain eQMS system and all document control activities
• Support external audits (e.g. customer, corporate, notified body)
• Respond to compliance-related customer inquiries in a timely
  
  

manner, including but not limited to preparing certificates of origin

and other regulatory documents, and supplier questionnaires

• Perform change control activities for all document types, ensuring
  
  

that the document control program meets all applicable standards

and procedures and meets the required pace of business partners

• Support the execution of the site's training program
• Maintain Quality records according to Exelint International policies
  
  

and procedures

• Support timely delivery of products to customers with lot release
  
  

and preparation of certificates of analysis

• Support external regulatory agency audits, providing
  
  

input to minimize potential for findings of non-compliance.

• Participate in post-market surveillance activities for licensed
  
  

products.

• Assist in fulfilling requirements under the EU MDR 2017/745
  
  

transition.

• Maintain QMS procedures related to regulatory responsibilities,
  
  

product licensing, and regulatory reporting.

• Lead projects as needed by the quality department and
  
  

participate in design control projects

• Participate in internal audit program.
• Other projects will be assigned as various business needs arise