- Takeda Pharmaceuticals (Lexington, MA)
- …compliance with applicable medical device and software regulations (eg, FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDR/IVDR, MDSAP). + Act as or designate the ... and guidances governing medical device, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDR/IVDR, MDSAP, and global quality systems. + Strong background in… 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
- BAE Systems (Patuxent River, MD)
- …in electrical and mechanical inspections? Have you conducted or participated in ISO 9001-style internal audits? Then you just could be the Quality professional ... person selected for this role will verify compliance with ISO 9001:2015 and AS9100D Quality Management Systems and Corporate...and I&S Sector audit schedule to confirm compliance with ISO 9001:2015 or AS 9100 requirements. Make recommendations to,… more
- ITW (Eden Prairie, MN)
- …of quality metrics, product compliance management and ensuring compliance with ISO 9001 standards, including leading internal and external audits **Major Areas ... to identify systemic issues and prioritize improvement opportunities. 6. ISO 9001 Knowledge & Audit Leadership + Maintain a...& Audit Leadership + Maintain a deep understanding of ISO 9001 requirements and ensure company compliance. + Lead… more
- System One (Corvallis, OR)
- …Quality Assurance Specialist to support our client, in developing and implementing their ISO 19443:2018 Quality Assurance Program. This position is part of a staff ... the commercial nuclear sector. Responsibilities: + Develop, evaluate, and maintain ISO 19443:2018 quality assurance program processes. + Write and update procedures,… 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
- Actalent (Colonie, NY)
- …Oversight: Oversee and participate in the preparation of sterile injectable medications in an ISO Class 5 cleanroom hood within an ISO Class 7 environment, ... oversee staff performance to ensure all activities in the cleanroom maintain ISO 5/7 standards and prevent contaminationourpharma.net. Foster a culture of quality,… more
- Kelly Services (West Chester, PA)
- …in developing quality procedures, conducting audits, and ensuring adherence to ISO , NADCAP, Electric Boat, and NAVSEA specifications. Essential Duties and ... Responsibilities: Quality Systems Management- Develop, maintain, and improve ISO 9001 and NADCAP quality management systems. Create and implement quality procedures,… more
- Mitsubishi Chemical Group (Mesa, AZ)
- …requirements, troubleshoot and correct problematic areas. + Leads the efforts of AS 9100/ ISO 9001 and ISO 13485 certifications. Ensures the effectiveness and ... to North American policies and procedures. + Leads/participates on North America Internal ISO audits across the North American sites as assigned by NA Quality… more
- PCI Pharma Services (Rockford, IL)
- …equipment, process, and cleaning validation efforts to ensure compliance with FDA, ISO 13485, and other applicable regulatory standards. This role is critical in ... customer tech transfers. + Apply risk-based approaches (eg, per ISO 14971) to validation strategy and justification. + Utilize...the standards set by FDA 21 CFR Part 820, ISO 13485, and customer requirements. + Support regulatory and… more