850 Iso Standards Jobs - Page 20

Role Overview The Head QA/RA will be responsible for leading Regulatory Affairs (RA) and Quality Assurance (QA) functions to ensure compliance with Indian & International medical device regulations (MDR 2017, EU MDR 2017/745, US FDA 21 CFR, ISO 13485). This role will be pivotal in driving product approvals, managing audits, and maintaining the highest standards of product quality and regulatory compliance. Role & responsibilities Regulatory Affairs (RA): Submission of documents to State FDA & CDSCO, New Delhi for approval of additional domestic/export products. Renewal of Drug Manufacturing License as per statutory requirements. Arrange FSC, Non-Conviction Certificate, QMS Certificates from ...

About the Role :We are seeking a detail-oriented and proactive ISO Certification Assistant to support our organization in achieving and maintaining ISO certification (e.g., ISO 9001, ISO 14001, ISO 27001, etc.). This role will involve assisting with documentation, audits, compliance activities, and process improvements to ensure we meet international standards and regulatory requirements. Role & responsibilities Assist in preparing, organizing, and maintaining ISO-related documentation, policies, and procedures. Support internal and external audit processes, including scheduling, coordination, and evidence collection. Monitor compliance with ISO standards and identify areas for improvement. ...

Design engg of Material handling system such as Ash Handling System etc NPD activities support manager Know materials & other engg standards eg. IS, ASME, DIN General arrangement drawings, data sheets, mfg drawing & BoMs know environmental standards Required Candidate profile Technical clarification of design with dept, client, agencies -coordinate with foreign office -Supervise team -Inventor 3D CAD Preference to Early Joiner share cv; info.dronehr@gmail.com 9990013340-WA

Quality Assurance- Cold Rolling Division (Annealing and Bright Annealing Line, Pickling Line, slitting) Lead and manage the quality control processes for stainless steel strips, with a strong focus on strip cold rolling, Annealing & Pickling, slitting operations. Manage quality checks for the product process start to end, ensuring proper measurements, tolerances, and finishing of products. Develop, implement, and monitor quality assurance systems to enhance product quality and reduce defects. Ensure compliance with ASTM, BIS standards and implement industry best practices for product quality and safety. Sound knowledge in Product Failure Analysis, Microscopy, Phase diagram, Metallography Imp...

Job Title: Electronics Engineer Single ARM Application (Medical Robotics) Location: Gurgaon, India Department: R&D / Engineering Employment Type: Full-time Job Summary: We are seeking a highly skilled Electronics Engineer to join our medical robotics team, focusing on the development and integration of Single Arm robotic systems used in Medical Robotics. You will be responsible for the design, development, testing, and validation of electronic subsystems including control boards, motor drivers, sensors, and safety circuits. Key Responsibilities: Design and develop electronic hardware for a single robotic arm used in medical applications. Develop and test embedded systems using microcontrolle...

Description We are seeking a detail-oriented QC Inspector to join our team in UAE The ideal candidate will be responsible for ensuring that our products meet stringent quality standards and specifications. This role requires a proactive approach to quality assurance and a commitment to continuous improvement. Skills and Qualifications 5-15 years of experience in quality control or quality assurance roles. Diploma / BE Mechanical Engineer with Oil & Gas experience is a must, GCC experience is a must, ADNOC experience will be an advantage. QC Inspector QC Engineer QC Assistance CSWIP BGAS Painting

We are seeking a proactive Sr Medical Editor to join our team, responsible for ensuring the quality, accuracy, and compliance of medical documents. The ideal candidate will have extensive experience in copyediting, data integrity review, and project management within the medical writing field. This role involves acting as a subject matter expert, mentoring staff, and leading projects to ensure deliverables meet all sponsor and regulatory requirements. Role & responsibilities Maintains familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance. Represents the editorial group in Medical...

We are seeking a proactive Sr Medical Editor to join our team, responsible for ensuring the quality, accuracy, and compliance of medical documents. The ideal candidate will have extensive experience in copyediting, data integrity review, and project management within the medical writing field. This role involves acting as a subject matter expert, mentoring staff, and leading projects to ensure deliverables meet all sponsor and regulatory requirements. Role & responsibilities Maintains familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance. Represents the editorial group in Medical...

