Quality Head / Sr. QA and Regulatory Compliance Manager

Published: November 8, 2017
Job Type
Category
Job Code
22724
Years of Experience
8
Salary
To be discussed.
Travel
No
Education
Bachelor’s Degree
Contact
Ilia Cordero
Contact Email
icordero@careersincpr.com

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

Requirements

  • 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.
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