- GCG (Chesapeake, VA)
- …but not limited to, production procedures, forklift operations, and OSHA and ISO requirements + Perform daily production audits and monthly department ISO ... quality audits + Identify, generate, monitor, and report on facility metrics + Track and resolve customer quality issues + Maintain a safe, clean, and healthy work environment + Other duties as assigned **What you'll bring** + 5+ years of Operations… more
- Motion Recruitment Partners (Lake Forest, CA)
- …+ Document and execute all V&V tests compliant to medical device QSR, ISO 13485. Prepare clearly written, accurate, highly detailed Safety verification test plans ... of commonly used safety equipment, and calibration procedures. + Working knowledge of ISO 14971 Risk Management for Medical Devices in medical device products safety… more
- BRECOflex CO., LLC (Eatontown, NJ)
- …intelligence (EQ) and team-oriented mindset Preferred + Lean Manufacturing and/or ISO 9001 experience + Background in industrial, packaging, or drive-component ... belts and drive components, serving diverse industries since 1989. As an ISO -certified company, we prioritize innovation, quality and continuous improvement in a… more
- PCI Pharma Services (Bedford, NH)
- …and report writing **You'll Stand Out If You Have:** + In-depth understanding of ISO cleanroom classifications and GMP clean utility systems + Strong knowledge of US ... to work across NH PCI sites, including remote locations + Ability to gown for ISO -classified cleanroom work + Ability to lift up to 20 lbs + Occasional off-shift… more
- EnerSys Energy Products, Inc (Horsham, PA)
- …Investigates, tests, and implements process improvements in a controlled AS9100 and ISO 13485 certified facility. Monitors production scrap rates and actively works ... Prior experience in lean manufacturing. + Experience in AS9100 + Experience in ISO 13485 Competencies + Rockwell Automation Studio 5000 + Solid modeling, SolidWorks… more
- Cordis (Miami Lakes, FL)
- …balloon films. + Lead process validation (IQ/OQ/PQ) activities, ensuring compliance with ISO 13485 and FDA QSR requirements. + Troubleshoot and resolve extrusion ... design, and equipment setup. + Experience with cleanroom manufacturing and compliance to ISO 13485 and FDA 21 CFR Part 11/QSR. + Proficiency with statistical… more
- Aerotek (Troy, PA)
- …assemblies meet engineering specifications, customer requirements, industry standards, and ISO 9001 quality management system requirements. The QC Manager leads ... on established inspection criteria. + Serve as the management representative for ISO 9001, ensuring ongoing compliance with all requirements. + Maintain, update, and… more
- GCG (Leominster, MA)
- …personnel and communicate this to the Director of Operations + Assure conformance to ISO 9001-2015 + Member of MRB team after 6 months in position, if required ... or experience in cable, harness assembly, and electronic components/systems is a plus + ISO 9001 experience is a plus **What We Offer** + **Competitive annual salary… more
- Fujifilm (Lexington, MA)
- …and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all other applicable laws, regulations, and ... regulations and guidelines, governmental requirement practices (GMP, GCP, GLP, GVP, ISO ) and other international clinical, regulatory requirements. + Knowledge of… more
- Actalent (Des Moines, IA)
- …The technician will adhere to quality measures that meet or exceed ISO /IEC, government regulatory (cGMP, GLP), and company requirements relevant to assigned duties. ... Adhere to quality measures to meet or exceed the standards set by ISO /IEC, government regulatory (cGMP, GLP), and company requirements. + Comply with health, safety,… more
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