Talent.com
Quality Control Executive

Quality Control Executive

Merilvapi, gujarat, in
2 days ago
Job description

Job Title :

Quality Control Executive – Radiology & Imaging Systems (X-Ray / C-Arm / DR / CT)

Department :

Quality Assurance – Radiology Division

Location : Vapi, Gujarat

Reports To :

Manager / Senior Manager – Quality Assurance

Job Purpose :

To ensure product and process compliance in the manufacturing of radiology and imaging systems including X-Ray, C-Arm, Digital Radiography (DR), and CT equipment , by validating product quality, managing documentation, and supporting audits as per ISO 13485, BIS, and regulatory requirements.

Key Responsibilities :

1. Product Quality Validation

  • Validate the quality and performance of X-Ray, C-Arm, DR, and CT assemblies during in-process and final inspection stages.
  • Ensure all products meet design, safety, and performance specifications as per ISO 13485, BIS 13450, and IEC 60601 standards.
  • Review and approve quality control data, test results, and inspection reports before product release.
  • Coordinate with the Production and QC Testing teams to ensure timely resolution of non-conformities.

2. Process Validation and Documentation

  • Prepare, execute, and maintain documentation for process validation, equipment qualification (IQ / OQ / PQ), and design verification activities.
  • Maintain and update Device History Records (DHR) and Device Master Records (DMR) as per ISO 13485 requirements.
  • Review and control documents including SOPs, Work Instructions, Quality Plans, and Validation Protocols.
  • Ensure traceability and proper control of documents across all production and quality processes.
  • 3. Internal Audits and Compliance

  • Plan and conduct internal quality audits to verify compliance with ISO 13485, GMP, and regulatory requirements.
  • Identify non-conformities, issue audit findings, and ensure timely implementation of Corrective and Preventive Actions (CAPA).
  • Support external audits conducted by certification bodies, notified agencies, or regulatory authorities.
  • Promote awareness of quality standards and support continuous improvement initiatives across the Radiology Division.
  • 4. Cross-Functional Coordination

  • Collaborate with Design, Production, QC, and Regulatory Affairs teams to ensure alignment on quality objectives.
  • Participate in change control, risk management, and product lifecycle reviews to ensure regulatory compliance.
  • Provide training and guidance to production and testing teams on quality system requirements and documentation practices.
  • Qualifications and Experience :

  • B.E. / B.Tech / Diploma in Electronics, Biomedical.
  • 3–5 years (or more) of experience in Quality Assurance, Validation, or Compliance within medical device or imaging equipment manufacturing.
  • Strong understanding of ISO 13485, ISO 14971, GMP, and IEC 60601 standards.
  • Experience with X-Ray, C-Arm, DR, or CT system assemblies preferred.
  • Knowledge of process validation, equipment qualification, and audit handling is essential.
  • Skills and Competencies :

  • In-depth understanding of medical device quality systems and documentation control.
  • Strong analytical and validation skills with a methodical approach.
  • Excellent communication, coordination, and reporting abilities.
  • Proficiency in MS Office, ERP systems, and document management tools.
  • Attention to detail, process discipline, and a proactive approach to compliance.
  • Ability to work cross-functionally in a regulated manufacturing environment.
  • Key Performance Indicators (KPIs) :

  • Compliance with ISO 13485 and audit requirements
  • Timely completion of validation and documentation activities
  • Reduction in non-conformities and audit observations
  • Accuracy and completeness of quality documentation
  • Effectiveness of CAPA implementation
  • Create a job alert for this search

    Quality Control Executive • vapi, gujarat, in

    Related jobs
    • Promoted
    Sr. Quality Control Manager

    Sr. Quality Control Manager

    CIRCOR International, Inc.Daman, Republic Of India, IN
    The candidate position is for Manager Quality should having through knowledge of quality functions a of quality department. He should be a key driver for quality improvement.He will collaborate with...Show moreLast updated: 2 days ago
    • Promoted
    Asst / Dy Manager Quality

    Asst / Dy Manager Quality

    Tsubaki Nakashima Co., LtdVapi, Gujarat, India
    Location : Silvassa, Bhilad (Vapi).Graduate Engineer / Science with.PG diploma in Quality Management systems.Auto Ancillary, Tool manufacturing ,Ball manufacturing industry preferred.Responsible for...Show moreLast updated: 2 days ago
    • Promoted
    Area Head (Center Manager)

    Area Head (Center Manager)

    Dr Reddy's Foundationdaman and diu, daman and diu, in
    Reddy’s Foundation (DRF) is a not-for-profit organization, focused on enhancing the dignity and well-being of socially and economically vulnerable people. We empower communities through improved edu...Show moreLast updated: 30+ days ago
    • Promoted
    Assistant Quality Control Manager

    Assistant Quality Control Manager

    Tsubaki Nakashima Co., LtdVapi, Republic Of India, IN
    Location : Silvassa, Bhilad (Vapi).Graduate Engineer / Science with.PG diploma in Quality Management systems.Auto Ancillary, Tool manufacturing ,Ball manufacturing industry preferred.Responsible for...Show moreLast updated: 2 days ago
    • Promoted
    Quality Engineer

