- Astrix Technology (Irvine, CA)
- …teams ( Quality , Manufacturing, R&D, Supply Chain, Finance, etc.). + Ensure compliance with the company's Quality System policies and procedures and ... reports, etc.) + Familiarity with medical device complaint files and quality records + Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO… 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 ... as 21CFR 820.30, IEC62304:2016 amd.1, IEC81001-5-1, as well as FDA and MDCG guidance. . Responsible for the planning...and evolves approved project deliverables. . Communicates project and compliance issues to Quality Systems management and… more
- Hologic (Newark, DE)
- …Kaizen, Kanban, Poke Yoke, and visual factory ideology. + Familiarity with regulatory compliance in a FDA , Notified Body, ISO, or other regulated manufacturing ... Supervisor, Quality Assurance Newark, DE, United States We're seeking...team engagement. You'll lead a high-performing group, champion regulatory compliance , and spearhead initiatives that elevate our manufacturing processes.… more
- Boar's Head Brand/Frank Brunckhorst Co., LLC (Jarratt, VA)
- …and Hygienic Design + Subject Matter Expert, ensures interpretation, application, and compliance with external requirements USDA, FSIS, FDA , GFSI (BRC, SQF), ... the results associated with Sanitation KPI's, Internal & External Inspections (USDA, FDA , GFSI) and Customers Requirements. It is responsible for identifying food… more
- Sharing Hope SC (North Charleston, SC)
- …and enhance the Quality Management System in alignment with regulatory standards ( FDA , CMS, UNOS, AOPO, AATB). + Leads SHSC's quality strategy, ensuring ... DIRECTOR QUALITY SYSTEMS Job Details Job Location Charleston -...compliance requirements. + Champions a culture of continuous quality improvement and operational excellen ce. + Maintains knowledge… more
- Tecomet (Manchester, NH)
- **POSITION SUMMARY:** The Quality Assurance & Regulatory Affairs Manager oversees the quality management system (QMS) and ensures compliance with 21 CFR | ... and regulatory requirements. The role is critical in maintaining Tecomet's quality reputation, ensuring regulatory compliance , driving process improvements,… more
- Sysco (Dallas, TX)
- … quality management (TQM) principles, standard procedure call (SPC), HACCP concepts, CFIA/ FDA regulations would be beneficial. + Formal quality and sensory ... This role supervises the implementation of food safety and quality assurance (FSQA) support/evaluation programs and inspection/audit procedures (including… more
- Boar's Head Brand/Frank Brunckhorst Co., LLC (Brooklyn, NY)
- …Co., LLC Overview:Support the BH Audit Team with performing Food Safety & Product Quality audits at different venues to include but not limited to Food Service ... activities related to ensuring customers and suppliers are adhering to finished product quality standards and meet the expectations of the Boars Head Brand. Complete… more
- Biomat USA, Inc. (Moreno Valley, CA)
- …understand and assess FDA regulations. Strong integrity and commitment to quality and compliance . Full command of mathematics. Legible handwriting. High ... actions. **Primary Responsibilities for Role:** + Independent level of quality inspection and control - ensures center compliance... quality inspection and control - ensures center compliance with quality standards and regulations. +… more
- Integra LifeSciences (Braintree, MA)
- …are challenging what's possible and making headway to help improve outcomes. The Quality Design and Reliability Assurance (DRA) Engineer II is responsible for the ... time (where applicable). + Support implementation of SPC programs with Manufacturing and Quality Control as a part of Process Validation and Design Transfer. +… more