Contacts: This position interacts with all levels of employees & suppliers (& internal customers) appropriately. Position Scope & Purpose: 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. Key Accountabilities/Essential Functions: Performs receiving inspections (visual & dimensional) on incoming raw materials, packing materials & components purchased, as per defined specifications. 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. Performs in-process inspections (visual & dimensional) on components being produced &/or packed in the prescribed packing materials, as per defined specifications. Rejects nonconforming materials & components by segregating, labeling & quarantining the lots. Communicates & reports the nonconformity to supervisor. 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. Performs inspections on finished products before they are packed in cartons, stored & palletized for shipping, as per defined specifications &/or as per customer requirements. Monitor & maintain the critical measuring equipment & instrumentation to ensure proper operation. Coordinate periodical calibration of all measuring & monitoring devices & fixtures. Supports investigating root cause analysis & corrective & preventive actions for customer complaints. Control of QMS documents & retention of records. Documents inspection results by completing reports & logs; inputting data into quality database. Maintains safe & healthy work environment (cleanroom) by following standards & procedures. Assist in the writing & updating inspection checklists & reports. Evaluate problems & make initial recommendations for possible corrective action to supervise. Technical/Functional Skill Sets: Quality inspection of plastics injection molded & assembled medical devices. Quality Management Systems (QMS) Requirements (QA / QC) – preferably ISO 13485. 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. Personal Qualities/Characteristics required for the position: While performing the duties of this job, the employee is regularly required to stand; walk, & sit for extended periods of time. Should be willing to work in night shifts & weekends. The above statements are intended to describe the general nature and level of work being performed by the incumbent(s) of this job. They are not intended to be an exhaustive list of all responsibilities and activities required for the position. This job description will be reviewed periodically as duties and responsibilities change with business necessity. Essential and other job functions are subject to modification. #IND Show more Show less

Working knowledge of measuring devices like vision Measurement System, Co-ordinate Measuring Machine, Video Measurement Machine, Digital Caliper, Micrometer, Height Gauge etc.. Reviewing of product requirements and specifications such as drawings. Preparing inspection plans, performing metrology activities and preparing FAI reports. Participating in FMEA / Control plan reviews and preparing FAI reports. Conducting the measurement system analysis (Gage R&R and attribute agreement studies). Issuance and retrieval of documents per control of documents procedure. Maintaining the calibration status of the measuring equipment by periodical tracking. Inspection of incoming raw materials, buyouts & packing materials per receiving quality plans. Issuing supplier corrective actions requests (SCAR) and controlling the supplier non conformities. Performing particle count testes & monitoring of bioburden tests for control of cleanrooms. Performing final inspections of pecked finished goods for product release. Inspection of products at start-up, in-process & end-up stages of production. Maintaining the manufacturing and inspection records in device history records (DHR). Participating in the investigation of nonconformities, such as root cause analysis. Preparing 8D report and implementing the corrective and preventive actions. Identifying & retaining the records per control of records procedure. Knowledge in programming of CMM & VMM inspection software and associated experience. Knowledge in the process qualification requirements (IQ, OQ & PQ) & experience in validation. 19 Experience in the use of tools of Minitab software such as measurement system analysis (Gage R&R and attribute agreement studies), process capability studies (CpK & PpK),etc.. Working knowledge & experience in implementation of the ISO 13485 standard. #IND Show more Show less

