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$100.1k - $150.2k
...professional attitude, and strong customer service skills ~ Knowledge of one or more quality systems: i.e., Malcolm Baldridge, ISO 9000, Lean, Kaizen, Army Corps of Engineers, Mortenson’s Quality System, continuous improvement, value streams, etc. ~ Experience...SuggestedH1bWork at officeFlexible hours$100.1k - $150.2k
...professional attitude, and strong customer service skills ~ Knowledge of one or more quality systems: i.e., Malcolm Baldridge, ISO 9000, Lean, Kaizen, Army Corps of Engineers, Mortenson’s Quality System, continuous improvement, value streams, etc. ~ Experience...SuggestedH1bWork at officeWork visaFlexible hours- Cloquet is currently looking for an ISO Coordinator with a focus on ISO systems management and continuous improvement. This position is for an individual who can become proficient with mill data systems, working closely with a variety of functional groups within the organization...SuggestedWork at office
- ...Qualifications* Experience in the medical device, pharmaceutical, aerospace, automotive, or highly regulated industry.* Knowledge of FDA, ISO 13485, IEC 60601, ISO 14971, or other applicable industry standards.* Experience with Minitab, JMP, ReliaSoft, MATLAB, or similar...Suggested
- ...regulations associated with Materials of Concern, Biocompatibility and Hazardous Substances ((e.g. RoHS, EU MDR, California Prop. 65, ISO 10993)Knowledge and experience of Materials Characterization TechniquesCan you please confirm the 3 main responsibilities/day to day...SuggestedFor subcontractor
- ...Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), and ISO 13485Can you please confirm the 3 main responsibilities/day to day activities required for this role?Perform process and component/...Suggested
$129.3k - $258.7k
...Operations leadership to address compliance risks and regulatory requirements.Ensure quality activities comply with FDA regulations, ISO 13485, and other applicable global standards.Cross-Functional CollaborationPartner with Manufacturing, Engineering, Product Development...SuggestedLocal areaWorldwide- ...actions.Contribute to a culture of continuous improvement, safety, and compliance with quality and regulatory requirements (including ISO 13485 and FDA expectations).Must?Have: Minimum RequirementsBachelor’s degree in Engineering (Mechanical, Welding, Materials,...Suggested
$132k - $198k
...identify and address product security risks. Familiarity with medical device cybersecurity standards and guidance, including IEC 81001-5-1, ISO 14971, and FDA premarket and post‑market cybersecurity guidance. Experience supporting FDA and other regulatory cybersecurity...SuggestedFull timeH1bWork at officeLocal areaImmediate startFlexible hours- ...environmentBasic to intermediate computer skillsPreferred: MN Boiler License, Previous experience in a precision fabrication shop, Familiarity with ISO 9001 standardsPhysical RequirementsLift and carry up to 50 lbs regularlyWork in standing, kneeling, and overhead positionsExposure to...Suggested
- ...to regional markets and customer needs. The company is committed to developing eco-sustainable, eco-compatible products and maintains ISO 9001 and ISO 14001 certified facilities. In the U.S., MAPEI is a member of the U.S. Green Building Council and offers technical...Suggested
$19 per hour
...our manufacturing team on 3rd shift. This is a great opportunity for candidates with quality, manufacturing, food production, GMP, or ISO compliance experience who are looking to grow their careers in a fast-paced production environment. Responsibilities Perform...SuggestedWork at officeShift workNight shiftResourceMFG
Minnesota20 hours ago$70k - $85k
...departments to support regulatory, ordering, inspection, manufacture and promotion of new products and product modifications. Support all ISO documentation and procedures to ensure compliance. Provide engineering support to other departments as required (i.e. Marketing, QA/...SuggestedLocal areaShift work- ...prioritize production schedules Strong attention to detail and quality workmanship Preferred Qualifications Familiarity with AS9100 or ISO quality systems Experience with manual lathes, grinders, or secondary machining operations Trade school certification or machinist...SuggestedFull timeApprenticeshipLocal areaShift workDay shift
$103.2k - $154.8k
...efforts for Cardiac Ablation Solutions products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO 13485. Serve as member of the extended quality team for Affera software releases used for mapping and navigation in electrophysiology...SuggestedFull timeH1bWork at officeLocal areaImmediate startWorldwideFlexible hours$74.4k - $111.6k
...functional project teams. Master of Science Degree In depth experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards Working knowledge of SaMD and SiMD Positive track...- ...Cloquet have won environmental recognition, aligning with the mill's commitment to sustainability. Cloquet is currently looking for an ISO Coordinator with a focus on ISO systems management and continuous improvement. This position is for an individual who can become...Work at officeLocal area
$80k - $120k
...Ability to collaborate effectively with cross-functional teams and external suppliers to resolve technical and quality issues.Knowledge of ISO 13485, ISO 14971, and 21 CFR Part 820 requirements.Experience applying Lean Six Sigma or DMAIC methodologies; Green Belt or Black...Full timeH1bWork at officeLocal areaImmediate startWorldwideFlexible hours- ...and collaborate with engineering and global teams to ensure timely approvals. The role requires hands-on experience with FDA guidance, ISO standards, and quality systems, with strong negotiation and communication skills. Onsite collaboration is essential to drive...
$22 - $26 per hour
...biological materials, including treated animal tissue, in accordance with established safety and regulatory protocols. Must follow cGMP, ISO, and company quality system procedures at all times. Ability to work in a highly regulated medical device manufacturing...Full timeContract workTemporary workH1bLocal areaVisa sponsorshipWork visaMonday to FridayFlexible hoursShift work- ...top boxes, gateways, and routers Good to have skills: Wireless stacks (BLE, Wi Fi, Thread, Zigbee) Edge AI DSP ISO 26262, IEC 62304, MISRA C/C++ Key Niche Skills Programming: Strong proficiency in C++ (11/14/17) for embedded...Work experience placement
$70 - $75 per hour
...organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and...Contract workTemporary workWork experience placementLocal areaRemote work$75 - $80 per hour
...organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and...Contract workTemporary workLocal areaRemote work- ...Operations Center (SOC) monitoring, incident response, threat detection, vulnerability management, along with a solid understanding of IT ISO 27001, GDPR, NIST Cybersecurity Framework, Third-Party Vendor Risk Management, and Risk Assessments. Required Skills &...Work at office3 days per week
$44 per hour
...Experience with SAP or similar ERP systems. Experience with Windchill or other document control systems. Knowledge of FDA, GMP, ISO 13485, and ISO 14971. Strong analytical, problem-solving, and cross-functional communication skills. Preferred Qualifications...Hourly payContract work- ...backlog and partners with engineering teams on prioritization and fixes. Map controls compliance frameworks (SOC 2, HIPAA, PCI, ISO 27001, NIST) and support audit evidence collection. Mid: Maintains control mappings and produces audit-ready evidence for assigned...
- ...requests Separation of duties Ensure IAM solutions align with applicable security and compliance frameworks, including SOC 2, ISO 27001, GDPR, HIPAA, and NIST. Align IAM strategy with business objectives and enterprise architecture. Develop IAM roadmaps...
- ...executive reporting on security posture, vulnerabilities, remediation metrics, risks, and program status . Ensure alignment with NIST, ISO 27001, CIS Controls , and applicable regulatory requirements. REQUIRED SKILLS ~10+ years of program/project management...
- ...and mitigate project risks, especially those related to cybersecurity. Ensure alignment with security standards and frameworks (ISO 27001, NIST, CIS, etc.). Support audit and regulatory compliance initiatives. Security Program Support Drive execution...Remote work
$90 - $95 per hour
...organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and...Contract workTemporary workLocal area
