1091 Iso Documentation Jobs

Job Title : Officer - Documentation Functional Area : QA Key Accountabilities Technical and QMS Documentation: Preparation and Review of Documents as per ISO 13485, EU-MDR, 21CFR820, Thai FDA and Indian Medical Device Rule and ensure implementation of same. Handling of Deviation, Non-Conformance, Change controls and CAPA. Handling of Post market surveillance Preparation of the regulatory documents (TMF/Dossiers) for regulatory submission. Preparation of Technical files in co-ordination with R&D Team. Preparation of Design file as per ISO 13485:2016, MDR and USFDA. Handling of Adverse event reporting to EU and other regulatory body. Familiar to handle Eudamed, Maude and other databases Valida...

Job Description: Senior Quality and Regulatory Engineer Position Overview The Senior Quality and Regulatory Engineer will play a critical role in ensuring that medical devices meet global regulatory requirements and adhere to the highest standards of quality. This position involves leading quality system initiatives, managing regulatory submissions, and supporting product development teams to ensure compliance with ISO, FDA, and other international standards. Key Responsibilities Quality Management Systems (QMS): Maintain and improve QMS in compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable standards. Lead internal audits and support external regulatory inspections. Drive C...

Responsibilities: * Develop & implement QMS per IATF standards * Conduct internal audits according to standard * Prepare ISO documents for certification * Ensure compliance with automotive industry requirements Food allowance Health insurance Annual bonus Provident fund

Role & responsibilities: The Assistant Manager QMS will be responsible for ensuring the organization’s Quality Management System is robust, compliant, and continuously improved. This role involves managing internal and external audits, certification processes, customer audits, and driving initiatives to revamp QMS documentation and standards. The incumbent will also represent the company in external quality forums and competitions, promoting best practices and benchmarking excellence. Audit & Compliance Management: Plan, coordinate, and execute internal audits across all functions to ensure compliance with QMS standards. Manage external audits including certification audits (e.g., ISO 9001:2...

Role & responsibilities Working knowledge in ISO 9001: 2015 or equivalent. Should have good draughting skills and Capable of preparing drawings using Auto Cad. Capable of studying techincal drawings . Knowledge in Preparation of process control documents like PCP, ITP, travellers and Quality plans. Computer knowledge like MS office. Preferred candidate profile Minimum 3 years experience in Auto cad and ISO Documentation.

Role & responsibilities 1. • Manage end-to-end recruitment for all plant roles. 2.• Implement onboarding, induction, and orientation programs. 3.• Handle grievances, disputes, warning letters, disciplinary actions, and domestic inquiries. 4.• Ensure 100% compliance with all labour laws: Factory Act PF, ESI Minimum Wages Bonus, Gratuity Shops & Establishments Contract Labor Act Labour Law Act 5.• Coordinate with government regulatory authorities, maintain all statutory registers, returns & audits. 6.• Handle inspections like with proper documentation. 7.• Handle PF, Esic, Labour & Factory inspector. 8.• Oversee monthly payroll, attendance, time office, overtime, and leave management. 9.Implem...

Responsibilities: * Lead quality assurance processes from planning to implementation. * Ensure compliance with ISO standards through documentation and audits.

• Develop & monitor quality systems to meet customer requirements • Inspect raw materials, in-process & finished products • Ensure compliance with ISO 9001, IATF 16949 & maintain records • Support audits & train teams on quality standards Required Candidate profile • 3-6 years’ experience in quality dept. of a reputed company • Prior exposure to customer & agency audits • Strong communication: Hindi, Marathi & English • Proficient in MS Excel & Word

Senior Engineer - Quality - Noida, India Education: Diploma/B. Tech- Mechanical Experience: 4 to 6 Years in the Quality department in an Auto component Manufacturing company Interested? Share CV shubha@hireindians.com Call/WhatsApp +91 81782 23314 Required Candidate profile Excellent knowledge of Injection Moulding Process & SAP ISO-9001:2015, IATF, and VSA documentation PPAP (Production Part Approval Process) preparation & submission Note: Immediate Joiners preferred

COMPANY PROFILE Shri Bhagwati Machines Pvt. Ltd., (SBMPL), Ajmer (Raj.) is accredited by TUV/SUD ISO, IMS & OH&S 9001: 2015, 14001:2015 & 45001:2018 and Certified OEM. SBMPL was incepted in 1995. We, are pleased to introduce ourselves as a reputed OEM for more than 25 years a leading manufacturer, supplier, and exporter of stone processing machinery at National & International Level. We are always conscious of preparing machines with the latest technology, robust and heavy duty, better performance, productivity and after-sales services. To meet all of the above qualities, SBMPL is the leading manufacturer with an innovative approach to the Mechanical Engineering of Stone Cutters Machines, an...

Responsibilities: * Lead ISO implementations & audits * Ensure compliance with QMS standards * Manage quality systems & documentation * Oversee CAPAs & system improvements * Drive continuous improvement initiatives Health insurance Provident fund Annual bonus

Hiring for Shanthala Spherocast: Supervise production and quality operations, ensure process control, inspection compliance, documentation, rejection reduction, and smooth coordination with shop floor and management.