Design and develop high-precision molds for plastic injection molding, ensuring adherence to customer specifications and industry standards. Generate/computer 3D design and 2D detailed prints injection molds & fixtures. Prepare the layout and concept for supporting the estimation activities. Review and prepare the necessary documents/presentation for DFM. Co-ordinate with customer & tool shop for getting the mold build to meet the required specification. Analyze the part drawing to understand the feasibility of maintaining the dimensions in the part while molding. Co-ordinate with toolroom, Engineering, Molding & quality department to ensure and prove the mold design/built. RFQ for Mold base and other standard elements preparation. Electrode design and creation of drawings for machining. Coordinate with the tooling team to review mold designs and implement necessary revisions. Ensure that mold designs meet safety, quality, and cost parameters while adhering to project timelines. Support root cause analysis and troubleshooting for any molding defects or issues in the production process. Collaborate with customer/suppliers to select appropriate materials and components for mold fabrication. Manage multiple projects and work effectively in a fast-paced, collaborative environment. Reporting the daily/monthly utilization report of the job. Good documentation skills to maintain the relevant documents up to date for audits. 3D CAD software (Preferably Solidworks), AutoCAD, Microsoft Office Tools & Moldflow Analysis Knowledge of various injection molding processes (2 plate, 3 plate, Hot runner, Hot sprue, insert molding, overmolding, unscrew mold, vertical molding etc.). Thorough understand part geometry, Moldability, Capability Studies & Tolerance analysis. Familiarity with industry standards (e.g., ISO, ASTM) and quality management systems (e.g., ISO 9001). Strong understanding of material properties, mold construction, tooling and machining processes. #IND Show more Show less

the candidate should be capable to handle Storage of the Materials using Pallet Jack Trolley and Forklift, driving license valid for forklift driving preferred, Labeling Machine, Weighing Machine etc.. Verifying and Receiving of Materials as per the Purchase Order of SMC and Invoice/Delivery Challan of the Supplier. Issuing of Raw Material from store to the Production as per the Material request given by the Department. Issuing of WIP Components, Packing Items, and semi finished goods for Assembly Department on FIFO Basis. Inward of WIP Components to Store from Production Department. Maintaining a statement of Bin Card Entries for Raw Materials, FG Components, WIP Components, Packing Items and Semi Finished Goods. Maintenance and Issuance of Consumables and Gowning items as per the Material Request given by the Departments. Preparation of Purchase Orders as per the Material Request (MR) and Service Request (SR) Given by Departments. Creation of Goods Receipt Notes for Materials received Through Invoice/Delivery Challan. Preparation of Job work Challan as per the Request given by Tool room and making entry of the same in the Annexure-10 Register. Preparation of Physical Inventory of the stock. Maintenance of Process Rejection of the Molding and Assembly Department. Additional task assigned by the Management to time to time. Crushing of Rejection parts through granulator and storage of the same for scraping. #IND Show more Show less

Responsible for production (Device assembly and packaging) based on the schedules. Run production machines, assembly the product as per the work instructions. Responsible for preparing and maintain daily production records as per QMS requirements. Assist the production supervisor/Leader in achieving production targets. Follow the company policies, safety rules and other production related procedures. Maintain a clean and safe work area. Perform other related duties as and when assigned. Have the ability to inspect quality of own work done. Maintain cleanliness & 5s in the production/work area. Assist in the maintenance activities of tooling and equipment used in assembly. #IND Show more Show less

Interact with the supervisor in order to understand the production schedule. Plan the days production activities based on the supervisor’s instructions. Collect data sheet, machine instructions and work manuals. Ensure availability of consumables and materials for production. Collect the per-heated pellets and raw material in granular form. Add the raw material in the machine using material loader or by manual feeding. Add he raw material in the machine using material loader or by manual feeding. Run the machine and visually inspect sample manufactured comparing to mastr sample or first part approved sample kept on operating table. Count rejections and accepted products during every operating hour. Do all necessary post molding operation during the cycle time run such as trimming, apply protective tapes, putting labels on each product for identification. Clean and maintain the machine at regular intervals as per maintenance schedule. #IND Show more Show less

Equipment Used: Injection molding machines (Arburg, Engel, Batten field, Nissei, Fanuc Roboshot, etc.) CNC milling machines (Mazak, Makino, DMG Mori, etc.) EDM machines (AGIE, Sodick, etc.) Surface grinders (Okamoto, HMT, Proth, etc.) Utility equipment like transformers, electrical switchgear, diesel generators, air handling units, air compressors, sewage treatment plants, UPS, PLCs, etc. Key Accountabilities/Essential Functions: Carrying out routine scheduled maintenance work and responding to equipment faults. Designing maintenance strategies, procedures and methods. Provide accurate information and regular progress updates as required by management. Undertake any training as required and ensure working knowledge is kept current. Keep accurate records of all testing, checks, observations as required. To update spares list and monitor stock levels. Diagnosing breakdown problems. Monitoring and controlling maintenance costs. Prepare ISO documentation and good knowledge on GMP. #IND Show more Show less

