Remediation Specialist QuEST Global

Job Requirements
• Create/ Update design history file documents such as Requirement documents, Design input / output, Verification & Validation, Traceability & Risk management documents

(DFMEA, PFMEA, UFMEA, PHA, RMP, RMR etc.)
• DHF gap Assessment and remediation for latest medical device standards (FDA 21 CFR Part 820, EU MDR etc)
• Update/ Create process and product qualification documentation includes IQ/OQ/PQ, Test method validation, Gauge R&R & PPAP process.
• Identifying gaps and remediate sterilization and bio compatibility documentation for medical devices.
• Ensure compliance with labeling and packaging regulations, including content, design, and format requirements.
• Understanding and complying with regulatory standards for medical devices including regional regulatory requirements.
• Knowledge of ISO13485 medical device quality management system and ISO 14+71 medical device risk management process.
• Manage the design history file and originate / review the documents in product life cycle management tools like Agile/ Windchill.

Work Experience
• Bachelor’s / Diploma in a related field, such as biomedical engineering, Mechanical Engineering, Electrical and Electronics Engineering or related life science.
• 2-4 years of experience in Medical device industry specialized in product development/design quality/ remediation process
• Excellent communication, with the ability to work effectively with cross-functional teams.
• Strong understanding of technical documentation requirements for medical devices (e.g., design controls, risk management, QMS).

Additional Responsibilities:
• Stay current on industry trends: Attend industry conferences, webinars, and workshops to stay informed about emerging trends, policies, and laws in the medical device industry.
• Collaborate with cross-functional teams: Work closely with other departments, such as quality assurance, manufacturing, and clinical affairs, to ensure a comprehensive understanding of product development and regulatory requirements.