Quality control systems, knowledge of ISO documentation essential , experience of more than 8 years

As a Senior Estimation & Costing Engineer - (Pre tendering) Electrical at our client's Ahmedabad based company, your role involves the following responsibilities: - Scrutinize tender documents thoroughly to understand the requirements. - Evaluate tender documents, drawings, and schedules to develop accurate estimations. - Float inquiries to suppliers and manufacturers to gather quotations. - Conduct comparison studies based on suppliers' quotations to make informed decisions. - Negotiate with suppliers on technical and commercial aspects of products. - Perform Value engineering studies based on clients' budget constraints for specific projects. - Maintain ISO documentation, records, and supp...

Location: Harohalli Inward Inspection, Outward Inspection, Quality check, Quality Assurance, Audits Salary: 42000 Take home, CTC 600000 per annum to the deserving candidates Qualification: BE Mechanical Kannada Mandatory Contact- Satish, 9632287143

Managing and implementing QMS with deep expertise in ISO 9001, ISO 14001, ISO 45001, and IATF 16949. Experience in forging manufacturing is a must. Drive continuous improvement initiatives, focusing on reducing waste & improving efficiency. Required Candidate profile Implement (CAPA) based on audits, customer feedback, and internal analysis. Oversee risk management procedures to identify and address potential quality issues before they escalate.

Responsibilties: Lead preventative & predictive maintenance strategies Ensure compliance with ISO standards Oversee hydraulic system upkeep Manage breakdowns through corrective action Interested candidate send resume on hr@sonacaindustries.com Health insurance Annual bonus Provident fund

to handle complete ISO documentations, ensure compliance, involving developing procedures, maintaining Doc. records, conducting audits, expert in Process of ISO documentations with good communication skills. job location Kundrodi Kuch Gujarat. Required Candidate profile to handle complete ISO documentations, ensure compliance, involving developing procedures, maintaining Doc. records, conducting audits, expert in Process of ISO documentations etc. Perks and benefits CTC 55kpm, with bachelor accommodation & Foods.

Engineer - Quality - Faridabad, India Education: Diploma/B. Tech- Mechanical Experience: 4 to 6 Years in the Quality department in an Auto component Manufacturing company Interested? Share CV shubha@hireindians.com Call/WhatsApp +91 81782 23314 Required Candidate profile ISO 9001:2015 documentation and compliance PPAP (Production Part Approval Process) preparation and submission Calibration and repair of quality instruments & gauges Note: Immediate Joiners preferred

Role & responsibilities 1. Tool Planning & Management 2. Control tooling cost and minimize tool wastage 3. Provide tooling support to Machine shop( VMC, HMC) 4. Coordinate with Production team and Process Engineering for new part development. 5. Maintain tool inventory, tool life tracking, and tool history records 6. Monitoring Tool life 7. Ensure timely repair, modification, and reconditioning of tools 8. Ensure tools and gauges meet drawing and quality standards 9. ISO Documentation & Reporting to HOD 10. Coordinate with external tool makers and suppliers 11. Evaluate vendor quality, cost, and delivery performance & Support purchase of new tools and spares with technical inputs. Preferred ...

Role & responsibilities 1.Develop and implement the Quality Management System 2. In-Process & Final Inspection Control 3. Customer Quality Management 4. Supplier Quality Assurance 5. Quality Compliance & Documentation 6.Continuous Improvement & Problem Solving 7.Team Management Preferred candidate profile

Establishes, enforces, and oversees compliance for an effective Quality Management System within the scope of activities, ensuring streamlined and efficient QMS structures and documentation across all levels. Manages the deployment of the QMS. Required Candidate profile IATF-16949 & ISO 9001, ISO13485,AS 9100,ISO 14001 ISO 45001 standards knowledge in SPC,Gage R&R, MSA FMEA, Certified internal auditor for IATF, ISO 9001,ISO 13485,AS 9100, ISO14001 ISO 45001.

Job Summary The Senior Quality Engineer is responsible for ensuring that all sheet metal components and products meet the companys quality standards. This role involves developing inspection processes, solving quality issues, supporting continuous improvement, and maintaining compliance with quality systems. Key Responsibilities Monitor and control quality across all sheet metal processes (cutting, bending, welding, fabrication, finishing). Conduct in-process and final inspections as per drawings and specifications. Lead root cause analysis and corrective/preventive actions for quality issues. Develop and maintain quality documents: inspection reports, checklists, SOPs. Work closely with pro...

knowledge of QMS. ISO Audit. Quality Audit. Internal audit. Preparing customer required documents (PPAP, IATF 16949, EMS & OHSAS, FMEA, CP, PFD). Look after various ISO certification & documentation (ISO9001:2015 ISO 14001:2015 AND ISO 45001:2018).

1. Documentation of all processes and system and responsible for storage of all IATF related Certificates and Documents 2. Implementation of 4M Change Management and Verification of 4M Change Matrix and Records 3.closing of all customer complaints Required Candidate profile 4. Find the Root cause analysis and Corrective and Preventive Actions and Submit 8D 5. Lead the implementation of 5S in plant effectively. 6. Conducting regular 5S audits. 7. facing external audits