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7.0 - 12.0 years
8 - 13 Lacs
sanand, ahmedabad
Work from Office
Hiring for Quality role US MNC company. Role & responsibilities : To establish & sustain robust quality processes for equipment manufacturing supplied to pharmaceutical, food, and chemical industries. The role demands hands-on expertise in CE & ATEX certification, preparation of technical quality documentation, and standardization of QA/QC formats across the supply chain and final assembly. The role requires competency to handle to handle document traceability, Document packages, & Customer Inspection. Description Process Setup & Documentation Develop and implement quality assurance plans, checklists, and inspection test plans (ITPs) tailored for pharma/food equipment. Prepare and maintain c...
Posted 5 days ago
5.0 - 10.0 years
5 - 15 Lacs
jaipur
Work from Office
Role Overview: NeuroEquilibrium is looking for Regulatory Affairs Specialist responsible for regulatory submissions, product registrations, license renewals, and compliance for medical devices in India and other countries. Supports Quality Management System (QMS), audits, CAPA, supplier/distributor quality, and ensures compliant labeling, documentation, and distribution practices in line with medical device regulatory requirements. What is the role like: For this role, we are looking for the people who has exposure in the global compliance requirements and documentation into healthcare and medical devices segments. Additional responsibilities, this role will have as below: Ensure regulatory ...
Posted 1 week ago
3.0 - 8.0 years
10 - 15 Lacs
indore, pune, mumbai (all areas)
Work from Office
Company Name : Willware Technologies Work Model: Full Time (On-Site) Work Location: Pune Experience : 3 to 6 Years Role & responsibilities Regulatory Strategy : Develop strategies for market access and regulatory approvals. Regulatory Compliance : Ensure medical devices comply with EU MDR (2017/745) and other relevant regulations. Technical Documentation : Prepare and maintain Technical Files Regulatory Submissions: Handle CE Marking, Notified Body interactions, and EU registrations. Post-Market Surveillance: Adverse events, vigilance reporting, and Periodic Safety Update Reports (PSURs). Labeling & UDI Compliance: Ensure product labeling and Unique Device Identification (UDI) requirements a...
Posted 1 week ago
10.0 - 15.0 years
15 - 18 Lacs
pune
Work from Office
Oversee fabrication of pressure vessels and heat exchangers per ASME, TEMA, and PED standards. Ensure material selection aligns with project specifications. Implement stage-wise inspection
Posted 3 weeks ago
0.0 years
0 Lacs
bengaluru, karnataka, india
On-site
Job Overview Collaborates with various stakeholder groups, supervises the activities of junior systems engineers, and provides input to the team's technical objectives. Responsibilities Integrated System Design & Architecture Define the technical architecture for the entire identification ecosystem, ensuring seamless interaction between software, firmware, and hardware components. Lead the technical integration of new printer models and software features into TE's product portfolio. Develop and maintain system-level specifications and interface control documents Hardware Development & Lifecycle Management Serve as the primary technical expert for all thermal transfer printer hardware and acc...
Posted 1 month ago
5.0 - 10.0 years
0 Lacs
indore, madhya pradesh
On-site
Role Overview: You will be joining Nivo Controls as a Senior Engineer in the R&D department with the primary responsibility of product development for instrumentation products. Your role will involve designing and developing process control instruments, verifying and validating products, developing embedded products, implementing international standards, project planning and execution, PCB layout development, inter-departmental coordination, and technical documentation. Key Responsibilities: - Design and Development of Process Control Instruments. - Design Verification and Validation of Products. - Embedded Product development. - Implementation of International Standards including EMI/EMC, G...
