- Teleflex (Mansfield, MA)
- …experience of working in the medical device industry preferred * Experience with cGMP, FDA regulations, and ISO Quality Systems , strongly desired * Experience in ... and corrective actions in support of the Teleflex Medical Quality System and manufacturing processes. Adhere safety, manufacturing and Quality procedures and… more
- Integra LifeSciences (Boston, MA)
- …quality control Analytical laboratory testing of in-process, finished goods, validation studies, and adherence to all applicable regulations, policies, and ... as needed. + Assist as needed in test method validation , investigation studies or other product development studies. +...(CAPAs). + Assist in preparing for and participating in FDA audits, customer audits, etc. + All other duties… more
- Fresenius Medical Center (Lawrence, MA)
- …Understanding of Agile methodology desired but not required. . Thorough understanding of FDA Quality System regulations in relation to software development and ... and/or guide software project teams to ensure that software systems are compliant with procedures and Regulations such as...as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning… more
- Medtronic (Boston, MA)
- …, complete requirements definition, design, code implementation, unit test, and software and system verification and validation . + You will also participate in ... Robotic Assisted Surgery platform within the Surgical Operating unit: https://www.medtronic.com/covidien/en-us/robotic-assisted-surgery/hugo-ras- system .html Medtronic's Surgical Operating Unit is one new, powerful… more
- Integra LifeSciences (Braintree, MA)
- …procedures. + Support the implementation of new or improved quality control systems as needed. + Ensure compliance with industry regulations, company policies, and ... archived materials and solutions. + Assist as needed in test method validation , implementation, and execution. + Provides database support, generate reports and… more
- Teleflex (Chelmsford, MA)
- …Skills / Other Requirements** * Knowledgeable of ISO 13485, ISO 14971, and FDA QSR requirements. * Computer skills, including proficiency with Microsoft Word, ... and drive improvement in 5 main areas of the Quality Management System including CAPA & Nonconformance (NC) Processes; Incoming Inspection Improvements; Perpetual… more
- Bristol Myers Squibb (Devens, MA)
- …their work. + Completes documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Solves ... Performs tasks in a manner consistent with the safety policies, quality systems , and GMP requirements. Completing training assignments to ensure the necessary… more
- Bristol Myers Squibb (Devens, MA)
- …their work + Completing documentation required by process transfer protocols, validation protocols, standard operating procedures, and batch records. + Performing ... tasks in a manner consistent with the safety policies, quality systems , and GMP requirements. + Completing training assignments to ensure the necessary technical… more
- Medtronic (Billerica, MA)
- …pharmaceutical, or other regulated industries. + Knowledge of **ISO, ASTM, and FDA regulations** related to packaging validation and compliance. + Familiarity ... to be independently mobile. The employee is also required to interact with a computer , and communicate with peers and co-workers. Contact your manager or local HR to… more
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