Quality Engineer - Medical Devices
e-MUG Engineering Services Pvt Ltd · Pune · onsite · Posted 27d ago
Undisclosed3–6 yrsfulltimeSourced from
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About this role
Location: Pune
Experience: 3-6 Years
Employment Type: Full-time
Job Overview Experience: 3-6 Years
Employment Type: Full-time
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 (VV) activities for medical devices and products.
- 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 .
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
Sourced from naukri
Skills
Quality EngineerNPDCfrISO 13485auditsCAPAChange ControlRoot Cause AnalysisPharmacyRegulatory ComplianceQuality ControlNew Product DevelopmentMedical DevicesRisk ManagementcomplianceLife Sciencesquality management
About e-MUG Engineering Services Pvt Ltd
e-MUG Engineering Services Pvt Ltd
Engineering & Construction
175
employees
2001
25 years old
Hyderabad / Secunderabad, Telangana
IN
₹5.2L PA avg
Avg at e-MUG Engineering Services Pvt Ltd
About
e-mug Technologies offers engineering services with a focus on continuous improvement and innovation, catering to multiple industrial sectors globally.
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