- Integra LifeSciences (Princeton, NJ)
- …and records with all company policies and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, ISO 14644, ISO 14698, BS ... EN 17141, EU GMP Annex 1, ISO 11135, ISO 11764, ANSI/AAMI ST98, ISO 11137, ISO 11737-1/2/3, ISO 11765, ISO 11138, ANSI/AAMI ST 72and USP. +… more
- Integra LifeSciences (Plainsboro, NJ)
- …as per outlined production schedules. All production is to be conducted in compliance with ISO 7 and ISO 5 Clean Rooms and with Good Manufacturing Practices ... met, working within FDA medical device regulations, and applicable ISO standards. + Responsible for the overall direction, coordination,...timely manner. + Pass and maintain gowning qualification for ISO 5 and ISO 7 Clean rooms.… more
- Integra LifeSciences (Plainsboro, NJ)
- …cleaning of all clean room manufacturing equipment. All chemical processing operations are performed in ISO Class 5 or ISO Class 7 areas and require proper Clean ... and maintain gowning qualification to perform Gowning Requirement for ISO Class 5 Clean room operations or ISO... ISO Class 5 Clean room operations or ISO Class 7 Clean room operations. + Responsible for… more
- Teradyne (North Reading, MA)
- …knowledge of industrial automation, robotics systems, and functional safety standards such as ISO 13849, IEC 61508, and IEC 60204, along with hands-on experience in ... + Interpret and apply relevant global standards, such as: + ISO 12100 (Safety of Machinery) + ISO 10218 / ISO 15066 (Robotics and Collaborative Robots)… more
- Twist BioScience (South San Francisco, CA)
- …and/or organize products for shipping.Work according to Good Manufacturing and ISO practices. Learn, adopt and promote lean manufacturing concepts.Complete all the ... daily assigned tasks to keep the manufacturing schedule on track and report back to Lead and Supervisor.What You'll Bring to the TeamRelevant experience that can indicate success in a high throughput, fast paced laboratory manufacturing environment.Associates… more
- Aptyx (Charlotte, NC)
- …related to fluoropolymers. Experience in medical device development within an ISO 13485 environment. Ability to design experiments, analyze data, and propose ... clear next steps. Strong written and verbal communication skills. Preferred Qualifications Experience with vascular, implantable, or catheter based devices. Prior exposure to supplier qualification and raw material specification development. Familiarity with… more
- Aptyx (Charlotte, NC)
- …is highly preferred to plan and conduct complex development projects within FDA and ISO regulatory requirements. Education BS or MS in Engineering is required PMP or ... other certificated preferred Experience 3+ years experience in engineering for medical devices Experience with concept to commercialization is preferred Skills, Knowledge, and Abilities Strong analytical and problem-solving skills Excellent verbal and written… more
- Repligen (Clifton Park, NY)
- …precision measurement tools like calipers and pin gauges.Operate in an ISO 7 cleanroom while following strict gowning procedures.Support additional quality-related ... functions as needed.QualificationsWhat You Bring:High School Diploma or equivalent (required); Bachelor's degree in science or relevant experience preferred.Experience in Quality Assurance (QA) or Quality Control (QC) is a plus.Strong attention to detail and… more
- Merck & Co. (Rahway, NJ)
- …control measures, and performing overall device risk evaluations in compliance with ISO 14971 and other relevant standards. Ensure alignment with corporate policies ... and communicate effectively with cross-functional stakeholders and external suppliers.Support Design Transfer activities to internal and external sites ensuring proper translation and implementation of risk control measures.Analyze information from post-market… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …biochemical and microbiological concepts is required.Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is preferred.Ability to quickly ... process complex information and often make critical decisions with limited information.Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities.Proficient in applying process excellence tools… more
