- Twist BioScience (South San Francisco, CA)
- …services by implementing and maintaining a quality management system (QMS) that complies with ISO 13485 and ISO 14971. This position is also responsible for ... Be Doing Implement and maintain a QMS that complies with ISO 13485 and ISO 14971.Conduct risk assessments to identify and assess potential hazards associated… more
- 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
- Terumo Neuro (Aliso Viejo, CA)
- …sterilization expertise during interface with regulatory agencies, including FDA and ISO . + Support clean room monitoring and validation activities, including, but ... (4) years of related professional experience. 3. Understanding of ISO and FDA requirements for medical product sterilization and...medical product sterilization and for cleanroom monitoring. 4. EN ISO 11135, EN ISO 11137, EN … 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 ?Desired Minimum Qualifications… more
- Polaris Industries (Wyoming, MN)
- …across multiple programs. This role ensures compliance with industry standards (eg, ISO 26262, ISO /SAE 21434) and alignment with program milestones, working ... leadership and customers. - Support internal and external assessments, including ASPICE, ISO 26262, and ISO /SAE 21434 audits. **Qualifications:** Bachelor's or… more
- Integra LifeSciences (Plainsboro, NJ)
- …in compliance with company policies, US Food and Drug Administration and DOT/IATA, ISO 13485, and other applicable regulatory agencies. **This is a Weekday Shift, ... 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
- Repligen (Rancho Dominguez, CA)
- …investigations and prepare reports for customer complaints.Conducts or participates in ISO audits, internal audits, and Customer audits.Preparing and review Quality ... products and raw materials non-conformance investigations, review and disposition.Performing ISO , GDP, and technical training.Interfacing at all organizational levels… more
- Merck & Co. (Rahway, NJ)
- …working knowledge of standards relevant to device components and combination products, including ISO 11608, ISO 11040, ISO 80369, as well as ... performance tests related to container closure integrity and dose accuracy, among others.Proven track record of applying analytical skills in product test method design, development, and validation.Working knowledge of analytical test method technology… more
- GRAIL (Durham, NC)
- …in compliance with GRAIL's Quality Management System procedures and regulatory requirements including ISO 13485, ISO 14971, 21 CFR 820, IVDR, CAP/CLIA/NYSDOH, ... applicable regulations and standards, including but not limited to QSR, ISO 13485, CAP/CLIA, NYSDOH, ISO 15189, IVDR. + Experience using an eQMS required; Veeva… more
- Caris Life Sciences (Phoenix, AZ)
- …laboratory, operational, and customer-facing functions to maintain compliance with FDA, ISO 13485, CAP, and CLIA requirements while driving data-informed continuous ... global Quality System and Regulatory framework, maintaining compliance with applicable FDA, ISO 13485, CAP, and CLIA standards. The analyst contributes to continuous… more
- Enverus (Austin, TX)
- …and/or generation interconnection planning engineer or project manager to work with ISO , utility, and project developer clients to map customer pain points to ... team + Providing technical support to transmission and interconnection teams at ISO , utility, and project developer clients + Identifying, developing, and growing… more
- Integra LifeSciences (Princeton, NJ)
- …with US and International requirements as defined in FDA Regulations, ISO Standards, European Medical Device Directives, and other International Regulations. This ... in compliance with corporate policies, US Food and Drug Administration regulations, ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU Medical Device… more
- Teleflex (Wyomissing, PA)
- …activities in support of quality system requirements (eg, FDA 21 CFR Part 820, ISO 13485, ISO 17025). - Manage and execute complex projects independently, ... validation. - Demonstrated experience working within quality-regulated environments (FDA, ISO standards) in medical device, biotech, or pharmaceutical industries. -… more
- Olympus Corporation of the Americas (Westborough, MA)
- …and medical device SW regulatory standards to the Olympus SDLC, including IEC 62304, IEC 82304, ISO 14971, ISO 13485, ISO 81001-2, ISO 81001-5-1, and ... AAMI TIR34971. This includes providing leadership, technical direction and collaboration on development strategies, concepts, design evaluation and proof of concept. This individual must work with product management, business units, engineering product owners… more
- Caris Life Sciences (Phoenix, AZ)
- …laboratory, operational, and customer-facing functions to maintain compliance with FDA, ISO 13485, CAP, and CLIA standards while driving proactive identification of ... Caris' Quality System procedures and applicable external requirements (FDA 21 CFR, ISO 13485, CAP/CLIA, PMDA, CMDCAS, and other global regulatory frameworks). + Lead… more
- Integra LifeSciences (Plainsboro, NJ)
- …with company policies, US Food and Drug Administration and DOT/IATA, ISO 13485, and other applicable regulatory agencies. **SUPERVISION RECEIVED** Under direct ... + Follow applicable Standard Operating Procedures, Quality System Regulations and ISO 13485 requirements. + Responsible for reporting all discrepancies to the… more
- Powell Industries, Inc. (Houston, TX)
- …internal audit results and write final audit reports. - Coordinate Powell's ISO Certification Audits with a third party Certification Company. - Support the ... Powell's training system. - Read, interpret, and apply the ISO quality system standard. Minimum Qualifications - A minimum...Word, Excel, PowerPoint, Access, Visio. - Qualified as an ISO QA systems auditor. - Familiar with the ISO9001:2015… more
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