Posted 1 month ago
8.0 - 12.0 years
0 Lacs
pune, maharashtra
On-site
As a Sr. Compliance Engineer at SPX FLOW in Pune, you will play a crucial role in ensuring compliance with various standards for products used in explosive atmospheres. Your responsibilities will include coordinating with product development teams, notified bodies, and maintaining certification documentation. You should have a strong engineering background and be comfortable working in cross-functional environments. Key Responsibilities: - Support ATEX-related compliance activities for products used in potentially explosive atmospheres - Collaborate with design and product teams to ensure compliance with EMC/EMI, UL, LV, CE, and EU Machinery Directive - Coordinate certification processes inc...
Posted 1 month ago
0.0 years
0 Lacs
india
On-site
Regulatory Documentation & Compliance Specialist (FCC, CE, FDA, RoHS, Cybersecurity) About Us Brainwave Science is a global neurotechnology company dedicated to transforming how brainwave data is understood and applied. With over a decade of research and innovation, the company has developed advanced cognitive assessment solutions such as iCognative , empowering agencies across security, intelligence, and law enforcement to uncover concealed information through neuroscience. Our expertise lies in combining EEG-based analytics, AI, and cognitive neuroscience to create technologies that deliver measurable, real-world impact. Expanding this vision into wellness and lifestyle, Basil Health focus...
Posted 1 month ago
6.0 - 10.0 years
12 - 14 Lacs
bengaluru
Work from Office
Role & responsibilities The QA & Regulatory Affairs Manager leads and oversees all regulatory and quality assurance activities within the company, ensuring that all products comply with local and international medical device regulations . The role is responsible for developing and executing regulatory strategies , managing submissions and approvals , and maintaining strong relationships with health authorities, notified bodies, and certification agencies to support product launches and lifecycle management. A core aspect of this position is to build and implement a full Quality Management System (QMS) compliant with ISO 13485:2016 , and to ensure regulatory readiness for global markets inclu...
Posted 1 month ago
8.0 - 10.0 years
5 - 11 Lacs
chennai
Work from Office
Role & responsibilities Develop and execute regulatory strategies for CE marking (under EU MDR), US FDA approvals (510(k)/PMA), and CDSCO manufacturing and marketing authorizations. Ensure timely preparation, submission, and maintenance of regulatory dossiers including Technical Files, Design Dossiers, and Device Master Files. Act as primary contact with regulatory authorities (CDSCO, Notified Bodies, US FDA) and manage communications during audits, inspections, and submissions. Oversee the creation, maintenance, and submission of all regulatory documentation to ensure compliance with global regulations. Support product development teams to ensure regulatory requirements are embedded through...
Posted 1 month ago
6.0 - 10.0 years
12 - 14 Lacs
bengaluru
Work from Office
Role & responsibilities The QA & Regulatory Affairs Manager leads and oversees all regulatory and quality assurance activities within the company, ensuring that all products comply with local and international medical device regulations . The role is responsible for developing and executing regulatory strategies , managing submissions and approvals , and maintaining strong relationships with health authorities, notified bodies, and certification agencies to support product launches and lifecycle management. A core aspect of this position is to build and implement a full Quality Management System (QMS) compliant with ISO 13485:2016 , and to ensure regulatory readiness for global markets inclu...
Posted 1 month ago
2.0 - 5.0 years
2 - 3 Lacs
bhiwadi
Work from Office
We are looking for a QC / QA Executive to join our Dental Manufacturing Unit in Bhiwadi . The ideal candidate will ensure product quality, process efficiency, and full compliance with ISO 13485 and GMP standards throughout all manufacturing stages. Key Responsibilities: * Perform chemical and physical testing of materials and finished products. * Conduct testing of raw materials, in-process samples, and finished goods as per specifications. * Manage manufacturing processes and perform routine quality checks. * Document and communicate analysis results accurately. * Maintain analytical records, COAs, and stability data. * Perform and document instrument calibration (pH meter, viscometer, spec...
