• Store Assistant - Tool Room
    Tool Room
    Bangalore India
    The Store Assistant - Tool Room is responsible for maintaining the Toolroom stores and handling the material inward, outward and material issue and receipts. This position requires good communication skills, eye sight, ability to working rotating shifts and to travel as necessary. Key Accountabilities/Essential Functions 1. Read the drawing / document for material issue 2. Maintain the minimum / maximum stock keeping of consumables and raw materials 3. Preparing the material outgoing and incoming documents for parts/material movements 4. Getting the quotes for the regularly maintained items in the tool room stores 5. Prepare the purchase requisitions and other purchasing documents for Raw material/Standard parts/Consumables procurement 6. Follow up for the local procured items and ensure that we meet the delivery requirements 7. Preparing the PO, GRN, tracking documents (Annexure),month end closing, handling inventory following vendor payments Compiling of the procurement/invoice documents and moving to finance after getting the department approval 8. Maintain the back up of all transactions in a clear excel sheets and update the same regularly 9. Ensure that every month/at any given point of time the book stock matches the physical stock in the stores. Monthly/Quarterly/Half yearly & Annual stock taking of the inventory Other Position Duties Reporting the daily/monthly utilisation report of the machine Technical/Functional Skill Sets At least 2 to 3 years of working experience in Stores/Warehouse department in manufacturing environment and related field. Basic computer skills Aware of ERP software like Tally, SAP etc. would be added advantage  
  • Quality Inspector
    Bangalore India
    The Quality Inspector maintains quality standards by sampling, inspecting & labeling (physical & mechanical checks & tests) of incoming materials & components as used in the manufacture of molded parts, sub-assemblies & finished medical devices as per control plans, SOPs & WIs.  Assures accuracy & correctness of data & maintains inspection results in Device History Records for release of goods. 1. Performs receiving inspections (visual, dimensional & functional) on incoming raw materials, packing materials & components purchased, as per defined specifications &/or as per supplier certificates, so as to assure that they are within the acceptance criteria & approves them by labeling. 2. Rejects nonconforming materials & components by segregating, labeling & quarantining the lots. Communicates & reports the nonconformity to stores personnel &/or supplier as appropriate for necessary disposal action & corrective actions. 3. Performs monitoring of key process inputs & process variables & communicates the shop-floor process adjustments, as may be required, to the appropriate production personnel & work with them. 4. Performs in-process inspections (in-depth visual, dimensional & functional) on components being produced &/or packed in the prescribed packing materials, as per defined specifications, so as to assure that they are within the acceptance criteria &/or as per customer requirements & approves them by labeling & signing off. 5. Rejects nonconforming components & sub-assemblies by segregating, labeling & quarantining the lots. 6. Participates in new product developments & process validation per protocols. Reads & perform first article inspection (FAIR) as per drawings using inspection guide sheets & standard & custom gages. 7. Performs inspections on finished products before they are packed in cartons, stored & palletized for shipping, as per defined specifications &/or as per customer requirements, so as to assure that they are within the acceptance criteria & approves them by labeling. 8. Rejects nonconforming goods by segregating, labeling & quarantining the impacted packaging units as per procedure. Communicates & reports the nonconformity to production personnel for suitable corrective actions. 9. Monitor & maintain the critical equipment & instrumentation to ensure proper operation & calibration. 10. Coordinate periodical calibration of all measuring & monitoring devices & fixtures. 11. Supports investigating root cause analysis & corrective & preventive actions for customer complaints. 12. Control of QMS documents & retention of records. 13. Documents inspection results by completing reports & logs; summarizing re-work & waste; inputting
    1. data into quality database.
    2. Perform review of Device History Records & other documentation for compliance to established procedures & Good Documentation Practices.
    3. Keeps measurement equipment operating by following operating instructions.
    4. Maintains safe & healthy work environment (cleanroom) by following standards & procedures; complying with legal regulations.
    5. Understands guidelines, regulations (current updates) & GMP (Good Manufacturing Practices) Requirements – USP/ EP; USFDA 21CFR, CE Marking, EU Directives to assure that the products meet market government standards & safety regulations.       Assists in regulatory stewardship support to corporate regulatory team.
    6. Assist in the writing & updating inspection procedures, protocol & checklists.
    Evaluate problems & make initial recommendations for possible corrective action to supervise. Requirements
    1. Quality inspection of plastics injection molded & assembled medical devices.
    2. Quality Management Systems (QMS) Requirements (QA / QC) – preferably ISO 13485.
    3. Electronic Document Control; BOM review; Medical Devices - Risk assessment & risk control techniques.
    4. Good mechanical aptitude, arithmetic, analytical quality engineering & technical process engineering experience in trouble shooting & process improvement.
    General proficiency in computer applications like Minitab, MS Word, Excel, PowerPoint, Outlook, etc.  
  • Quality Engineer
    Quality Engineering
    Bangalore India
    The Quality Engineer reports to the Asst. QA Manager and working collaboratively with other departments to define and execute functional and operational objectives. Key Accountabilities and Essential Functions 1. To ensure Raw Material/Packing Material and finished goods testing in line with the SOPs 2. To maintain Device history records & Product releases for each lots 3. To conduct inspections at in-process, in-coming and completes the final inspections 4. To prepare technical documents like DMR & DHR 5. To maintain Microbial record in ISO class 7 & class 8 as per procedure 6. Creating Master documents to track calibration & latest version of documents and records 7. To prepare control plan, FMEA & FAIR documents. 8. To prepare 8D and supplier CAPA reports 9. Monitoring Calibration activities 10. Perform Metrology activities & Drawing reviews 11. Coordinates investigation, root cause analysis & corrective action Requirements 1. Various metrology equipment, VMS & CMM 2. Product & Process validation requirements & implementation 1. Gauge R&R, CpK, PpK studies, IQ, OQ,PQ validation/qualification, MSA, Run charts…etc 2. Working knowledge of the ISO 13485:2003, ISO 9001:2008 standards 3. FAIR inspection, DHR & control of documents