    Quality Engineer

    Magnify Industries Pvt LtdValsad, Gujarat, India
    This comapny is engagged in manufacturing of Wire Harness and Control Boxes.This is a full-time on-site role for a Quality Engineer located in Valsad. The Quality Engineer will be responsible for de...Show moreLast updated: 30+ days ago
    • Promoted
    Food Technologist

    Food Technologist

    V. P. BEDEKAR & SONS PVT. LTD.Umargam, Gujarat, India
    Pickles and Spices under Brand name "Bedekar".This is a full-time on-site role for a Food Technologist located in Umargam. The Food Technologist will be responsible for Supervising the Manufacturing...Show moreLast updated: 23 days ago
    • Promoted
    MBA Interns

    MBA Interns

    Servall Automotive Pvt LtdBilimora, Gujarat, India
    We’re Hiring : MBA Interns at Servall Two Wheeler Service! .Are you an MBA student eager to apply your classroom knowledge to real-world business challenges?. This is your opportunity to gain hands-o...Show moreLast updated: 1 day ago
    • Promoted
    Sr. Manager Quality

    Sr. Manager Quality

    CIRCOR International, Inc.Daman, Dadra and Nagar Haveli and Daman and Diu, India
    ORGANIZATIONAL STRUCTURE TITLE : Sr.Manager Quality BUSINESS : Allweiler India Pvt.LOCATION : Daman DIRECT REPORTING : Sr. Director Operations FUNCTIONAL REPORTING : Sr.Director Operati...Show moreLast updated: 2 days ago
    • Promoted
    Deputy General Manager Human Resources

    Deputy General Manager Human Resources

    UnitileUmargam, Gujarat, India
    Deputy General Manager– HR and Administration (Full Time Role).Celebrating 31 years of excellence, Unitile shines as a beacon of innovation and trust in the building materials industry.Our dedicati...Show moreLast updated: 30+ days ago
    • Promoted
    Quality Assurance & Quality Control ( engineering & Manufacturing )

    Quality Assurance & Quality Control ( engineering & Manufacturing )

    PANORAMA TECHNOLOGIESVapi, Gujarat, India
    Quality Assurance (QA) / Quality Control (QC) - Engineering & Manufacturing Develop, implement, and maintain the company’s Quality Management System (QMS) in line with ISO standards and client requi...Show moreLast updated: 1 day ago
    • Promoted
    Executive

    Executive

    Micro Crispr Pvt. Ltd.Vapi, Gujarat, India
    Develop the global regulatory strategies for biologic products across all development phases (preclinical to post-marketing) for the (US, EU, and ROW). Ensure alignment with business goals and regul...Show moreLast updated: 1 day ago
    • Promoted
    Quality Assurance Executive - noon Minutes

    Quality Assurance Executive - noon Minutes

    noonvapi, gujarat, in
    On December 12th, 2017, noon launched its consumer platform in Saudi Arabia and the UAE, expanding to Egypt in February 2019. The noon ecosystem of services now includes marketplaces for food delive...Show moreLast updated: 23 days ago
    • Promoted
    Quality Control Specialist

    Quality Control Specialist

    s d fine-chem limited OfficialTārāpur, Republic Of India, IN
    We at s d fine-Chem Limited are ISO certified and one of the largest Manufacturers of Laboratory Chemicals in Asia and are looking for a Quality Control officer at our Tarapur Factory.QC Lab for we...Show moreLast updated: 1 day ago
    • Promoted
    Quality Control Technologist - Food

    Quality Control Technologist - Food

    V. P. BEDEKAR & SONS PVT. LTD.Umargām, Republic Of India, IN
    Pickles and Spices under Brand name "Bedekar".This is a full-time on-site role for a Food Technologist located in Umargam. The Food Technologist will be responsible for Supervising the Manufacturing...Show moreLast updated: 23 days ago
    • Promoted
    Quality Engineer

    Quality Engineer

    TransPerfectvapi, gujarat, in
    A leading multinational telecommunications company (name disclosed at interview).As a Mid-Level QA Engineer, you will develop and execute tests to ensure company's products meet the highest quality...Show moreLast updated: 23 days ago
    • Promoted
    Quality Control Executive

    Quality Control Executive

    MerilVapi, Gujarat, India
    Quality Control Executive – Radiology & Imaging Systems (X-Ray / C-Arm / DR / CT).Quality Assurance – Radiology Division. Manager / Senior Manager – Quality Assurance.To ensure product and process c...Show moreLast updated: 2 days ago
    • Promoted
    Quality Assurance & Quality Control ( Engineering & Manufacturing )

    Quality Assurance & Quality Control ( Engineering & Manufacturing )

    PANORAMA TECHNOLOGIESVapi, Republic Of India, IN
    Quality Assurance (QA) / Quality Control (QC) - Engineering & Manufacturing.Develop, implement, and maintain the company’s Quality Management System (QMS) in line with ISO standards and client requi...Show moreLast updated: 1 day ago
    • Promoted
    Production Control Analyst

    Production Control Analyst

    Best Infosystems Ltd.vapi, gujarat, in
    Production Control Analyst_Full-Time_Noida (Remote)_Shift Timing : PST and overlap IST / PST.Seeking a Production Control Security Analyst that has strong technical knowledge IBM Security Verify Acces...Show moreLast updated: 30+ days ago