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7.0 - 11.0 years
0 Lacs
tamil nadu
On-site
As a Senior Engineer in Quality Management, your primary responsibility will be to implement internal and external requirements for the integrated quality management system in accordance with ISO 9001, 14001, and 45001 standards. You will be tasked with executing the implementation, initiating corrective and preventive actions, and providing support to other departments in meeting management system requirements. Your key responsibilities will include supporting the implementation of quality management system requirements, conducting inspections and testing to ensure quality standards are met, and identifying areas for improvement in products and procedures. Strong communication and interpersonal skills will be essential in this role, along with knowledge of standard measuring instruments, ASME, ISO, ANSI, AISI, DIN & JIS standards, and calibration management of gauges and tools. Proficiency in English, MS Office, and SAP QM module will also be required, along with the ability to read mechanical drawings and understand product certification compliance requirements. In your day-to-day activities, you will monitor product quality in production, prepare and update quality documents, identify new instrumentation and control needs, participate in departmental improvement processes, conduct online training on quality issues, and manage non-conformances detected in production. You will also be responsible for analyzing and resolving production issues, guiding problem-solving activities, maintaining records and statistics, and supporting the introduction of new products and processes. Additionally, you will be involved in complaint management by analyzing and implementing corrective and preventive actions, conducting in-process and final inspections to ensure product quality, and supporting Kaizen activities within the organization. Your qualifications should include a Bachelor's degree in Mechanical, Electronics, or Electrical Engineering, along with 7 to 10 years of relevant work experience. Knowledge of 7QC tools, NDT, SPC, and MSA, as well as experience in supplier quality and calibration management, will be necessary. Preference will be given to candidates with ISO9001-2015 Lead/Internal Auditor Certification and expertise in surface treatment processes. Overall, as a Senior Engineer in Quality Management, you will play a crucial role in ensuring the quality of products and procedures, maintaining compliance with quality standards, and driving continuous improvement initiatives within the organization.,
Posted 2 weeks ago
3.0 - 5.0 years
2 - 5 Lacs
Kolkata
Work from Office
Strong knowledge of FDA QSR, ISO 13485, EUMDR & regulatory norms. Manage QMS docs, DHFs, CAPAs, audits, suppliers, training & calibration. Support audits, product dev, quality improvements & regulatory compliance. Excellent doc & comm skills needed.Regulatory Compliance: Apply your strong knowledge of FDA QSR, ISO 13485, and EU MDR to ensure all activities meet regulatory norms. QMS Management: Manage essential Quality Management System (QMS) documentation, including Design History Files (DHFs) and Corrective and Preventive Actions (CAPAs). Audits & Reviews: Support internal and external audits, manage supplier qualifications, and oversee training and calibration programs. Cross-functional Support: Provide critical quality support for product development, drive quality improvements, and ensure ongoing regulatory compliance.
