- Synectics Inc (Dublin, CA)
- …between facilities. Cross-functional Collaboration: Work closely with cross-functional teams, including R&D, Quality Assurance , Regulatory Affairs , and ... Compliance: Ensure all transferred processes comply with relevant industry standards, regulatory requirements, and quality assurance protocols. Equipment… more
- BEL (Little Chute, WI)
- …to support departmental objectives. Work in conjunction with the Analyst, Quality Assurance and Regulatory Affairs and/or Manager, Quality and ... data entry into Quartz module. Provide back-up to Analyst, Quality Assurance and Regulatory Affairs and Sr. Manager, Quality and Regulatory… more
- Pall (Miami, FL)
- …fields with 15 years of progressive Regulatory compliance and / or quality assurance experience.Thorough understanding of ISO 9001 and AS9100 / CAA Part ... the Danaher Business System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international regulations… more
- Katalyst HealthCares and Life Sciences (Philadelphia, PA)
- …internal and external stakeholders, including Biostatistics, Clinical Development, Quality Assurance , and Regulatory Affairs , to facilitate seamless data ... data management activities, ensuring accuracy, consistency, and compliance with regulatory standards. Oversee database build activities, data collection, coding,… more
- Foresight Diagnostics (Boulder, CO)
- …62304, ISO 14971, ISO 13485). *Work closely with R&D, Quality Assurance , Manufacturing, and Marketing teams to ensure regulatory requirements are integrated ... Diagnostics is headquartered in Boulder, Colorado. About The Role The Regulatory Affairs Specialist supports our product teams supporting new product development… more
- Abbott (Santa Clara, CA)
- …experience in regulatory preferred but may consider quality assurance , research and development/support, scientific affairs , operations, or related area. ... catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite opportunity working out… more
- Global Technical Talent (Newark, DE)
- …- Work effectively with other functions such as research and development, Procurement, Design Quality Assurance , Regulatory Affairs , and Field Service in ... communication of relevant information. - Interface with suppliers and Quality Engineering to resolve supplier quality issues....suppliers and Quality Engineering to resolve supplier quality issues. - Monitor quality reports and… more
- AbbVie (North Chicago, IL)
- …for future success. Develop, support and execute a holistic quality assurance model for regulated Medical Affairs and RWE generating activities, inclusive ... of drug/device development programs. Associate Director, Safety, Medical & Regulatory Quality is part of the R&D...of Medical Affairs , RWE generation, epidemiology, and/or quality assurance supporting those areas. 5 years… more
- Cencora (Albany, NY)
- …pharmaceutical manufacturing environment. This role collaborates with production, quality assurance , and regulatory affairs to maintain contamination ... and execution of onsite cleaning validation programs compliant with the regulatory requirements. Prepare and review completed and executed validation packages by… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. JOB SUMMARY The Senior Director, Head Medical affairs Quality Assurance in Global RD/PV QA is accountable to ... stakeholders. The role will manage and or support medical affairs Quality resources (US, Brazil, Japan/ APAC...and compliance Marketing/ commercial GMP QA/ Supply chain / Regulatory Affairs Leadership/ team management: Create a… more
- Vanderbilt Health (Nashville, TN)
- …meetings to develop resolution to problems. Identify, establish and evaluate quality assurance standards, programs, and procedures within department. Establish ... through preeminent programs in patient care, education, and research. Organization: Quality Admin Job Summary: The Associate Director supervises, coordinates and… more
- Applied Medical (Rancho Santa Margarita, CA)
- …: Collaborate effectively with cross-functional teams, including production, engineering, and regulatory affairs , to resolve quality -related issues and ... such as pin gauges, caliper, micrometer, ruler, optical comparator, and Keyence. Quality Assurance : Understand and comply with Applied Medical's Quality… more
- Cardiosense (Chicago, IL)
- …selection, investigator training, study execution, patient recruitment, data collection, and quality assurance . -Ensure adherence to study timelines, budgets, ... design and execution processes. Regulatory & Compliance Oversight: -Partner with regulatory affairs teams to ensure clinical studies are compliant with FDA,… more
- Veterans Health Administration (Somersworth, NH)
- …for this position: SPECIMEN COLLECTION COMPUTER SKILLS CUSTOMER SERVICE PATIENT CARE QUALITY ASSURANCE You will be rated on the following Competencies ... for this position: Computer Skills Customer Service (Clerical/Technical) Patient Care Quality Assurance Specimen Collection IMPORTANT: A full year of… more
- Ro (Romeoville, IL)
- …collaborate with cross-functional teams, including R&D scientists, production staff, and quality assurance professionals, to develop and scale new formulations. ... guidelines in all compounding activities, maintaining the highest standards of safety and quality Collaborate closely with Quality Assurance to validate… more
- Veterans Health Administration (San Diego, CA)
- …indicators. Interacts with management officials and vendors providing inter-laboratory quality assurance and laboratory proficiency testing. Develops validation ... and relationships to the organization. f. Comprehensive knowledge of laboratory quality control/ assurance policies, procedures and principles, as well as… more
- Ascendis Pharma (Palo Alto, CA)
- …and PV Compliance team will provide appropriate representation during PV related regulatory inspections or internal quality assurance /corporate compliance ... the oversight of the PV Vendor processing ICSRs for Ascendis Products. Performs Quality Checks of processed ICSRs and provides feedback to PV Vendor as applicable.… more
- HonorVet Technologies (San Jose, CA)
- …will work closely with cross-functional teams, including Engineers, Scientists, Regulatory Affairs and Quality Assurance , to ensure accurate and timely ... SOP) Reviews and audits other technical publications deliverables and consistently delivers quality documentation. As regulations change and quality systems are… more
- Vertex Pharmaceuticals (Boston, MA)
- …teams, including Analytical Development, AS&T, CMC, Supply Management, Regulatory Affairs , Program Management and Quality Assurance , as well ... Job Description General Summary: The Manager of Quality Control will be responsible for supporting the...and internal procedures. Work with CMC technical SMEs and Regulatory to prepare and review QC related sections of… more
- Veterans Health Administration (Los Angeles, CA)
- …testing. Maintains process control in a specialty area through a multifaceted quality assurance program. Performs other related duties as assigned. Work ... adopts appropriate methods and testing. Applies laws, policies, precedents, regulatory , licensing, and accrediting requirements to establish, monitor, and maintain… more