Experience in handling Injection molding machines like Arburg, Engel, Battenfield, Nissei & Roboshot; Mold temperature controllers like tool temp; Desiccant drying systems like Matsui; Hot runner systems like mold master, Husky. Interact with the supervisor in order to understand the production schedule. Plan the days production activities based on the supervisor’s instructions. Collect data sheet, machine instructions and work manuals. Ensure availability of consumables and materials for production. Collect the pre-heated pellets and raw material in granular form. Add the raw material in the machine using material loader or by manual feeding. Add he raw material in the machine using material loader or by manual feeding. Run the machine and visually inspect sample manufactured comparing to master sample or first part approved sample kept on operating table. Count rejections and accepted products during every operating hour. Do all necessary post molding operation during the cycle time run such as trimming, apply protective tapes, putting labels on each product for identification. Clean and maintain the machine at regular intervals as per maintenance schedule. Prepare ISO documentation. Good knowledge on GMP Reporting the daily/monthly utilization report of the job. #IND Show more Show less

Working knowledge of various metrology devices like Vision Measurement System (VMS), Co-ordinate Measuring Machine (CMM), Vernier Caliper, Micrometer, Comparator, Height Gauge, etc. Develop and establish quality procedures & shift schedules for inspectors for testing of products in all stages of manufacturing. Review product drawings, classify all the probable nonconformities into various risk categories & define a control plan (inspection & lab test methods & sampling frequency, sample size & AQL) for all. Interact with engineering function on FMEA & inspect & review engineering releases, adhering to strict guidelines on quality risk management methods. Perform process audits, product audits & internal quality audits and report the findings. Maintain a CAPA log record, follow up on open CAPAs, and update. Train quality engineers, inspectors & operators on updated work instructions & quality control methods and guide them on measurement (metrology) methods. Work with the production team to implement testing criteria or assembly methods developed. Organize incoming inspection of raw materials & bought-out parts, an in-process inspection of items & final inspections of finished products as per defined frequencies. Conduct supplier audits, and monitor supplier quality performance & corrective actions if any. Monitor cleanroom conditions by organizing external testing as per AHU re-qualification procedures. Maintain the list of monitoring and measuring devices, schedule & organize periodical calibration. Facilitate successful qualification/validation of processes in product development (IQ, OQ, & PQ), record the results & document them as applicable & as defined by the customer for all the phases. Perform gauge R&R, process capability studies, etc. to meet quality deliverables. Identify & retain customer-approved samples, control samples & defect limit samples if any. Oversee cleanroom activities by daily rounds to ensure that the production & assembly processes adhere to the planned controls and critical process parameters. Compile all the documents into respective Device Master Records. Review and maintain the inspection logs production and quality records daily. Review the Device History Files (DHF - for defect incidences, if any) & make certificates of analysis /or conformity to recommend product releases. Organize to collect samples, check for visual (physical) defects, e.g. color, texture & strength & locate imperfections; measure control dimensions. Periodically monitor, review & update the inspection & testing procedures, improvement is required. Find the root causes of defects & develop creative solutions using problem-solving techniques. Provide timely feedback to engineering & production regarding product non-conformity & ensure timely disposition of non-conforming products and closure of NCMRs. Ensure that changes & deviations, if any, are documented and are approved prior to implementation. Perform the tasks as may be required from time to time as assigned by the management. Strong attention to detail & documentation & the ability to provide professional & technical support. #IND Show more Show less

Equipment Used: Injection molding machines like Arburg, Engel, Battenfield, Nissei & Roboshot. Tool room machines CNC mill Mazak, AGIE; EDM machines like AGIE, Fanuc, surface grinder etc.. AHU STP Compressor and DG All utility equipment's. Key Accountabilities/Essential Functions: Responsible for the completion of all maintenance service requests as assigned. Schedule and complete the “Preventative Maintenance Program”. Assist in monitoring all work being performed by outside contractors. Responsible for 24-hour emergency maintenance service as scheduled. Responsible for alerting the property the property manager of any unusual occurrence and/or damage that have taken place or that may occur. Ensure safety standards are followed which comply with all company, local, city, state and national guidelines. Performs minor plumbing maintenance (eg. replacement or repair of leaks in drains and faucets, unclogging of drains,, trenching and laying new lines, replacing drain hoses on washers and similar devices, etc…) Performs minor painting, carpentry and masonry work (e.g. preparing surfaces and using brush, sprayer, or roller to apply paints, stains, and varnishes, hanging doors, fitting licks and handles, etc..) Performs other work related duties as assigned. Must be able to work flexible hours. Prepare ISO documentation & Good knowledge on GMP. #IND Show more Show less

