The Maintenance Engineer works on installing, repairing, and maintaining machinery, and equipment, and keeps tools and equipment working smoothly for company production activities. This position reports to the Manufacturing Engineering Manager. Duties and responsibilities. Maintenance and repair of plant operational systems including facility, HVAC, electrical, air and piping, production and packaging equipment at company different locations. Lea...
. The QA Document Specialist will be responsible for maintaining proper documentation practices to ensure compliance to FDA, ISO, and other regulatory requirements as applicable, including drafting new documents and review of records. Duties and responsibilities. Work with a cross-functional team to ensure all documents are properly stored and archived. Facilitate the periodic review of documents to comply with internal QMS requirements. Ensure c...
The QC Laboratory Technician's main responsibility is to conduct testing to ensure the raw materials, in-process products, finished products, and other materials meet the requirements set forth to ensure the quality of the products by Healgen’s QMS, which follows FDA 21 CFR 820, GMP, and ISO 13485. The QC Laboratory Technician should know different testing standards and be comfortable using laboratory equipment and other tools. Duties and Respons...
. We are seeking a highly motivated and detail-oriented Clinical Affairs Associate to join our dynamic team. The successful candidate will play a crucial role in supporting clinical affairs activities, ensuring compliance with regulatory requirements, and contributing to the overall success of our clinical studies. You will have an opportunity to play a significant part in making the latest diagnostic tests and devices available quickly and safel...
. . . The Sales Representative is responsible for direct sales within described geographical territory. They are the principal point of contact between a business and its customers. Sales reps ensure current customers have the right products and services, identify new markets and customer leads, and pitch prospective customers. . Duties and responsibilities. Implement product sales strategies to ensure sales goals and targets are achieved. Work w...
The Customer Service Representative answers incoming customer phone calls, processes customer orders, manages customer relationships and collaborates with Quality Assurance to ensure customer satisfaction. Duties and Responsibilities. Process sales orders timely and accurately from customers via email and fax. Professionally answer telephone, log and screen and direct calls, gathering and communicating correct data for customer. Proper use of int...
Join us on our exciting journey. Healgen Scientific is a global leader in developing, manufacturing and commercializing In-Vitro Diagnostic test systems. Since our inception in 2007, we have strived to develop devices that meet and exceed industry standards. Our comprehensive portfolio of high quality, tailored solutions span multiple testing categories and analytes to meet various clinical and laboratory needs. Our products include rapid visual ...
The Automation Operator is responsible for various day-to-day functions, from set-up and loading to operating machinery with efficiency. They are responsible for monitoring, maintaining, and operating production equipment and are also responsible for cleaning and quality-checking their machinery to ensure everything works as it should. Duties and Responsibilities. Operate and maintain automated production lines for medical devices. Work in a safe...
. Healgen Scientific is a global leader in developing, manufacturing and commercializing In-Vitro Diagnostic test systems. Since our inception in 2007, we have strived to develop devices that meet and exceed industry standards. Our comprehensive portfolio of high-quality, tailored solutions span multiple testing categories and analytes to meet various clinical and laboratory needs. Our products include rapid visual tests, digital point of care (P...
The Quality Assurance Associate will assist with establishing, implementing, and maintaining an effective quality system. Ensure that purchased and manufactured material consistently meets design, QA, and manufacturing requirements and meets regulatory compliance with the FDA, ISO, and the IVD Directive. Responsible for handling quality events such as customer complaints, CAPAs, SCARs, and nonconformance, along with maintaining proper documentati...
A Maintenance Technician is in charge of performing ongoing facility maintenance and completing repairs on equipment. Their duties include fixing machinery, plumbing, heating, and wiring, inspecting buildings to confirm safety standards, and scheduling major repairs with the building’s inhabitants. Duties and responsibilities. Inspect buildings, equipment, and systems to identify any issues. Assist with building and equipment repairs if possible....
