- BioAgilytix (Durham, NC)
- …in the update, enhancement, and creation of internal policies and proceduresSupports regulatory compliance to ISO, FDA, and other worldwide regulatory ... timelines as well as the preparation of submissions.Essential ResponsibilitiesProvides guidance to product core teams to ensure that all regulatory submissions… more
- Catalent (St. Petersburg, FL)
- Manager, QA ( Product Development)Position SummaryThe Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support ... the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, Change Control, Client interface, Lab Investigations, Deviations,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …mindset and culture through partnering with stakeholders to streamline the product lifecycle process and develop risk mitigation strategies. Provide quality ... risk-based assessment for Distributors, co-partners, and affiliates. Liaise with Audit and Compliance team to ensure that GVP audits are planned, communicated and… more
- Tris Pharma (Monmouth Junction, NJ)
- …and Preventative Actions (CAPAs) and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality ... Tris has an immediate opening for a Manager, Quality Management Systems ( QMS ). Summary:The Manager, Quality Management Systems ( QMS ) supports, oversees and… more
- Veolia North America (Boulder, CO)
- … product line business has an opportunity for a QMS & Product Regulatory Compliance Specialist in Boulder, Colorado. **Job Description** **Position ... Purpose** The Quality Management System ( QMS ) and Product Regulatory Compliance Specialist will be responsible for managing all aspects of site-wide ISO … more
- Xybion Corporation (Boston, MA)
- …business processes, we help companies become more efficient, reduce costs and manage compliance , regulatory adherence and risk. Our unique solutions focus on ... integrated preclinical lab management LIMS, QC and Diagnostics LIMS, ELN, QMS , DMS and Risk Prediction softwares. Xybion consulting offers Design Thinking, Business… more
- Valcor Engineering (Springfield, NJ)
- …They will utilize the corrective and preventive action process to correct compliance nonconformances and drive improvement of QMS supporting documentation. ... and assure compliance to governing requirements. + Create and update QMS supporting documentation such as Quality Manual, Standard Operating Procedures and Work… more
- Philips (San Diego, CA)
- …during product surveillance and QMS audits, as needed. + Support regulatory process improvement initiatives, QMS Compliance and other Regulatory ... strategies, including submission risk mitigation, through deep understanding of the product 's technical characteristics and regulatory landscape. + Achieve… more
- Abbott (Atlanta, GA)
- …outside of US (OUS) geographies. **What You'll Work On** + Acts as a regulatory representative on core product development teams, communicates regulatory ... international product registrations and licensing requirements. + Develops global regulatory strategies for new and modified products. + Prepares and submits PMA… more
- Abbott (Pleasanton, CA)
- …directly with regulatory agencies as needed. + Conducts reviews of product and manufacturing changes for compliance with applicable regulations. + ... and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry. The individual may… more
- Actalent (Bedford, MA)
- …labeling/advertising review and other regulatory work required to maintain regulatory compliance . Responsibilities: Responsible to participate on design and ... regulatory plans for both new products and significant product modifications, documentation of regulatory impact from...data or reports that could be incorporated into future regulatory submissions to assure compliance with current… more
- Abbott (Plymouth, MN)
- …applications to achieve departmental and organizational objectives. + Acts as a regulatory representative on core product development teams, communicates ... for product release. + Conducts reviews of product and manufacturing changes for compliance with...divisional management and in support of Quality Management Systems ( QMS ), Environmental Management Systems (EMS), and other regulatory… more
- Abbott (St. Paul, MN)
- …partnerships to further departmental and organizational objectives. + Reviews of product and manufacturing changes for compliance with applicable regulations ... by divisional management and in support of Quality Management Systems ( QMS ), Environmental Management Systems (EMS), and other regulatory requirements.… more
- Abbott (Austin, TX)
- …partnerships to further departmental and organizational objectives + Reviews of product and manufacturing changes for compliance with applicable regulations ... as identified by management and in support of Quality Management Systems ( QMS ), Environmental Management Systems (EMS), and other regulatory requirements +… more
- Lauridsen Group Inc. (Ankeny, IA)
- …Manager of Regulatory Affairs is responsible for leading and managing regulatory activities to ensure compliance with applicable global regulations and ... and Quality Systems:** + Maintain Quality Systems knowledge to support Regulatory Affairs and Quality Assurance for compliance and continuous improvement.… more
- Belcan (Bloomingdale, IL)
- …with relevant teams to address customer needs effectively. * Manage Compliance Regulatory Reporting (outsourced) * Assign responsibility and authority ... Quality Assurance & Compliance Manager Job Number: 349218 Category: Quality Engineering...information on interested parties. * Establish and continually improve QMS processes based on ISO 9001:2015 guidelines. * Ensure… more
- ITW (Solon, OH)
- … department, deliver on company goals, and develop the team + Maintain regulatory updates for compliance with customer, ISO 9001, and government requirements ... and assure that the documents are controlled within ERP/ QMS software + Manage regulatory finance schedule and report results to management + Work… more
- Belcan (Mentor, OH)
- …division quality objectives are achieved. Responsibilities: * Conduct internal Quality Management System ( QMS ) audits to AS9100 Rev. D for all for 4 value streams. * ... support and support materials control lab * Manages the Quality Management System ( QMS ) by maintaining and consolidating QMS procedures, coordinating QMS … more
- ADM (Kennesaw, GA)
- …SCOPE** The Quality Manager is responsible for maintaining all facility and product -level certifications. This position will host external audits for all parties, ... including regulatory agencies, certification bodies, and customers. They will create...changes to critical documents within the scope of the QMS . + Ensure that records are established and maintained… more
- Merck (Rahway, NJ)
- **Job Description** The QMS Senior Specialist is responsible for providing leadership and direction for the execution of processes and procedures in support of the ... global QMS controlled documentation and systems. This position provides hands-on...health products, with an objective to enable consistently compliant product quality, continuous improvement, and effective life-cycle management. **Primary… more
