- Kelly Services (Orange, CA)
- …+ Required High School Diploma, Degree or equivalent. + 1-3 years in Quality Document Control FDA regulated industry. **What Happens Next:** Once you ... consideration, please apply. Kelly(R) Science & Clinical is seeking a Quality Assurance Administrator for a temporary position (potential to extend/convert) at… more
- AbbVie (Dublin, CA)
- …compliance & enhance overall quality of the product. + Work in a quality engineering FDA regulated Medical device manufacturing environment. + Serve as ... criteria, procedures, and training. + Perform duties in compliance with FDA 's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations,… more
- Mayo Clinic (Jacksonville, FL)
- …and provides the resources you need to succeed. **Responsibilities** The Quality Analyst, FDA Regulated Manufacturing is responsible for implementation ... quality and regulatory compliance for product manufacturing activities. The Quality Analyst directs the work to identify and reduce regulatory, accreditation,… more
- TreeHouse Foods, Inc. (Lancaster, PA)
- …occupational safety (OSHA), building and electrical codes, and food safety and food quality ( FDA ) in addition to environmental safety (EPA) in accordance with ... **Employee Type:** Full time **Location:** PA Lancaster **Job Type:** Quality Assurance **Job Posting Title:** Quality Assurance Technician-2 **About Us:**… more
- Stryker (Portage, MI)
- …factors engineering, risk management, and design validation, while ensuring compliance to Stryker quality system, FDA Quality System Regulations, ISO 13485 ... Stryker is hiring a **Senior New Product Development (Advanced) Quality Engineer** **(Hybrid)** in **Portage, Michigan** , to support **Instruments**… 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
- Actalent (Camarillo, CA)
- …affairs, Medical device, Regulatory, Regulatory documents, biology, gmp, biotech, quality assurance, FDA , certificates, Product labeling, licensing, reporting, ... ISO 13485, FDA certification, quality , quality systems, qms, eQMS, GMP auditing, EH&S saftey, audit Top Skills Details: labeling,regulatory comliance, FDA … more
- Edwards Lifesciences (Irvine, CA)
- …or a cath lab, eg, Registered Nurse, CST, PA, MD or Practitioner. * Direct Quality Complaints experience in FDA MDR * Experience working in a large manufacturing ... of new concepts, techniques, and standards * Extensive understanding of FDA 's Quality System Regulation * Working knowledge of Medical Device regulations, such… more
- Caris Life Sciences (Phoenix, AZ)
- …in the IVD or medical device manufacturing space. + Knowledge of ISO 13485 and ISO 14971, FDA Quality System Regulation 21 CFR Part 820 or CGMP is a plus. + ... **Position Summary** + Staff Operations Quality Engineer provides quality assurance support...regulations pertaining to, or experience working in, clinical/CLIA/CAP/LDT and/or diagnostic/ FDA /IVD labs is a plus. + Experience working within… more
- Teleflex (Mansfield, MA)
- …as a Medical Device (SaMD) and software validation. * Working knowledge of US FDA quality system regulations, ISO 13485:2016, ISO 14971, EU medical device ... Compliance Engineer, Quality Systems **Date:** Sep 12, 2024 **Location:** Mansfield,...to other departments. **Principal Responsibilities** * Clear understanding of FDA and rest of world compliance trends and application… more
- Bristol Myers Squibb (Indianapolis, IN)
- …with RSO and QA to ensure compliance with GMP regulations, safety guidelines, and quality standards ( FDA , USP, NRC, EP, and other regulatory agencies as needed). ... the global leader in radiopharmaceuticals. RayzeBio is seeking a Quality Control Supervisor, reporting to the Sr. Manager of... Control Supervisor, reporting to the Sr. Manager of Quality Control. The position will oversee quality … more
- ThermoFisher Scientific (Logan, UT)
- …deliver executive updates + Knowledge of pharmaceutical, biologics and/or medical device quality systems ( FDA , ISO13485, MDSAP, etc.) + Project management skills ... our US SUD sites. **Discover Impactful Work:** The role is part of the Quality Customer Advocacy program which is seeking to develop strong connections with Core… more
- Dentsply Sirona (Johnson City, TN)
- …company goals and objectives, policies and procedures in compliance with quality systems, FDA regulations and MDD/MDR requirements. + Develops/implements/ensures ... portfolio of world class brands. Dentsply Sirona's products provide innovative, high- quality and effective solutions to advance patient care and deliver better… more
- LSI Solutions (Victor, NY)
- …+ Excellent attention to detail and strong follow-up skills. + Knowledgeable on FDA Quality System Regulation and proficient with related submissions for device ... to Domestic Regulatory Projects will 1) prepare regulatory submissions, including FDA Q-Submissions, 513(g) Submissions, 510(k) Submissions, and De Novo Requests as… more
- ADM (Decatur, IL)
- …biochemistry or similar discipline is preferred. + Previous experience working in a quality control or FDA regulated environment is preferred. + Candidate must ... **89521BR** **Job Title:** Lead Quality Control Technician - Decatur, IL **Department/Function:** Operations: Manufacturing, Production, Maintenance, Utilities **Job… more
- J&J Family of Companies (Raynham, MA)
- …risk management + Advanced understanding of Global and Regional GxP Regulations including FDA Quality Systems and ISO 13485 **Preferred:** + Working knowledge of ... Director, Quality Management Systems - 2406201489W **Description** Johnson &...and interprets regulatory requirements such as: National Regulatory agencies ( FDA , MDA, etc.), Standards organizations (ISO, IEC, AAMI, ICH,… more
- Abbott (Sylmar, CA)
- …typical to meet the skills and responsibilities of the position. + Knowledge of FDA Quality System Requirements and other applicable US Code of Federal ... the way doctors treat people with heart arrhythmias, or irregular heartbeats. ** Quality Engineer I** is responsible for administrative and tactical activities that… more
- Stryker (Redmond, WA)
- …rationale for testing, when required, to address post-market issues + Monitor compliance to Quality Procedures and FDA Quality System Regulations (QSR's) and ... internships. This intern role is responsible for continuous product and process quality improvements. You will conduct investigations (potentially in the form of… more
- System One (Lakewood, CO)
- …standards (including but not limited to ISO 13485, ISO 14971, MDD, CMDR, FDA Quality System Regulations). + Extensive knowledge of US and international ... Title: Director of Product Quality (Automated Manufacturing) Location: Littleton, Co Type: Direct/Permanent...policies where appropriate + Serves as Management Representative for FDA responsibilities and holds plant manager accountable for role… more
- US Tech Solutions (San Bruno, CA)
- …standards and corporate requirements. + Regulatory Compliance: + Ensure compliance with US FDA Quality System Regulations, ISO 13485, and integration of best ... software development lifecycle, including familiarity with SDLC processes and Quality Management Systems (QMS) compliant with US FDA... Quality Management Systems (QMS) compliant with US FDA regulations and ISO 13485. + Tool Proficiency: +… more
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