Find your new career TODAY!

Quality Head / Sr. QA and Regulatory Compliance Manager

Date Posted
10th November 2017
Quality Assurance
Job Type
San Juan, PR
Not Disclosed

Job Summary

Our client in the San Juan Metro area is in search of a Quality Head / Sr. QA and Regulatory Compliance Manager.

Job Description


  • Quality System implementation and monitoring
  • Compliance External Audits (FDA - ISO - Japan (PAL)
  • Documentation Control
  • Design Control (Advice on Regulatory)
  • Production and Process Change Regulatory Requirements
  • CAPA Approval
  • Validation System oversight
  • Provide updated into Management Review
  • Provide Guidance in Regulatory Decisions
  • Provide support on documentation of Regulatory Affairs
  • Approving Quality Feedback
  • Approving of Complaint Investigation
  • Approving nonconformance material disposition
  • Monitoring Unit Performance
  • People Development
  • Providing Capabilities to Work Unit
  • Create and oversight of the site Quality Culture
  • Departmental Budget Creation
  • Payroll Administration/ Kronos
  • Vacations & Overtime Administration for Exempts
  • BPCS Purchases Requisition Approval



  • Demonstrated knowledge and application experience of the FDA Quality System Regulation (21 CFR Part 820) and related regulations, as well as knowledge in all major manufacturing processes and support systems
  • Demonstrated excellent communication skills (oral and written) with all levels of management in both English and Spanish languages
  • Computer literate with a working knowledge of software programs such as Microsoft Office (Word, PowerPoint, Excel)
  • Excellent organization skills
  • Ability to handle, organizes and follow up multiple priorities
  • Needs to have high analytical capacity and level of professionalism and judgment to resolve problems
  • Must be a team player
  • Must be able to work under pressure
  • Generally, works in a closed environment, in office conditions, with moderate level of noise and controllable changes of temperature
  • Needs to stand, walk and may be seated for a long period of time
  • Uses hands to feel, handle and reach
  • Performs light physical effort with little exposure to adverse conditions
  • Could be required to travel
  • Works with a personal computer and programs to prepare documents or reports
  • A minimum of eight years of experience in Quality/Regulatory Compliance in a regulated industry, preferable medical devices
  • Experience supervising exempt and non-exempt personnel.
  • Bachelor degree in Sciences, Engineering or related field or equivalent experience


Quality System Responsibilities:

  • Complies with the Quality System Regulation (QSR)
  • Executes job responsibilities as established in the Standard Operating Procedures (SOP)
  • Follows the documentation procedures


Safety & Occupational Health Responsibilities

  • Complies with Safety and Occupational Health Policy and procedures
  • Complies with Hazardous Communication program
  • Notifies immediately all accidents or incidents occurred in work area
  • Complies with the usage, inspection and maintenance of the personal protective equipment required, if applicable
  • Promotes and maintains a safe working area and notifies any condition he/she may think might cause an accident
  • Participates in the activities of the Safety and Occupational Health Program as requested.

Upload a New Document for this application

Password* Confirm Password*
First Name* Last Name*
Home Location*:
How did you find us?*
Cover Letter
By submitting this form you agree to our terms of use