Working knowledge of various metrology devices like Vision Measurement system (VMS), Co-ordinate Measuring Machine (CMM), Vernier Caliper, Micrometer, Height Gauge, etc.. Performs receiving inspections (visual & dimensional) on incoming raw materials, packing materials & components purchased, as per defined specifications. Performs monitoring of key process variables & communicates the shop-floor process adjustments, as may be required, to the appropriate personnel & work with them. Performs in-process inspections (visual & dimensional) on components being produced &/or packed in the prescribed packing materials, as per defined specifications. Rejects nonconforming materials & components by segregating, labeling & quarantining the lots communicates & reports the nonconformity to supervisor. 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. Performs inspections on finished products before they are packed in cartons, stored & palletized for shipping, as per defined specifications &/or as per customer requirements. Monitor & maintain the critical measuring equipment's & instrumentation to ensure proper operation. Coordinate periodical calibration of all measuring & monitoring devices & fixtures. Supports investigating root cause analysis & corrective & preventive actions for customer complaints. Control of QMS documents & retention of records. Documents inspection results by completing reports & logs; inputting data into quality database. Maintains safe & healthy work environment (cleanroom) by following standards & procedures. Assist in the writing & updating inspection checklists & reports. Evaluate problems & make initial recommendations for possible corrective action to supervise. Quality inspection of plastics injection molded & assembled medical devices. Quality Management System (QMS) Requirements (QA / QC) - preferably ISO 13485. 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.. #IND Show more Show less

Planning and execution of processes, activities in Marketing, New product development, Sales & Customer services functions. Key Accountabilities/Essential Functions Assist in preparing market plans and strategies to promote company’s products Prepare effective presentations on business development opportunities Inform superiors on identified business opportunities Develop good customer relationship by personal visits, phone call, follow ups, emails etc Maintain strong relationship with customers for future business growth Assist in preparing quotations Work with internal teams to achieve targeted business goals Assist in conducting trade shows & other marketing campaigns Assist in preparing the invoicing & dispatching activities Updation of Sales & Marketing documentation to meet QMS requirements Effectively communicates relevant project information to superiors Regular updation of quote log sheets Updating of sales order in Tally Other Position Duties Participate in regular meetings with team and provide periodical reports On need basis, travel to other SMC plants for providing technical support Visit prospective suppliers based on specific project requirements Technical/Functional Skill Sets Basic knowledge of plastics engineering and/or medical devices Commercial acumen Personal Qualities/Characteristics Required For The Position Good written and communication skills Good presentation skills Good negotiation skills Strong work ethic Strong people management skills #IND Show more Show less

Key Accountabilities/Essential Functions: Initiating and leading production startups and change overs. Trouble shooting of the injection molding process. Planning and executing resin and tool changes based on production schedules/trials. Participating in continuous improvement initiatives that support production efficiency, scrap reduction, Proving of new tools and alternative material evaluation. Generating daily production documentation including end-of-shift production/scrap reports and collection of process control data. Maintaining and practicing safe working habits and participating in safety initiatives. Performing general tasks including but not limited to placing/removing/adjusting auxiliary equipment, greasing, inspecting, adjusting lubricant levels, etc.. Thorough understanding of scientific molding concepts. Preparing ISO documentation. Should be able to handle the shift. Good knowledge of GMP Other Position Duties: Ready to work in shifts in rotational basis. Technical/Functional Skill Sets: Injection molding, post molding operations, injection molding process development, validation, troubleshooting, CAPA, GMP, clean room management, safety procedures, shift management, material handling, industrial relations, management reporting. Show more Show less