Job Description
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.
• 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.
💡 Quick Summary
Seeking a career-building opportunity? The Remediation Specialist QuEST Global position is now open for candidates interested in the Labour/Helper Jobs sector. This role in Pune offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Labour/Helper Jobs is a plus.