e-MUG Engineering Services Pvt. Ltd.
Location: Pune
Experience: 3-6 Years
Employment Type: Full-time
Job Overview
EMUG Engineering Services is looking for a Quality Engineer with experience in Medical Device Quality Management Systems (QMS), regulatory compliance, audits, CAPA, risk management, and design controls.
Roles & Responsibilities
- Implement, maintain, and improve the Medical Device QMS in compliance with ISO 13485, FDA 21 CFR 820, and applicable regulatory requirements.
- Ensure software lifecycle processes comply with IEC 62304.
- Support medical device design and development in accordance with ISO 13485, ISO 14971, and IEC 62304.
- Support New Product Development (NPD) and design control activities.
- Prepare, review, and control QMS documentation, including SOPs, procedures, records, and forms.
- Manage Document Control, Change Control, and Training Records.
- Plan and conduct internal audits and support external audits, including Notified Body and FDA audits.
- Manage CAPA, non-conformances, deviations, and root cause analysis (RCA).
- Support Risk Management activities in accordance with ISO 14971.
- Coordinate Management Review Meetings and prepare reports.
- Ensure compliance across Design Controls, Production, and Quality Control activities.
- Analyze quality metrics, KPIs, and SLAs, including RCA and CAPA.
- Support Verification & Validation (V&V) activities for medical devices and products.
Education & Skills
- Bachelor’s degree in Engineering, Pharmacy, Life Sciences, or an equivalent field.
- 3-6 years of experience in Medical Device QMS.
- Strong knowledge of ISO 13485, ISO 14971, and IEC 62304.
- Experience in audits, CAPA, RCA, documentation, and quality management.
- Good communication and technical documentation skills.
- ISO 13485 Internal/Lead Auditor certification will be an advantage.
- Exposure to Medical Device Design Control documentation.