QA/QC Engineer

10 hours ago

Bhopal, Madhya Pradesh, India Intense Medical & Dental System Pvt. Ltd. Full time ₹ 4,23,831 per year

Job Description – QA & QC Engineer (Medical Devices)Position Summary

The QA & QC Engineer is responsible for ensuring that all medical devices meet quality standards, regulatory requirements, and organizational policies. The role involves implementing quality systems, performing inspections, conducting audits, and supporting regulatory submissions to ensure safe and effective products are delivered to the market.

Key Responsibilities

  • Quality Assurance
  • Develop, implement, and maintain Quality Management Systems (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable standards.
  • Conduct internal audits, CAPA (Corrective & Preventive Action), and risk assessments to ensure ongoing compliance.
  • Monitor production processes and verify adherence to SOPs, specifications, and quality standards.
  • Quality Control
  • Perform in-process inspections, final product testing, and release of products.
  • Review and approve batch records, test reports, and other QC documentation.
  • Manage calibration and preventive maintenance schedules for testing and measuring instruments.
  • Investigate non-conformities and implement corrective actions.
  • Regulatory Compliance
  • Ensure compliance with national and international medical device regulations (FDA, CDSCO, CE, ISO).
  • Support preparation of regulatory submissions (510(k), PMA, CE Marking, etc.).
  • Communicate with regulatory authorities to resolve compliance issues.
  • Process Improvement
  • Identify areas of process improvement to enhance product quality and operational efficiency.
  • Implement Lean Six Sigma/continuous improvement methodologies to reduce defects and improve productivity.
  • Supplier Quality Management
  • Conduct supplier audits and ensure raw material/component quality.
  • Collaborate with vendors for corrective actions and quality improvement initiatives.
  • Documentation & Reporting
  • Prepare and maintain technical files, Device Master Records (DMR), and Device History Records (DHR).
  • Maintain up-to-date documentation to support internal audits, external inspections, and certifications.
  • Generate quality reports and present trends to management for decision-making.

Required Skills & Knowledge

  • Strong understanding of QA/QC principles in the medical device industry.
  • Knowledge of ISO 13485, ISO 14971, GMP, and FDA 21 CFR Part 820.
  • Hands-on experience with quality audits, validation, and verification processes.
  • Familiarity with regulatory submissions and compliance requirements.
  • Excellent documentation, analytical, and problem-solving skills.
  • Ability to train and guide cross-functional teams on quality and compliance.
  • Mob No

Job Types: Full-time, Permanent

Pay: ₹15, ₹35,189.82 per month

Benefits:

  • Cell phone reimbursement
  • Health insurance

Work Location: In person

Speak with the employer

  • Senior QA Engineer

    9 hours ago

    Bhopal, Madhya Pradesh, India Triotech Bizserve Full time US$ 90,000 - US$ 1,20,000 per year

    Company DescriptionWe suggest you enter details here.Role DescriptionThis is a full-time on-site role for a Senior QA Engineer, located in Bhopal. The Senior QA Engineer will be responsible for developing and executing test plans, identifying and documenting bugs, collaborating with development teams to resolve issues, and ensuring the quality and...

  • QA QC Engineer

    8 hours ago

    Bhopal, Madhya Pradesh, India Intense Medical Dental System Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Responsible for ensuring medical devices meet quality standards and regulatory compliance through Quality Management Systems (ISO 13485, FDA 21 CFR Part 820), audits, inspections, and process improvements. Quality Control: Perform in-process & final

  • Chemist Field Operations CBM Shahdol

    8 hours ago

    Bhopal, Madhya Pradesh, India Reliance Industries Limited Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Interested candidates, kindly mail to Main Purpose: Chemist Field Operations is responsible for sample collection, preservation, and laboratory analysis of natural gas, water, and specialty chemicals. Ensures compliance with international standards, equipment calibration, and QA/QC implementation. Manages lab inventory, documentation, and regulatory audits...

  • Xpertz Holidays

    4 weeks ago

    Bhopal, Madhya Pradesh, India Xpert Conexions Full time

    Job Description :1. The Automation QE/SDET Engineer is primarily responsible to establish and maintain quality standards for the set of applications built by the team.2. Develop and execute a comprehensive test strategy, including manual and automated testing, to ensure the platform meets high quality standards.3. Drive test automation efforts, utilizing...

  • Quality Excellence Leader

    5 days ago

    Bhopal, Madhya Pradesh, India beBeeQuality Full time ₹ 18,27,200 - ₹ 24,44,000

    Quality Assurance Manager RoleThis position is responsible for leading and overseeing the quality assurance and control functions across all manufacturing stages.Key Responsibilities:Direct and manage the Quality Assurance and Control (QA/QC) functions across all manufacturing stages – raw material inspection, in-process quality, and final product...

  • Chief Engineer

    2 days ago

    Bhopal, Madhya Pradesh, India Agrawal Ecomines Pvt Ltd Full time

    About the RoleWe're hiring a Chief Engineer to lead the engineering, commissioning, and operations of our biofuel/biogas facility. You will own the plant from design handover → commissioning → steady operations, ensuring safety, reliability, and top-quartile performance.Primary Focus (Must-Have)- Plant Setup (Greenfield/Brownfield): End-to-end...

  • Regulatory Affairs Specialist

    8 hours ago

    Bhopal, Madhya Pradesh, India Intense Medical & Dental System Pvt. Ltd. Full time ₹ 419 per year

    OverviewDevelop, implement, and maintain Quality Management Systems (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable standards.Conduct internal audits, CAPA (Corrective & Preventive Action), and risk assessments to ensure ongoing compliance.Monitor production processes and verify adherence to SOPs, specifications, and quality...

  • Production Manager

    6 days ago

    Bhopal, Madhya Pradesh, India Krishna Engineering Company Full time ₹ 9,00,000 - ₹ 12,00,000 per year

    Department: Manufacturing / Operations Reports To: Plant Head / Director of Operations Role Summary The Production Manager oversees all aspects of metal fabrication operations, ensuring efficient workflow, quality output, and timely delivery. This role demands hands-on leadership, technical expertise, and strategic planning to meet production targets while...

  • Search Engine Optimization Analyst

    8 hours ago

    Bhopal, Madhya Pradesh, India Vista IT Solutions Pvt. Ltd. (VITSPL) Full time US$ 60,000 - US$ 80,000 per year

    Company DescriptionVista IT Solutions Pvt. Ltd. (VITSPL) is a Software, Web/Mobile development, and Systems Integration company, primarily serving the United States market. With over 14 years of experience in industries such as Healthcare, Transit, Finance, and Auto dealerships, VITSPL offers a wide array of IT solutions including Enterprise Solutions, UI-UX...

  • Site Quality Head

    24 hours ago

    Bhopal, Madhya Pradesh, India Symbiotec Pharmalab Pvt. Ltd. Full time

    Job Responsibility:1. To ensure preparation, review and approval of all procedures, in line with the regulatory guidelines/ expectations, identify the gaps and update the procedure. The master documents of the site like VMP, SMF, APQR, QSP, etc. are to be ensured for such compliances from time to time.2. To handle the day today changes, deviations,...