- Cambrex High Point (Charles City, IA)
- …utilities, and manufacturing equipment. The position ensures that all projects meet regulatory compliance requirements (cGMP, FDA , OSHA), are delivered on time ... customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities… more
- Stryker (Mahwah, NJ)
- …work across multiple manufacturing sites and collaborate closely with R&D, Manufacturing, Quality , Regulatory , and Supply Chain to deliver projects that meet ... MIM processes, tooling, materials, and manufacturability considerations. + Ensure compliance with FDA , ISO 13485, and internal quality system requirements. +… more
- Medtronic (Fridley, MN)
- …to ensure efficiency, quality , and cost-effectiveness. + Maintain compliance with FDA , ISO, and other applicable regulatory standards. + Develop and ... regulatory compliance, and driving continuous improvement to deliver high- quality , timely repair services. The manager will collaborate cross-functionally to… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …with regulatory expectations. + Partner with Operations, R&D, and Quality , to ensure alignment of test expectations, supporting documentation, and product ... methods, fixtures, and workflows are reliable, scalable, efficient, and compliant with regulatory standards. This role focuses on building robust, automated test and… more
- Abbott (Plano, TX)
- …and supporting CER related projects and processes. + Supports additional clinical, regulatory , quality and engineering related deliverable as assigned. + ... and communications, risk reviews and other processes such as regulatory inquiries. + Ensures quality in all...(ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents) and applicable Abbott SOPs and DOPs.… more
- Kelly Services (Petaluma, CA)
- …and manage the QA team; hire and mentor quality staff + Ensure regulatory compliance with GMP, FDA , ISO13485 and combination product requirements + Oversee ... cause analysis, CAPA programs, and continuous improvement. + Engage with R&D, manufacturing, and regulatory teams to align quality and business goals What We Are… more
- Charles River Laboratories (Northridge, CA)
- …to making a positive impact on the world by providing the highest quality cellular material and services to biotech and pharmaceutical companies and research ... directly-reporting departments, as applicable, but not limited to Clinical Laboratory, Quality Control, Clean Room, Production Planning and R&D. + Collaborates with… more
- Cambrex High Point (Charles City, IA)
- …water sampling when required. + Support continuous improvement initiatives related to quality systems, audit readiness, and regulatory compliance. All employees ... customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities… more
- Fujifilm (Holly Springs, NC)
- …will maintain quality systems that align with CGMP, GDP, and other regulatory standards, ensuring product compliance through robust quality systems. You will ... leadership, and team management experience * Experience in cGMP manufacturing operations and/or Quality role in an FDA /EMA regulated facility. * Experience and… more
- Astellas Pharma (Westborough, MA)
- …of qualification and validation procedures and practices in accordance with global regulatory bodies ( FDA , EMA, ICH, Japan guidance), Astellas policies and ... maintained in compliance with user requirements, process parameters and global regulatory guidelines. The successful candidate will foster compliance across a broad… more