Posted 1 month ago
3.0 - 7.0 years
0 Lacs
bengaluru, karnataka, india
On-site
Job Requirements To study the Transactional compliance Plan for every project and document the list of applicable Regulations and Standards. Preparation of Compliance documents for specific projects with list of impacted items from the TRS Matrix. Work with the suppliers to ensure that the parts / assemblies manufactured by them meet the compliance requirement of the project. Collect and compile the documents / certificates for the project and upload the central repository. Work with Design team on regular basis and initiate the improvement actions. Adopt the best practices from other business and incorporate. Schedule the meetings with other teams to ensure compliance is met. Work Experienc...
Posted 1 month ago
0.0 - 3.0 years
1 - 4 Lacs
mumbai
Work from Office
Record all transactions accurately in compliance with accounting principles and reconcile accounts Preparing and entering invoices, bills, checks etc. Assisting with taxation including filing returns of GST/TDS Assisting with preparation of MIS, balance sheets, income statements and other reports Knowledge of regulatory compliance and accounting principles Proficiency in accounting software (tally) and MS Suit (in particular MS Excel) Open to learning ZOHO Quickbooks
Posted 2 months ago
10.0 - 15.0 years
5 - 14 Lacs
chennai
Work from Office
We are seeking an experienced Consultant with deep expertise in CE Marking and Indian Standards (IS/BIS) to support Omnex clients in achieving product compliance and certification project implementation, client engagement, and training delivery.
Posted 2 months ago
3.0 - 7.0 years
6 - 8 Lacs
mumbai, new delhi, pune
Work from Office
Job Description : Associate/Sr. Associate - BIS Certification Position/Location : Full Time/New Delhi, India Salary: Best as per the industry standard. Company Overview : REACHLaw is a Finland-based company that provides chemical regulatory compliance, product safety and sustainability solutions to companies worldwide. With a global presence, REACHLaw operates from strategically located offices in Finland, UK, Belgium, India, Trkiye, South Korea and Ukraine. Founded in 2006, REACHLaw specializes in helping clients with navigating complex regulations related to the registration, evaluation, authorization, and restriction of chemicals (REACH) in the European Union (EU) and other REACH like glo...
Posted 2 months ago
10.0 - 12.0 years
0 Lacs
india
Remote
Job Title: Senior Robotics Engineer Trainer Location: Remote Job type: Part-time Job Summary: We are seeking an experienced Robotics Engineer Trainer with over 10 years of hands-on expertise in robotics system design, programming, integration, and industrial automation. The trainer will be responsible for developing and delivering training programs that enhance the technical skills of engineers, technicians, and students in robotics and automation technologies. The ideal candidate will have in-depth knowledge of robotic systems (such as FANUC, ABB, KUKA, or UR), control systems, and mechatronic integration, along with the ability to effectively communicate complex technical concepts. Key Res...
Posted 2 months ago
10.0 - 12.0 years
0 Lacs
gurugram, haryana, india
On-site
Job Title: Quality Head Sudhir Srivastava Innovations Private Limited Location: Udyog Vihar, Phase-III, Gurgaon, Haryana Employment Type: Full Time Relevant Experience: 7+ Year's Salary: As per the Industry Standard Position Summary: SSII, an US based medical devices company engaged in developing and manufacturing class II & III Surgical Robots is seeking a Head Quality for its Gurgaon, India location. Join an organization with a passion for commercializing smart, effective and patient centric Robotics solutions. The Head of Quality is a key member of the site Leadership Team, and this role leads the SSII Quality and Quality System functions in India. This role will be a critical leader of a...
Posted 2 months ago
4.0 - 6.0 years
4 - 6 Lacs
bengaluru, karnataka, india
On-site
The role of PPE Technical Assessor will involve undertaking technical file reviews of clients documentation over various PPE standards and drafting certificates upon completion and handling customers enquiries where required. A broad technical background is essential for this role. Technical Assessors should have work experience i.e. employment, auditing, testing or inspection within PPE environment. Understanding performance standards and assessing PPE technical documentation is a must. Candidate must have knowledge of the PPE products industry and an understanding of European legislation and CE marking, gained from a manufacturing, test and certification background and a technical qualific...
