Location: Aibonito, PR
Duration: 4 months
Salary: $20–$26 per hour

Job Purpose:
Incumbent will be responsible for ensuring compliance with the Quality System Regulation regarding Quality and Manufacturing Processes and methods. Supervises the internal audits activities to ensure compliance across the site. Supervises the activities related to the Management Review process, Site Master File, Observation Certification Program, and Readiness Program to ensure these are completed in a timely manner. Responsible for the SiteReadiness program to ensure areas are prepared for regulatory inspection. Ensures the sites KPIs are tracked and submitted on time for Management Review presentation. Performs APQRs and ensures these are completed on time. Provides support to the Internal Audits process.

Responsibilities:

• Responsible for the oversight of Internal Audits related activities (including corrective actions, preventiveactions, effectiveness checks, and Observation Certification Program) to ensure timely completion andclosure as per Global and local requirements.
• Ensures the Readiness program is maintained as per Global and local requirements. Provides oversight ofthese activities to ensure timely completion.
• Maintain updated the Aibonito Facility Inspection Readiness Plan.
• Maintain updated the Aibonito Site Master File.
• Ensures the Observation Certification Program is executed as per requirements, preventive actions areidentified, and any gaps are identified and addressed until resolution.
• Maintains the on-time data gathering for the site Key Performance Indicators (KPIs) and drives improvementthrough the identification of preventive actions and improvement activities.
• Ensures the timely completion of the Management Review presentation and ensure presented data is alignedwith global and local requirements.
• Performs the Annual Product Quality Report (APQR) final reports and ensures these are uploaded in TCUsystem for timely approval.
• Provides support to the Internal Audits program as an internal auditor.
• Perform special tasks or assignments as required.
• Assure all documentation performed in the area is complete, accurate, and in compliance with theprocedures, specifications and regulations.
• Promote a zero-harm work place and assure that required EHS resources are available and that allapplicable EHS practices and rules are being followed.
• Observe confidentiality and data privacy rules at all time.
• Be a facilitator of Manufacturing and Quality Improvement projects.
• Keep in compliance with GMP, FDA, ISO requirements, and other Regulatory Agencies.
• Submit changes (improvements and/or modifications) to specifications and Standard Operating Procedures.
• Responsible for review changes in specifications and SOP's under CDR system.
• Provide support and/or manage non-conformance investigations (NCR, CAPA, etc.) and NCRs related to theInternal Audits area.
• Interact under minimal supervision with various Local and Divisional function groups.

Qualifications:

• Bachelor's degree in Science or Engineering. Other bachelors degrees may be considered if it is commensurate with experience in Quality Assurance, Quality Control or Documentation Center.
• At least 5 years of experience in Quality in a Medical Devices or similar industries.
• Excellent communication. Knowledge in Statistics preferred.
• Computer software knowledge in: Excell, Power Point, Word or similar. 

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 20.00/hr.