US Quality Compliance Specialist (Homebased, Nighshift)

Job Description

About Us:
Outsourced. ph is a leading ISO-certified Philippines offshore outsourcing company that provides dedicated remote staff to some of the world's leading international companies. Outsourced is recognized as one of the Best Places to Work and has achieved Great Place to Work Certification. We are committed to providing a positive and supportive work environment where all staff can thrive. As an Outsourced staff member, you will enjoy a fun and friendly working environment, competitive salaries, opportunities for growth and development, work-life balance, and the chance to share your passion with a team of over 1,000 talented professionals

Key Responsibilities:
Quality Management System

• Support in the overall implementation of the company's quality system in conformance with MDSAP
• Maintain and improve QMS documentation including but not limited to SOPs, WIs, forms, etc.
• Manage the document control lifecycle: creation, review, approval, distribution and periodic review initiation
• Coordinate change control activities including design changes, software updates, system, product and process changes.
• Coordinate with the Multi-Disciplinary Team in all risk management activities.
• Support in the preparation for external audits (2nd and 3rd party).
• Take on other responsibilities related to QMS as may be assigned by the direct supervisor.

 
Internal Audit Activities

• Prepare the internal audit program and audit plan.
• Coordinate internal audits across QMS processes.
• Draft audit reports, classify findings and track CAPAs.
• Participate in audit activities.

 
CAPA and Complaints Management

• Administer the CAPA system, support in the RCA process including investigation, implementation action follow-up, effectiveness checks and trend analysis.
• Monitor the implementation of complaint handling, coordinate reportability determination and maintain complaint files.
• Track nonconformity reports, deviations and audit findings and submit data for trend analysis.

 
Qualifications:

• Bachelor's degree in Life Sciences, Engineering or a related field.
• 3+ years of QA/QMS experience in a medical device manufacturing environment. Regulatory experience is a plus.
• Demonstrated working knowledge of ISO 13485:2016, ISO 14971:2019 and root cause analysis tools. Familiarity with MDSAP audit program is a plus.
• Strong technical writing skills: ability to author and review SOPs, risk documents, and regulatory submissions.

 Work Location

• Homebased
• Tuesday–Saturday, 3:00 AM – 12:00 PM (PHT)
• Should have strong internet connection (minimum of 20 mbps)
• Should have own Laptop/PC (minimum of i5 8GB RAM)
   

Note: As part of our recruitment process, we conduct a background check on all hired candidates. Please ensure that all required documents are prepared and submitted promptly.
 
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