Posted 2 months ago
3.0 - 7.0 years
3 - 7 Lacs
vadodara, gujarat, india
On-site
As a Product Assessor , you will be responsible for conducting comprehensive assessments of Soft Tissue products, ensuring technical file reviews adhere to all applicable requirements, including the European Medical Device Regulation (MDR), Medical Device Directive (MDD), and UKCA for Class IIa/IIb and/or Class III devices. Your role will involve ensuring that these assessments are technically sound and compliant with relevant regulations. You will also: Support CE marking activities carried out by SGS. Contribute to the training and qualification of junior staff, including the creation of training materials. Communicate effectively with team members and clients regarding product assessments...
Posted 2 months ago
3.0 - 7.0 years
4 - 8 Lacs
jamnagar, gujarat, india
On-site
As a Product Assessor , you will be responsible for conducting comprehensive assessments of Soft Tissue products, ensuring technical file reviews adhere to all applicable requirements, including the European Medical Device Regulation (MDR), Medical Device Directive (MDD), and UKCA for Class IIa/IIb and/or Class III devices. Your role will involve ensuring that these assessments are technically sound and compliant with relevant regulations. You will also: Support CE marking activities carried out by SGS. Contribute to the training and qualification of junior staff, including the creation of training materials. Communicate effectively with team members and clients regarding product assessments...
Posted 2 months ago
15.0 - 20.0 years
0 Lacs
tamil nadu
On-site
As a Production Engineer at FLSmidth Cement's Arakkonam plant, your role is pivotal in maintaining product quality and ensuring timely production. You will have the opportunity to work in an international environment with diverse challenges and cultures. Your responsibilities include: - Running the Plant Production efficiently for E&I and Automation, taking complete responsibility for People, Production, and Product Quality. - Reviewing design drawings and bill of materials periodically to highlight deviations and changes in machine assembly. - Coordinating with vendors, contractors, and internal teams to ensure timely delivery. - Maintaining accurate project records and updated drawings thr...
Posted 2 months ago
5.0 - 8.0 years
10 - 18 Lacs
pune
Work from Office
About the Role We are seeking a Machine Safety Expert responsible for assessing industrial machinery and production lines to ensure compliance with EU Machinery Directive 2006/42/EC , ISO 12100:2010 , and other harmonized European standards. The role focuses on ensuring that all equipment functions safely, efficiently, and in accordance with international safety regulations. Key Responsibilities Conduct machine safety audits , risk assessments , and CE marking conformity evaluations for industrial machines and production lines. Inspect mechanical, electrical, pneumatic, and hydraulic systems to identify potential hazards or non-compliances. Assess and test machine safety control systems to v...
Posted 2 months ago
10.0 - 15.0 years
0 Lacs
india
On-site
Company Overview: If a culture of excellence, innovation and ownership is what you're searching for, consider putting your experience in motion at Flowserve. As an individual contributor, or as a leader of people, your enterprise mindset will ensure Flowserve's position as the global standard in comprehensive flow control solutions. Here, your opportunity for professional development and industry leading rewards will be supported by our foundational commitments to the values of people first, integrity and safety. Thinking beyond opportunity and reward, at Flowserve, we are inspired by working together to create extraordinary flow control solutions to make the world better for everyone! Job S...
Posted 3 months ago
7.0 - 11.0 years
0 Lacs
maharashtra
On-site
As a Supplier Quality Assurance Specialist, your role involves ensuring the quality of supplier-manufactured products and processes to meet required standards and maximize customer satisfaction while adhering to procedures and processes. Your responsibilities include: - Supporting new product launches to ensure supplier quality meets requirements - Analyzing supplier evaluation and audits, and taking appropriate actions - Implementing a Supplier improvement program for key suppliers - Collaborating with Engineering team to define process parameters and criteria - Leading the supplier approval process by assessing capabilities and risks - Conducting technical audits/process audits for various...
Posted 3 months ago
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