We are seeking a proactive Sr Medical Editor to join our team, responsible for ensuring the quality, accuracy, and compliance of medical documents. The ideal candidate will have extensive experience in copyediting, data integrity review, and project management within the medical writing field. This role involves acting as a subject matter expert, mentoring staff, and leading projects to ensure deliverables meet all sponsor and regulatory requirements. Role & responsibilities Maintains familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance. Represents the editorial group in Medical...

Position: Production Manager / Deputy Manager (Female Candidates Only) Location: Nashik Experience: 10 to 15 Years Job Description: Responsible for overall shop floor management in a manufacturing setup (preferably Electronics / MNC). Drive TPM, MOST techniques, Lean Manufacturing and ensure production efficiency. Manage and lead a team of 60 to 70 female members, ensuring smooth operations and adherence to quality standards. Implement continuous improvement initiatives for cost, quality, and productivity. Coordinate with cross-functional teams for timely achievement of production targets. Requirements: 1015 years of relevant experience in manufacturing industry (electronics preferred). Prov...

Post* *QMS- Sr. Engineer/Assit Manager *Urgent Opening @ Ranjangaon MIDC, Karegaon, Shirur* . *Interview arrangement* *Contact -9356395439* *Experience* -06-08 yrs *CTC -4.20-5.00 lpa* 1) *ISO-9001/14001 Compliance* : Maintain an organization's quality management system to ensure compliance with ISO standards 2) *Documentation* : Ensure that all quality-related documentation, including policies, procedures, work instructions, and records, are maintained and updated as required by ISO standards. 3)Co-ordinate with all departments for system compliance 4) Closing of audit Internal and External. 5) Maintain MR/System Records. 6) *Internal Audits* : Plan, conduct, and report on internal audits t...

Description We are seeking a highly skilled Quality Management System (QMS) Manager to lead our quality initiatives and ensure compliance with industry standards. The ideal candidate will have extensive experience in developing and managing QMS, driving continuous improvement, and fostering a culture of quality across the organization. Responsibilities Develop, implement, and maintain the Quality Management System (QMS) in accordance with ISO standards. Conduct internal audits and manage external audits related to the QMS. Monitor and report on QMS performance metrics and compliance standards. Identify areas for improvement in processes and systems to enhance quality and efficiency. Train an...

Develop, implement, and monitor quality management systems in line with ISO, ASME, AWS, or equivalent standards.Prepare and execute PQP, ITP and Method Statements. knowledge of ISO 9001, welding codes (AWS, ASME), fabrication & erection standards. Required Candidate profile Experience in quality audits, inspections, NDT, WPS/PQR, and QMS implementation. Certification in Lead Auditor – ISO 9001/QMS is highly desirable.

Job Summary We are seeking a skilled Cybersecurity Engineer to design, implement, and manage security controls, ensuring compliance with ISO/IEC 27001, 27002, and ISO 13485 standards. The role involves integrating security practices into the SDLC , supporting audits, performing threat modeling, managing vulnerabilities, and fostering a strong security culture. Key Responsibilities Implement and monitor security controls within the SaaMD development lifecycle. Ensure compliance with ISO standards and support internal/external audits. Conduct threat modeling, penetration testing, and code analysis. Manage vulnerabilities and drive remediation across teams. Prepare detailed security reports and...

Role & responsibilities Job Description -Software Quality Engineer (QA/RA) Design, develop, and optimize high-performance SAMD applications using SIMD for real-time. Ensure all software development complies with regulatory standards such as IEC 62304, ISO 13485, FDA 21 CFR Part 820, and EU MDR. Collaborate with cross-functional teams (RA/QA, Software/firmware development, and R&D teams) to ensure the software meets safety and performance requirements. Create and maintain documentation such as SDLC deliverables, Risk management files, Verification and Validation protocols, Usability, and Cybersecurity deliverables. Participate in internal audits, regulatory submissions, and post-market survei...

