- Leidos (Reston, VA)
- …! **The Leidos Health Solutions Group is seeking a Portfolio Director supporting the FDA , located in the DMV area.** This position will report to the Health ... Solutions Division Manager , Vice President. The ideal candidate will provide oversight...+ Manage Integrated Master Schedules + Oversee timeliness and quality of program deliverables + Provide operational oversight, coaching,… more
- ThermoFisher Scientific (Portage, MI)
- …Conditions** Office **Job Description** Responsible for maintenance and improvement of the Quality System in compliance with FDA Medical Device Quality ... and understanding of the Medical Device industry, in vitro diagnostics and related FDA QSR/QMS Regulations. . Experience in auditing quality systems for medical… more
- University of Colorado (Aurora, CO)
- …for in-person meetings. The IND/IDE Office was implemented to support FDA -regulated high- quality human research projects throughout their regulatory lifecycle. ... IND/IDE Office Program Manager - 34555 University Staff **Description** **University of...in-person meetings. The IND/IDE Office was implemented to support FDA -regulated high- quality human research projects throughout their… more
- Keurig Dr Pepper (Columbus, OH)
- The Regional Quality Manager for DSD is responsible for providing Corporate Quality support to our DSD region for Cold Beverage Manufacturing locations - ... safe food/beverage products as defined by FSMA, six sigma Quality performance and compliance to all FDA ,...sigma Quality performance and compliance to all FDA , EPA and OSHA regulations and GFSI requirements. Expect… more
- Abbott (Des Plaines, IL)
- …education and work experience + Minimum **5 years Related to supplied product quality within an FDA /ISO certified environment.** + Multi-tasks, prioritizes and ... **Des Plaines, IL** location (in office daily) in the Abbott Molecular Diagnostics, Quality Assurance Group. The person hired in this role will Manage the Supplier… more
- Arkema (Memphis, TN)
- …(https://www.instagram.com/Arkemagroup/) Job Segment: Compliance, Pharmaceutical, Chemical Research, Quality Manager , Pharmaceutical Sales, Legal, Science, ... Quality & Compliance Manager Job Location:... Quality & Compliance Manager Job Location: Memphis, TN, United States Employment... ensures that the plant maintains compliance with all FDA (drug and food), ISO, and AIMS (Arkema Integrated… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …from ship hold, HHA, FCA, regulatory affairs, compliant handling, and product quality teams. The position will present and communicate Emerging Issus to executive ... and author responses to requests for additional information from FDA and other regulators on post market topics. The...product issue notifications. + Works together with the Customer Quality organization to identify, access, and analyze data that… more
- University of Miami (Miami, FL)
- …at the University of Miami Miller School of Medicine is actively seeking a dedicated Quality Assurance Manager to oversee the quality control and assurance ... in compliance with relevant regulatory standards and that the quality management system of the CRCMP complies with all...programs. + Conducts the preparation of research teams for FDA or other regulatory agency audits. + Assists research… more
- LSI Solutions (Victor, NY)
- …devices. After all, our customer is ultimately the patient. POSITION TITLE: Quality Assurance Manager LOCATION: Onsite at LSI Solutions in Victor, ... NY SALARY RANGE: $110,000 - $136,400 JOB SUMMARY: The Quality Assurance Manager is responsible for ensuring...is organized; how its components map to ISO 13485, FDA QMSR, EU MDR, and MDSAP requirements; how the… more
- Novo Nordisk (Princeton, NJ)
- …projects and roles. Essential Functions + Compile and submit responses to FDA communications. MANAGER , THERAPEUTIC AREA: Compile, submit and maintain ... interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to...find better and more innovative ways to improve their quality of life. We're changing lives for a living.… more
- Barilla (Ames, IA)
- …to ensure that quality standards and process procedures are met. The manager will oversee laboratory analyses to ensure that quality standards are met, ... Facility contact person for audit/inspection in the area of quality and food safety (eg FDA , FSSC...Organic, customers, etc). + Define budget and capex for Quality & Technology in agreement with plant manager… more
- Nestle (Burlington, WI)
- …_This position is not eligible for Visa Sponsorship._ **POSITION SUMMARY:** The Senior Quality Manager is responsible for administration of quality programs ... quality systems to assure compliance with Nestle and FDA regulatory requirements. **PRIMARY RESPONSIBILITIES:** * Part of the...or related field **EXPERIENCE:** + 5+ years in a quality management/leadership role, previous quality manager… more
- Katmai (Brilliant, OH)
- Position is responsible for the implementation, monitoring and maintenance of the Quality System in accordance with FDA Medical Device and Drug regulations. ... FDA requirements. + Conduct and participate directly in quality inspections, internal and external audits, and FDA... quality inspections, internal and external audits, and FDA inspections. + Participate in CAPA systems. Prepare reports… more
- Catalent Pharma Solutions (Harmans, MD)
- ** Manager , Quality Systems Audit** **Position Summary** Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry ... therapeutic products including AAV and other viral vector-based therapies and vaccines. The Manager , Quality Systems Audit is responsible for the management and… more
- Reynolds American (Clarksville, TN)
- Quality Performance & Compliance Sr Manager Reynolds American is evolving at a pace like no other organization. **To achieve the ambition we have set for ... Come be the change!** **WE ARE LOOKING FOR A QUALITY COMPLIANCE & PERFORMANCE SR MANAGER ** SENIORITY...Quality , Manufacturing, Maintenance, Site GM **External** - Suppliers, FDA **Geographic Scope** LOCAL **Travel Required** 10% **WHAT YOU… more
- US Foods (Aurora, IL)
- …food safety and quality continuity. + Ensure regulatory compliance with USDA, FDA , State and local authorities and act as division's primary liaison with these ... presentation to casual family dining, our procurement experts will find the best- quality options that work for your budget and pack-size needs, carefully selected… more
- TestPros (Silver Spring, MD)
- …or a related field. + Certification in quality management (eg, ASQ Certified Quality Manager , Six Sigma). + Experience with electronic quality management ... Trust Clearance Job Summary: We are seeking an experienced Quality Assurance (QA) Manager to lead our...field. + Minimum of 5 years of experience in quality assurance, with a focus on FDA -regulated… more
- Olympus Corporation of the Americas (Westborough, MA)
- …response process and activities. + Monitors for timely completion of applicable Customer Quality commitments to US FDA , and other Regulatory Authorities as ... audits. The position will be responsible for reviewing and authoring all Customer Quality external audit responses prior to submission to corporate compliance and /… more
- Integra LifeSciences (Plainsboro, NJ)
- …challenging what's possible and making headway to help improve outcomes. The ** Manager , Quality Systems** is responsible for assigned GMP compliance activities. ... This includes managing the Quality Systems group, which manages key areas of the...Maintain thorough understanding of the following guidelines and regulations: FDA GMPs, ISO9001, ISO 14971, ISO 13485 standards, Integra… more
- Amneal Pharmaceuticals (Bridgewater, NJ)
- …Drug Device Combination Product Manager is a position within the Global Quality Management department.This position is a Corporate Quality function and is a ... Amneal's compliance standing, customers or reputation. This role provides corporate quality support and leadership with developing and implementing quality … more