5 Control Plans Jobs

The New Product Manufacturing Engineer (NPME) is responsible for ensuring smooth and compliant transition of new medical devices from design to manufacturing. This role plays a critical part in developing scalable, validated manufacturing processes, driving design for manufacturability (DFM), and executing Verification and Validation (V&V) activities in alignment with ISO 13485 and FDA 21 CFR Part 820. Key Responsibilities: Collaborate with R&D during the design phase to influence DFM and ensure manufacturability. Plan, execute, and document manufacturing Verification & Validation (V&V) activities, including equipment and process validations (IQ, OQ, PQ). Lead development of process documentation: PFMEA, control plans, work instructions, SOPs, and batch records. Develop manufacturing strategies, assembly procedures, and pilot line setups for new product introductions (NPIs). Drive tooling, fixture design, and automation planning for scalable and cost-effective production. Support and lead design transfer activities from engineering to manufacturing, ensuring production readiness. Participate in clinical builds and first article inspections (FAI), ensuring traceability and documentation compliance. Use statistical methods to analyse process capabilities and implement continuous improvements. Lead root cause investigations for manufacturing issues and support CAPA implementation. Collaborate cross-functionally with Quality, Regulatory, Supply Chain, and Production teams to ensure product launch timelines are met. Provide input and support for regulatory submissions related to manufacturing process and V&V outcomes. Qualifications: Bachelors degree in mechanical, Manufacturing, or Industrial Engineering. 5+years of experience in medical device manufacturing, new product introduction (NPI), and process development. Strong knowledge of Verification & Validation (V&V) principles and experience with IQ/OQ/PQ protocols. Familiarity with ISO 13485, GMP, and FDA 21 CFR Part 820. Proficiency with CAD (e.g., SolidWorks), ERP systems (e.g., Odoo, SAP), and statistical tools (e.g., Minitab, JMP). Demonstrated ability to write and review technical documentation for audits and regulatory submissions. Preferred Skills: Experience in Class II/III medical device product launches. Exposure to cleanroom practices and ESD-safe assembly. Hands-on experience in FMEA, and process optimization.

Manager – QA & QC with 6–9 yrs in automotive QA/QC, audits, SPC, MSA, NPD, IATF, AS9100D. Strong leadership, documentation, and supplier/customer handling. BE Mechanical/Electrical. Preference for Kannadiga candidates. Location: Kanakapura.

4–6 yrs experience in automotive component manufacturing. Must know IATF, AS9100D, SPC, MSA, FMEAs, and audits. BE in Mechanical/Electrical. Preference for Kannadiga candidates with strong problem-solving and communication skills.

Role & responsibilities Quality Assurance Engineer: Ensure compliance with FAI, PPAP, control plans, and quality procedures. Ensuring compliance with AS9100, ISO 9001, AS13100, and other customer specific requirements. Risk should identify upfront, Develop, implement, and monitor quality control processes to ensure product conformity. Conducting Process Capability Studies in FAI & Production stage with SPC (Cp, Cpk, GR&R, MSA) Implement in quality gauges & mistake-proofing techniques.( like gauge & position gauges., etc) Identify and address non-conformances (NCRs) and escapes, implementing Permanent corrective actions Preferred candidate profile Implementing AI-based vision systems, CMM automation, and inline inspection technologies Experience with CMM, GD&T, SPC, NDT, and metrology tools. Proficiency in quality tools like 8D, 5-Why, 7-QC tools, DMAIC, and PFMEA. Strong analytical, problem-solving, and communication skills. Qualifications & Experience: BE/B. Tech/Diploma in Mechanical (Mechanical, Aerospace, Industrial, or equivalent). Minimum 5 years of experience in Quality Assurance in aerospace manufacturing. Perks and benefits Statutory benefit such as Bonus, Gratuity, Insurance, Canteen and Transportation Contact Person : Manoj - 8618656208

Location: Ganapathy Maa Nagar, Coimbatore Note: The candidate should be willing to travel to customer place and work. Must have Two-wheeler Key Responsibilities: Conduct Gap Analysis : Perform a thorough gap analysis to evaluate clients' existing processes against ISO 9001 requirements, identifying areas for improvement. Develop and Implement QMS : Design and implement ISO 9001:2015 compliant Quality Management Systems (QMS) tailored to clients' needs. Guide Through Certification Process : Support clients through every stage of the ISO 9001 certification process, including preparation and audit assistance. Provide Training & Awareness : Conduct training sessions to enhance client understanding of ISO 9001 principles, processes, and documentation. Document Preparation & Review : Assist in the preparation and review of key documents such as quality manuals, procedures, work instructions, and process maps. Audit Support : Conduct internal audits and provide support during external certification audits to ensure compliance with ISO 9001 standards. Continuous Improvement : Identify improvement opportunities within client operations and provide recommendations for ongoing enhancement. Ensure Compliance : Stay current with ISO standards and ensure that clients adhere to the latest ISO 9001:2015 requirements. Cross-functional Collaboration : Work closely with cross-functional teams to seamlessly integrate QMS into day-to-day business operations. Ongoing QMS Maintenance : Assist clients in maintaining and continually improving their QMS post-certification. Qualifications & Skills: ISO 9001 Internal Auditor Certification : Certification as an ISO 9001 Internal Auditor or an equivalent qualification. Audit Coordination Experience : Proven experience in coordinating Management System certification audits. Industry Experience : Background in quality control, particularly within the machining/fabrication industry or similar sectors. ISO 9001 Knowledge : In-depth knowledge of ISO 9001 standards, quality tools, and methodologies. Quality Improvement Techniques : Experience implementing Kaizen, Poke Yoke, and other quality improvement techniques. ISO 9001 Implementation & Auditing : Strong track record of implementing and auditing ISO 9001 Quality Management Systems. Quality Management Expertise : Comprehensive understanding of quality management principles, methodologies, and tools. Project Management & Communication Skills : Excellent project management, communication, and presentation skills. Analytical & Improvement Focused : Ability to analyze complex processes and provide actionable recommendations for improvement. Documentation & Reporting : Proficiency in preparing documentation and reports in compliance with ISO 9001 requirements. Independent & Team Collaboration : Ability to work independently as well as collaborate effectively with teams. Problem-Solving & Attention to Detail : Strong problem-solving abilities with keen attention to detail.