Posted 3 weeks ago
10.0 - 14.0 years
0 Lacs
indore, madhya pradesh
On-site
Requirement Injectable and Ophthalmic R&D. Department: Development QA. In Complex injectable and ophthalmic drug products for regulated market Total Experience required - 10 to 14 years Qualification: M.Pharm Job Location:- R&D, Rau, Indore, M.P Company: Knovea pharmaceutical, Pvt. Ltd Below is the Job description for the DQA position, To participate and execute the quality management system for R&D centre. To participate & ensure the documents issuance, retrieval, archival and obsoletion of documents. To facilitate quality culture, good documentation practices for R&D related activities. To develop training modules and organize and conduct training sessions for R&D functions. To maintain and execute Quality Management System related to (Change control, Incidents, CAPA, Effectiveness review, Calibration management) Assigning project and document numbering for R&D projects as applicable. Review and approval of protocols/reports for Equipment/instrument Qualification, Stability studies or any product related studies etc. Standard operating procedures (SOP) preparation/review/approval/distribution and archival. Issuance of calibration formats/annexures, SOPs, Specifications/MOA, Equipment/Instrument logbooks and other controlled documents to user. To ensure compliance for calibration/PM & instrument qualification activity in Analytical and Formulation Labs for R&D. To review and approve the technology transfer document and product development report/specification and other technical documents etc. for R&D. To plan and conduct the Internal Audits and act as a facilitator for External Audits for R&D. Ensure compliance for current SOPs, policies, and ICH guidelines and country specific regulatory requirements. Proficient in Microsoft Office (Excel, Word, Outlook & Teams) is an added advantage. Note : AQA/Lab QA experience in Ophthalmics/Injectables can also apply. Interested candidates can DM me and share a CV dipesh.dey@knovea.com,
Posted 3 weeks ago
3.0 - 5.0 years
2 - 5 Lacs
Kolkata
Work from Office
Strong knowledge of FDA QSR, ISO 13485, EUMDR & regulatory norms. Manage QMS docs, DHFs, CAPAs, audits, suppliers, training & calibration. Support audits, product dev, quality improvements & regulatory compliance. Excellent doc & comm skills needed.QMS Management: Oversee and manage essential Quality Management System documentation, including Design History Files (DHFs), CAPAs (Corrective and Preventive Actions), and change controls. Regulatory Compliance: Ensure strict adherence to FDA QSR (21 CFR Part 820), ISO 13485, EUMDR (EU Medical Device Regulation), and other relevant regulatory norms. Audit Support: Actively support internal and external audits (e.g., FDA, Notified Body), ensuring readiness and effective follow-up. Supplier Quality: Manage supplier qualification, monitoring, and quality agreements to ensure materials and services meet specifications. Training & Calibration: Coordinate and maintain training records and calibration programs to ensure compliance and operational effectiveness. Quality Improvement: Collaborate on product development initiatives and drive continuous quality improvements across the organization.
Posted 1 month ago
5 - 8 years
7 - 10 Lacs
Bengaluru
Work from Office
MANUFACTURING ENGINEER II At TE, you will unleash your potential working with people from diverse backgrounds and industries to create a safer, sustainable and more connected world. Job Overview TE Connectivity's Manufacturing Engineering Teams are process leaders for stamping, molding or assembly related topics, ensuring the processes are running at optimum levels for quality and output. They are experts in mold tooling, die tooling, machining, and assembly techniques, possessing extensive knowledge of the associated manufacturing processes which may include the optimization and standardization of stamping / molding / assembly or other processes within the manufacturing environment. Manufacturing Engineering Teams enable the TE business unit plants to reach TE Operating Advantage (TEOA) requirements, roll out Centers of Excellence (COE), Best Demonstrated Practices (BDPs) and advise plants on tool and machine duplications / corrections / improvements. They design and develop manufacturing process and automation platforms and apply them for the realization of new product developments as well as optimization of existing products already in production. The Teams also support Product Development in the selection and optimization of tools for piece part production and the selection of the most suitable manufacturing concepts relative to planned manufacturing quantities, quality requirements and manufacturing location. They act as interface between engineering and production to ensure manufacturability of new designs and smooth production ramp up as well as support the research & development teams to produce sample manufacturing equipment, product samples and prototypes. Responsibility: Analyze new technology and manufacturing processes. Plan and assess the feasibility of new and running automation projects. Troubleshooting skills and failure analyses for resolving problems of electrical and electronics, pneumatics and Hydraulics devices like Servo, PLC, HMI, Pneumatics. Hands on experience in robotic installation, commissioning. Implementing digital factory, cloud-based systems, AI Vision, AR/VR, IOT, Industry 4.0, Machine connectivity, Traceability Systems through wi-fi as well as wired network. Vendor management, Installation, and commissioning of