Quality Assurance Engineer
- Career Ahead
- 28 Positions
- Noida, Gurugram
- 9 months ago
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Job Description
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Update Device Master Records (DMRs) in accordance with customer and regulatory requirements.
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Maintain and update Raw Material Master Specifications (RMMS) as new materials are introduced into the Quality System.
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Assist in updating Technical Files as per regulatory and documentation requirements.
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Manage Customer Complaint Documentation from receipt to closure, and maintain an accurate complaint log.
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Maintain Quality Management System (QMS) documentation aligned with standards/guidelines such as:
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ISO 13485 / MDSAP
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21 CFR 820
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EU MDR 2017/745
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Ministry of Health (MoH) CIS Countries
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Support planning and documentation of Management Review Meetings (MRM) every six months and ensure compliance.
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Prepare and compile documentation such as:
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Machine Manuals
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Standard Operating Procedures (SOPs)
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Work Instructions (WIs)
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Quality Formats
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Assist in NC (Non-Conformance) and CAPA (Corrective and Preventive Actions) closures from internal and external audits.
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Contribute to shop floor QA activities to enhance understanding of both existing and new products.
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Support internal audit documentation and execution.
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Conduct Quality Training on the shop floor as per the training calendar and maintain training records.
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Maintain and manage external documents shared with customers.
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Ensure timely calibration of instruments/equipment, and compile calibration certificates in collaboration with Quality Control.
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Assist in preparation of Design Dossiers.
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Bachelor's or Masters degree in Pharmacy or Engineering (B.Tech / B. Pharma / M. Pharma).
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2-9 years of core Quality Assurance experience.
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Strong understanding of Quality Management Systems (QMS) and documentation processes.
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Proficient in MS Office; ability to work on Word, Excel, and PowerPoint.
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Excellent communication and documentation skills.
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Prior experience in the Medical Device industry is MANDATORY.
Dear candidate,
Position: Quality Assurance Executive / Senior Executive
Experience: 2-9 Years
Industry: Medical Device (Mandatory)
Qualification: B.Tech / B. Pharma / M. Pharma
Location: Noida
Functional Responsibilities:
Required Competencies:
Interested candidates can email their updated CV to:
hidden_email
Thanks & Regards
Employement Category:
Employement Type: Full timeIndustry: Medical / HealthcareRole Category: Quality (QA-QC)Functional Area: Not SpecifiedRole/Responsibilies: Quality Assurance EngineerContact Details:
Company: Career AheadLocation(s): Noida, Gurugram
Keyskills: auditing standards iso 13485 regulatory affairs qa quality assurance capa
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We are a New Delhi, India based company with a sales presence in Jacksonville, FL, USA offering a range of services in Software Solutions, Digital Marketing and Business Services. We specialize in working with businesses and devise solutions to enable them reach their business objectives. We work ...
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