- Cepheid (Miami, FL)
- …waiting.Learn about the Danaher Business System which makes everything possible.The Sr. Quality Specialist is responsible for supporting quality systems ... and risk management activities in accordance with FDA and ISO regulations. This position is also responsible to apply...shelf-life.This position is part of the Product Life Cycle Quality & Stability team. It will be in Sunnyvale,… more
- Steris Corporation (Mentor, OH)
- …and life science product and service solutions around the globe. Position Summary The Quality Specialist is responsible for assisting in administration of the ... site record retention, calibration and inspection activities. In addition, the Quality Specialist will facilitate Customer complaint investigations, assist in… more
- Twist BioScience (South San Francisco, CA)
- The Regulatory Operations Specialist is responsible for ensuring the efficient and compliant management of regulatory documentation, with a primary focus on Safety ... duties & projects as assigned. Ability to travel 5% Follow regulatory and ISO 13485 requirements.What You'll Bring to the Team Bachelor's degree in a scientific… more
- Katalyst HealthCares and Life Sciences (Minneapolis, MN)
- …training materials to effectively deploy problem-solving, process control, and quality tools. Proactively identify and implement continuous improvement activities to ... opportunities. Facilitate root cause analysis and corrective actions of supplier quality issues. I independently work with suppliers for the completion of… more
- Coghlin Companies (West Boylston, MA)
- …without compromising quality Exceptional mechanical aptitude and mathematical skills. Trains Quality Inspection Specialist II and Inspection Specialist I ... Roles & Responsibilities: The Inspection Specialist III position will have an area of...Quality Management System, good documentation practices, cGMP's and ISO 13485 requirements. Advanced knowledge of working with assembly… more
- Velcro Companies (Somersworth, NH)
- …reviews, revisions, and establishment of new procedures. Perform duties in compliance to Quality Standard ISO /TS 16949, and Environmental Standard ISO 14001. ... maintenance of all manufacturing equipment, and insure the manufacture of quality products that meets or exceeds customer expectations. Essential Job Functions:… more
- Foresight Diagnostics (Boulder, CO)
- …of relevant regulations and standards (eg, IEC 62304, ISO 14971, ISO 13485). *Work closely with R&D, Quality Assurance, Manufacturing, and Marketing ... is headquartered in Boulder, Colorado. About The Role The Regulatory Affairs Specialist supports our product teams supporting new product development and lifecycle… more
- VB Spine LLC (Allendale, NJ)
- Regulatory Labeling Specialist Location : Leesburg, VA or Allendale, NJ (Hybrid) Company : VB Spine Looking for a career where your work truly matters? At VB Spine, ... and grow in a dynamic, fast-paced environment. As a Regulatory Labeling Specialist , you'll support compliant product labeling and Instructions for Use (IFUs) across… more
- Masimo (Irvine, CA)
- …international submission; Experience with FDA/GMP requirements for medical device; Experience in Quality Systems, per ISO 13485; Experience with the UL/ETL ... Job Description Job Summary In this high profile role, the Regulatory Affairs Specialist I will be an integral part of an expanding regulatory affairs team that is… more
- Clark-Reliance (Strongsville, OH)
- …Comply with policies, procedures, standards and rules of the Company. Maintain quality assurance policy consistent with ISO standards. Maintain work area ... Projects/Contract Specialist Who We Are Clark-Reliance(R) is a world...continue to grow every year. What is a Projects/Contract Specialist ? The Projects/Contract Specialist will prepare, manage… more
- VTI Life Sciences (San Diego, CA)
- …Life Sciences industry. We are looking for a Computer System Validation (CSV) Specialist to be responsible for ensuring that computerized systems used in regulated ... regulatory requirements (such as FDA 21 CFR Part 11 and 820, Data Integrity, ISO 13485 and GAMP 5.), and company policies. The role includes the development and… more
- Bosch Group (Lincolnton, NC)
- …Description We Are Bosch. At Bosch, we shape the future by inventing high- quality technologies and services that spark enthusiasm and enrich people's lives. Our ... risk/hazard analysis to meet regulatory requirements and HSE management systems ( ISO 14001 and ISO 45001). Review of environmental incidents for root cause and… more
- Howmet Aerospace (Torrance, CA)
- …(HFS) is seeking a highly skilled and experienced Statistical Process Control (SPC) Specialist at our Torrance, CA location to lead the design, implementation, and ... continuous improvement of SPC systems across our manufacturing and quality operations. This position plays a critical role in driving data-driven decision-making,… more
- Bristol-Myers Squibb Company (Devens, MA)
- …our Cell Therapy team. BMS Cell Therapy Manufacturing seeks a Specialist , Lead Manufacturing Associate Cell Therapy that brings enthusiasm, intellectual curiosity, ... must be goal-oriented, flexible, and able to work efficiently with safety and quality in mind. We are searching for enthusiastic, and innovative individuals with a… more
- Atrium Medical (Hudson, NH)
- …changes through RA/QA practices by documentating the changes in compliance with Quality Systems Regulations (QSR), the Medical Device Directives, CMDR, and other ... Administration (FDA) and the European Notified Body. Responsible for FDA/ ISO /MDD/CMDR compliance documentation. Assists in special projects as needed. Contributes… more
- Stantec (Annapolis, MD)
- Grounded in safety, quality , and ethics, our experts lead their fields with dedication, a creative spirit, and a vision for growth. We draw from more than 20 ... around the world. Stantec is seeking a part-time/flexible Environmental Compliance Specialist in any US office. Your Key Responsibilities Provide environmental… more
- Veritiv Corporation (Grapevine, TX)
- Job Purpose: Our Quality Control Specialist will be responsible for having direct oversight of ISO 9001:2015 and FSSC 22000 certifications and other ... (KPI) ensuring adherence under the management review requirements of the ISO registered quality system. *Act as company representative at all production sites… more
- Spherion (Holliston, MA)
- …with Production, Engineering, Sales, and Administrative teams. Ensure compliance with ERP-based Quality Management Systems; must be familiar with ISO 9001 ... with Production, Engineering, Sales, and Administrative teams.Ensure compliance with ERP-based Quality Management Systems; must be familiar with ISO 9001… more
- Hims and Hers Health, Inc. (New Albany, OH)
- …initiatives across the organization. You Will: Supervise and provide guidance to the Quality Control Specialist and Quality Assurance Specialist , ... see below and visit www.hims.com/careers-professionals. About the Role: The Quality Manager is responsible for overseeing the Quality...CFR Parts 210/211, 503b guidance, USP <797>, <800>, and ISO 14644. Oversee the review and approval of batch… more
- IMI Climate Control (Dallas, TX)
- …analysis and implement corrective/preventive actions (CAPA) Maintain and enhance compliance with ISO 9001 and other applicable quality standards Conduct internal ... IMI plc We are a global specialist engineering company that creates breakthrough solutions. We...as FMEA, 8D, and Root Cause Analysis Familiarity with ISO 9001, SPC, and statistical quality methods… more
