Device QC Technician I job in Exton, PA
Vacancy has expired
Exton, PA CorTech LLC
| Job Ref: | 347001 |
| Employer: |
CorTech LLC |
| Job Type: | Contract |
| Salary and Benefits: | 17.24/Per Hour |
| Remote: | No |
Location |
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| City: | Exton, PA |
| Post Code: | 19341 |
| Map: |
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Description |
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CorTech is seeking to hire a Device QC Technician I for our client in Exton, PA! Benefits Available! Weekly Pay! $17.24/Hour Shift Details: 2nd Shift M-F 2PM-10:30PM Purpose of the job: Assure Client products meet consistent & high quality by: assisting in the operation and development of QC functions for Client. Maintain accurate and timely inspection of current products while following all customer requirements and established in Client procedures. Ensure all Client products are of a high quality by: Process control testing, WIP inspections and tests and conducting standard quality testing on equipment and products. Maintain and organize data in a manner that is compliant with GLPs and GMPs within a Cleanroom setting. Job Context: Client Biomedical is the world?s unrivaled biomaterials expert and committed partner in driving sustainable innovation in healthcare. For more than 30 years, the company has been at the forefront of biomaterial science and process innovation, and the leading resource for global medical device and pharmaceutical companies. As a strategic partner with an approach driven not only by market dynamics but by the unique needs of every customer, Client Biomedical brings an unparalleled breadth of product portfolios, proprietary manufacturing and processing capabilities, world-class IP, and extensive regulatory experience and expertise. Furthermore, Client Biomedical?s products and services are recognized for their unmatched quality, consistency, and performance in multiple markets across the globe, supporting their company-wide vision of solving the world?s healthcare needs through sustainable science. To learn more, Job Content: Key Areas of Accountability / Responsibility Within a Manufacturing Cleanroom setting the Device QC Technician I assists other Technicians in daily tasks to insure proper inspection techniques and Client QC procedures are followed. Follow all Client QC procedures when inspecting in-coming materials, in-process components, and finished product. While recording all results in the proper QC required documentation. Interface with engineers, productions team members and area management as needed to provide a continuous working environment. Review documents for completeness and accuracy. Maintain label control. Perform any and all necessary in-process testing including but limited to Peel Testing, Label Inspections, Component Testing, Etc. Complete and maintain all required documentation in association with testing or inspecting of Client products. Adhere to Client Biomedical Quality System procedures regarding ISO 9001and/or 13485 standards. Provide support to other areas of the QC Department. Gives input to OOS investigations (NCR) with oversite from the Sr. QC Technicians, Technical Lead, Engineer and/or Lab Supervisor. Respond with flexibility to changes in production or personnel. Act in accordance with GMPs and provide feedback to management regarding areas of non-compliance. May be required to stand for a portion of the day lifting to 50 lbs, and manual torque inspections not to exceed 40 lbs. of force. Authorities: Provide input on new product/process launch initiatives. Provide feedback to employees and/or manufacturing management team on GMP compliance. Give suggestions on potential improvement opportunities for process documentation and quality assurance. Acts as Quality Authority within manufacturing areas. SHE & Security It is the responsibility of each employee to work in a safe and responsible manner in order to create an injury-free and incident-free workplace. Complies with all job-related safety, security and other training requirements. Report any SHE and Security incidents (including observed risks) to management Comply with Client Life Saving Rules. Project Management or Special Assignments: Internally Client Biomedical Assist process engineering and manufacturing of new products by providing inspection data for these R& D projects to gage Client capability of process to manufacture parts desired by a customer. Support process improvement in accordance with Client Biomedical Continuous Improvement Program. Aid in the development and validation of new Device Inspection methods, and qualification and maintenance of new test equipment. Complexity of the job Complexity of Tasks: Basic to moderate Independent Judgment: Moderate latitude for independent judgment Extent of Supervision: Works under moderate to minimal supervision As a key participant in the actual manufacture of Client medical devices, the QC Device Technician - Cleanroom plays an important role in identifying non-conforming materials or parts while still within the manufacturing area, and provides real-time necessary feedback to department colleagues and manufacturing managers. Day-to-day tasks may include performing and/or assigning inspections in designated areas, appropriately documenting findings and providing timely feedback to Quality, Engineering and/or Production personnel. Because the end use of the product affects patient safety, there is a need to be knowledgeable in the quality system requirements to being reasonably well-versed in technical aspects of the process. Good judgment and decision making is imperative. Knowledge and educational level: High school graduate or equivalent /education degree (GED).. Some college preferred. Basis knowledge of drawings, work instructions and part specifications. Ability to work with inspection or test equipment Ability to work in Cleanroom Environment. Required level of experiences: Minimum 0 -2-year experience. Must pay strong attention to detail and have ability to effectively communicate with various parties both internally and externally. Must have good written and oral communications skills, computer literacy, and a good standard knowledge of units of measure. | |
ref: (347001)
985 days ago
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