new Equipments and co-ordinate with Vendor/CFT for complete process validation. New project conceptualization, Design, and development and machine buy-off and qualification. Develop new process and create all process documents like PFC, PFMEA, Control plan and SOP by understanding the depth of product requirements Prepare CT & Investment for new product and always work on to reduce cost by optimization/automating process to reduce cost. Responsible for ordering spares and vendor management, down time reduction Capacity & Layout planning/execution for new product line. Support manufacturing for Continuous Improvement, quality issues on the floor, new launches, engineering changes and Lessons Learnt. Develop and implement systems that optimize all phases of production process. Conduct Root-Cause Analysis. Review designs for manufacturing feasibility, suggest changes to the design to ensure product cost effectiveness Establish Tool management System (TMS), Calibration management, Document management Systems like Vicidocs, IQ-RM, Etc. Implement Process monitoring and Control (SPC & SQC), quality traceability Systems using IOT technology. Create, Maintain & Control all the programming softwares and production control documents for anytime ready for Auditing. Hands on experience on mechanical 3D design softwares like Creo, Pro-e or Solid works Desired Candidate Profile: EDUCATION/KNOWLEDGE BE/ B. Tech (Mechatronics, Electrical/Electronic or Mechanical/Instrumentation) Or Diploma with Good experiences. Knowledge on Connector & Harness is added advantage. 5~8 years related industry experience with good communication, stakeholder management. & Project management skills will be idealCRITICAL EXPERIENCE Should have worked in assembly industry with minimum 5+ years of experience in execution of automation projects and vendor management Experience in quality & productivity improvement projects (TPM) Experience in automation/robotics project execution and SPMsCOMPETENCIES Operational ExcellenceAbility to create strategy maps (X-Matrix) for manufacturing engineering function to meet plant goals, implement and execute actions as per the X-matrix. Industrialization focusCapability to work with cross functional team for planning, executing activities related to NPD / NPT within the timeline defined by Project dept. Quality OrientationAbility to understand process requirements, define quality standards, resolve problems relating to form fit functions. Stakeholder managementCapability to liaison and influence quality, production engineering and projects teams; work cross functionally in line with overall goals Talent managementManaging experienced professionals, assuring succession & workforce planning, resource allocation & organizational capability Competencies ValuesIntegrity, Accountability, Inclusion, Innovation, Teamwork Compensation Competitive base salary commensurate with experience (subject to change dependent on physical location) Posted salary ranges are made in good faith. TE Connectivity reserves the right to adjust ranges depending on the experience/qualification of the selected candidate as well as internal and external equity. What TE Connectivity Internship Program offers TE has a robust internship program that provides our interns with an abundance of resources to feel included as part of our Team. Every summer we coordinate various educational and networking events for our interns. The TE University Relations team will be hosting virtual meetups, information sessions, tours, skill building presentations, and topping it off with National Intern Day celebration activities. A unique employee resource group we have is the Young Professionals Employee Resource Group (ERG). This group is committed to creating a highly engaged and empowered cross-functional network of young professionals by placing high value in Professional Development, Networking Opportunities and Community Involvement to drive the success of our interns. In addition to the ERG, we also provide our interns with complete access to our internal library of self-lead courses. These courses include academies like leadership to help the interns develop their development in becoming future leaders at our organization. To help with their professional growth, we provide access to Mentors via our NAVIGATE platform. Mentors serve as a guide to navigate the organization and provide additional support in their career endeavors at the company. Our program provides a holistic experience for interns that targets professional development and personal growth. Our internship program typically runs May thru August and gives students the opportunity to work on projects that contribute to the success of their team and build on their classroom experience. Throughout the 1012-week program, interns will be provided with Onboarding & Orientation Professional Development Workshops Networking Opportunities Operations Experience Executive Exposure Timeline TE Connectivity recruits on campus between September and March for New Grad (FT), Rotational, Internship and Co-op positions beginning in May. Once you have applied to a position, your resume and application will be reviewed. If you are selected to move to the next step in the application process, you will be contacted by a recruiter. Once you accept an offer, the onboarding process will begin in January for interns who have committed to offers in the fall semester and upon acceptance for interns who have committed to offers in the spring semester.
Posted 2 months ago
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