CAPA Specialist / CAPA Quality Engineer

About the Company

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

Position: CAPA Specialist / CAPA Quality Engineer
Location: Washington
Duration: Long Term

Job Overview

We are seeking an experienced CAPA Specialist / CAPA Quality Engineer to support Quality Assurance and Quality Systems activities within the medical device industry. The candidate will lead CAPA investigations, perform root cause analysis, drive corrective and preventive actions, and ensure compliance with FDA and ISO 13485 requirements.

Key Responsibilities

• Lead CAPA investigations from initiation through closure.
• Perform root cause analysis to identify underlying issues.
• Develop and implement corrective and preventive actions (CAPA).
• Work with CAPA owners to drive actions to timely completion.
• Monitor CAPA progress and follow up on open actions.
• Maintain CAPA documentation, investigation records, and reports.
• Support CAPA effectiveness checks and closure activities.
• Ensure compliance with FDA regulations and ISO 13485 requirements.
• Collaborate with Quality Assurance, Quality Systems, and cross-functional teams.
• Support continuous improvement of quality systems and processes.

Required Qualifications

• Experience in CAPA management within the medical device industry.
• Experience leading CAPA investigations from initiation through closure.
• Strong knowledge of root cause analysis and corrective/preventive actions.
• Experience working with CAPA owners and tracking actions to completion.
• Knowledge of medical device quality systems.
• Understanding of FDA quality requirements and ISO 13485.
• Experience with CAPA documentation, investigation reports, and effectiveness checks.
• Strong analytical, problem-solving, communication, and organizational skills.
• Ability to manage multiple CAPAs and work with cross-functional teams.

How to Apply

Apply Now: Submit your updated resume to Stark Pharma Solutions Inc. for consideration.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.