SIMALJIT KAUR
Morrisville,NC
Summary
Committed and motivated manufacturing cleanroom professional with over 13 years of experience in the medical device industry. Demonstrated expertise in ensuring clean and sterile environments to meet stringent quality standards. Adept at operating and maintaining specialized equipment, while consistently delivering exceptional customer service. Proven track record of effectively collaborating with cross-functional teams to achieve production goals and optimize workflow efficiency.
Overview
24
24
years of professional experience
Work History
Senior Cleanroom Tech
Carolina Components Group
09.2021 - Current
- Follow gowning and de-gowning procedure
- Count all the parts and check tubing lengths prior assembling building
- Push jobs inside the cleanroom, manage 7-8 employees
- Lead the team by assigning job duties
- Work on expedited, sterile and non sterile jobs
- Perform the First Article Inspection before building the whole assemblies
- Responsible for assembling, testing, inspecting, and packaging single-use assemblies using various assembly equipment, tools, and test equipment
- Batch assembly records, and associated procedures within a controlled environment assembly setting
- Move jobs in the Acumatica system, perform cleaning, bagging and sealing the parts
- Consistently follow processes and procedures to operate compliantly within a controlled environmental manufacturing space
- Read and Understand Assembly drawing and assembly instructions to correctly and efficiently assemble products
- Distinguish differences in sub-component parts based on part number and visual inspection
- Performs labeling and packaging activities
- Interact with Quality Assurance personnel to ensure product quality and address any non-conformity detected
- Report problems with quality, processes, equipment, or materials to the Team Lead and or Supervisor
- Complete line clearance, scrap records, training records, and other documentation as required
- Maintain a clean and organized work area to facilitate manufacturing functions
- Other duties as assigned by the Supervisor and or Team Lead
Production Technician
3Shape
07.2019 - 08.2020
- Assembly of 3shape products, which include inter-oral and laboratory scanners
- Testing of electronics, mechanical, and optical parts that are used during assembly process
- Insert images and run updates on the PC's
- Assure high quality of produced goods
- Realization of production goals
- Work according to production instructions, compliance with production control, write adequate notes in documentation
- Training co-workers according to production instructions
- Run test in 3Shape software - calibration of the scanner
- Assemble components used in production by hand and with the use of tools such as welders and drills
- Participate in and implement continuous improvement processes and tasks related to service and repair
- Proven work history showing dependability, a strong work ethic and stability in previous positions
- Ability to multi-task and approach tasks with detail-oriented manner
- Ensure work station is clean, properly equipped and free from hazards and distractions and ability to adhere to all safety guidelines
- Enter all the paperwork in computer using Ax web
- Final inspection, make labels and prepare paperwork for shipping the medical devices
- Also getting cross training in different departments
- Stock supplies, heavy lifting of scanners and pcs, packaging and fill out all the forms
- In-depth understanding of cGMP compliant production and documentation
- Able to function in a fast-paced team environment to meet critical production timelines
Quality Assurance Inspector
Product Identification Inc
06.2017 - 06.2019
- Read blueprints specifications
- Monitor operations to ensure that they meet production standards
- Recommend adjustments to the assembly/ production process
- Inspect, test, use calipers to measure materials, parts, or products for defects and any deviations from specifications, perform FAI (First Article Inspection) reports on Matrix, make labels and packaging, approve color samples and filing etc
- Responsible for ensuring the smooth running of the quality department, while ensuring that departmental targets and delivery schedules are met
- Closely monitoring and examining each stage of the production process
- In charge of archiving all quality related documents and filing
- Ensuring that the working area is hazard free and kept clean at all times
Production Operator (Clean Room)
Polyzen Medical Inc
05.2011 - 11.2014
- Calibrate or adjust equipment to ensure quality production, using tools such as calipers, micrometers, height gauges, protractors, or ring gauges
- First article inspection, run screen printing, visual and final inspection, packaging and work with Engineers
- Assemble, clean, measure, make surgical tools and test, and prepare all documentation on medical components and devices manufactured
- Manufacture product, including safely cleaning, setting-up and operating a broad range of complex process and testing equipment
- Owning in-line quality control, product inspection, testing and packing
- Perform data collection & entry
- Promote continuous learning for self and others
- Following standard operating procedures (SOPs) and work instructions
- Effectively partnering with manufacturing and technical associates to meet business needs
- Willingness to work overtime and be flexible with hours to help cover other shifts
- Following safe work practices, confronting unsafe practices
- Proactively seeking ways to continually improve our processes and products
- Experience working in a manufacturing environment utilizing a variety of production and testing equipment
- Demonstrated mechanical aptitude
- Experience working within a defined Quality System and making good product quality decisions
Assembler (Clean Room)
Aretsyn Solutions
08.2000 - 02.2011
- Pre-inspect circuit boards and packages before they enter the clean room
- Performed/ assembled tiny electronic parts under a microscope
- Compare parts to the stock list and blueprints, using measuring instruments like calipers and gauges, also did the inventory count
- Clean and inspect equipment before and at each stage of the process
- Evaluate and test the product once it leaves the clean room and before it is shipped out
- Complete first article inspection, visual QC and inspect the products, prepare paperwork for shipping
- Inspect and work with heavy computer and printers’ wirings
- Heavy lifting and move pallets
Education
Diploma - Medical Office Assistant
Ashworth University
Associate Degree - undefined
Yuba Community College
Skills
- Attention to detail
- Strong work ethics
- Ability to read and interpret product specifications
- Ability to read and interpret engineering blueprints
- Supervision
- Monitoring
- Safety standards application
- Collaboration
- Computer skills
- MS Word
- Excel
- Power Point
- Quickbooks
- Matrix
- Ax web
References
Available on Request
Languages
Punjabi
Native or Bilingual
Hindi
Full Professional
Timeline
Senior Cleanroom Tech
Carolina Components Group
09.2021 - Current
Production Technician
3Shape
07.2019 - 08.2020
Quality Assurance Inspector
Product Identification Inc
06.2017 - 06.2019
Production Operator (Clean Room)
Polyzen Medical Inc
05.2011 - 11.2014
Assembler (Clean Room)
Aretsyn Solutions
08.2000 - 02.2011
Associate Degree - undefined
Yuba Community College
Diploma - Medical Office Assistant
Ashworth University
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