Quality & Regulatory Manager
Job Type
Full-time
Description

  

  • Management Representative for Quality Management System.
  • Oversee and manage compliance of regulations that pertain to Design and Manufacturing of medical devices (FDA, ISO 13485, MDSAP, RoHS.) Stay current with new and changing regulations. 
  • Provide guidance and interpretation for additional regulations such as IEC 62304, ISO 14971 as needed.
  • Provide Quality support to manufacturing, engineering, and support operations through the administration, collection, analysis of data, and the industry standards associated with each product line.
  • Ensure QMS support system, including IT infrastructure, tools, software and systems are compliant with industry regulations and standard practices. 
  • Manage and lead FDA, ISO, Customer, Safety Agencies, and other third party audits.
  • Manage internal audit and layered process audit programs.
  • CAPA, advisory notice and complaint management.
  • Oversight of Validation, Change Control, and Temporary Deviation activity.
  • Manage weekly/monthly quality metrics.
  • Manage CAT/PPT meetings.
  • Prepare and lead Quarterly Management Reviews.  
  • Oversees Quality related training to appropriate personnel.
  • Manage and develop Quality department employees’ job performance.
Requirements
  •  Bachelor’s degree in engineering or relevant field.
  • 5 years of experience  in a relevant Quality/Regulatory position in the medical device industry or equivalent experience.
  • Expertise in medical device laws and regulations (ISO 13485 and FDA CFR).
  • Good working knowledge of quality statistical techniques.
  • Expertise in software programs such as Windows Word, Excel, PowerPoint. 
  • Strong communication and training skills.