Design engg of Material handling system such as Ash Handling System, Soot Blowers etc. NPD activities Know materials & other engg standards eg. IS, ASME, DIN General arrangement drawings, data sheets, mfg drawing & BoMs knows environmental standards Required Candidate profile Technical clarification of design with dept, client, agencies -coordinate with foreign office -Supervise team -Inventor 3D CAD Preference to Early Joiner share cv; info.dronehr@gmail.com 9990013340-WA

Role & responsibilities Maintains familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance. Represents the editorial group in Medical Writing, on study teams, and in cross-departmental project teams as needed. Monitors timelines and budgets for assigned projects and updates the Lead Medical Writer, Project Manager, and/or direct supervisor (as appropriate) if deliverables are at risk. Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medical editors, and study teams on data integrit...

Role & responsibilities Maintains familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance. Represents the editorial group in Medical Writing, on study teams, and in cross-departmental project teams as needed. Monitors timelines and budgets for assigned projects and updates the Lead Medical Writer, Project Manager, and/or direct supervisor (as appropriate) if deliverables are at risk. Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medical editors, and study teams on data integrit...

Role & responsibilities : Minimum 5 years of experience in Project Management. Must possess excellent communication skills and should be proficient in Microsoft Office. Should have prior experience in team handling. Mentors and leads less experienced medical writers on complex projects, as necessary. Acts as lead for assigned writing projects. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Compiles, writes, and edits medical writing deliverables including operating guidance documents, SOPs, training guides, etc., and serves as a medical writer within and across departments ...

Compiles, writes, edits, and coordinates medical writing deliverables that present scientific information clearly and accurately, and works as a medical writer within and across departments with minimal or moderate supervision. Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports; journal manuscripts; and abstracts, posters, and presentations for scientific meetings. Adheres to established regulatory standards, including, but not limited to, ICH E3 guideline...

Compiles, writes, edits, and coordinates medical writing deliverables that present scientific information clearly and accurately, and works as a medical writer within and across departments with minimal or moderate supervision. Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments; clinical study reports; patient narratives; annual reports; investigator brochures; informed consents; annual reports; plain language summaries; periodic safety update reports; journal manuscripts; and abstracts, posters, and presentations for scientific meetings. Adheres to established regulatory standards, including, but not limited to, ICH E3 guideline...

Manual Testing Proven prior hands-on experience (5+ years) in testing medical device software Prior experience in Integration, Regression and System testing. Prior experience in tools like HP ALM Experience in FDA compliant test documentation. Experience in Agile development processes and methodologies. Possess sound knowledge of test methodologies. Experience is defect management tool Strong knowledge of STLC System requirement analysis Author detailed Test plan, test protocols, trace matrices and test reports Good documentation practice.

Senior Security and Compliance Engineer Experience: 5 - 8 Years Exp Salary : competitive Preferred Notice Period : Within 30 Days Opportunity Type: Hybrid (Bengaluru) Placement Type: Permanent (*Note: This is a requirement for one of Uplers' Clients) Must have skills required : Information Security OR Statutory Compliance, Cloud Security Hiver (One of Uplers' Clients) is Looking for: Senior Security and Compliance Engineer who is passionate about their work, eager to learn and grow, and who is committed to delivering exceptional results. If you are a team player, with a positive attitude and a desire to make a difference, then we want to hear from you. Role Overview Description Opportunity: ...

Job description Responsibilities: Qualify suppliers according to company standards & management of approved supplier list per purchasing control compliance. Initiate and drives SCAPAs/NCRs to suppliers not performing/or adhering to company standards. Manage supplier change requests . Assess supplier performance on periodic basis & drive necessary action for continous improvement. Establish a process & ensures that suppliers deliver quality parts, materials, and services. Lead PPAP execution with supplier and ensure robust supplier process qualification/validation through IQ, OQ & PQ methodology. Monitors parts from acquisition through the manufacturing cycle and communicates and resolves sup...

As the Design Head of Packaging Machinery, you will be responsible for leading mechanical design and research & development activities for high-speed packaging and bottling machinery to ensure continuous innovation, superior quality, and optimal performance. Your key role will involve overseeing the design of various components such as moulds, conveyors, filling lines, and packaging machinery. You will be tasked with managing the entire product development lifecycle from conceptualization to commissioning. It will be your responsibility to ensure compliance with CE, ISO, GMP standards, and customer specifications. Additionally, you will be expected to implement design automation, CAD best pr...