Search Results: 114 vacancies
...equivalent experience
2+ years of relevant experience
Competent technical expertise and application domain knowledge
Experienced with ISO Standards, Six Sigma tools, statistics
Willing and able to travel up to 40% of the time
ASQ certification or Black Belt...
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...management
Solid understanding of budgeting, resourcing and performance evaluation procedures
Excellent knowledge of standards (e.g. ISO) and regulations for the clinical field
Proficient in MS Office and computer systems (e.g. patient management software)...
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...for virtually every industry around the globe.??Carr Lane Manufacturing?delivers consistently high-quality products and is certified ISO 9001-2015.
Carr Lane Incentives:
* Health and Wellbeing: Employer-sponsored Medical, Dental, Vision Care, Employee Assistance Program...
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Monday to Friday
...region in a designated specialized area.
Monitor laboratory compliance with respect to lab cleanliness, training records, and other ISO/GMP items to help minimize laboratory audit findings.
Participate in training and development activities in order to advance...
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Work experience placement
Local area
...shift.
The Quality Inspector is responsible for assisting in administration of the quality functions at a site to assure adherence to ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR and other applicable regulatory standards. Quality Inspectors support...
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Immediate start
Afternoon shift
...to commonly occurring problems/situations for which standards, procedures or precedents exist
Perform all tasks in accordance to ISO
QUALIFICATIONS:
Knowledge of material and tooling types
Knowledge of the machine and its capabilities, Tru-Tech,...
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Local area
Afternoon shift
Monday to Friday
...projects and initiatives from an IT Compliance perspective with cross functional teams including IT risk assessments, process automation, ISO, cybersecurity, data privacy, and application/IT security areas.
Be responsible for all IT department policies and procedures...
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...development.
+ Comprehensive understanding of U.S. and International regulations and standards for medical devices including 21 CFR 820, ISO 13485, MDR, MDSAP and other applicable standards.
+ 10+ years of Quality Assurance or related experience (utilizing quality...
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...and assembly processes.
Experience working in a regulated environment such as medical device and with a Quality Management System (ISO 9001, ISO 13485, FDA QSR, cGMP 21 CFR Part 820, ISO 14971)
Proficient with Microsoft Office Suite
Computer proficiency,...
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...Quality Assurance, to meet daily business needs.
* Complies with all GMP (Good Manufacturing Practices)
* Must comply with applicable ISO and FDA regulations as stated in Quality Manual
* Must embody the Company's Vision, Mission and Values
* Other duties may be...
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Part time
Work experience placement
...domain knowledge
• Experience with Compilers, SW Build tools, C++, Java, Python, or Jenkins
• Experience with Quality Standards (ISO, AS9100D)
• Experience with Quality tools (Six Sigma tools, statistics)
• Experience with Omnify/Empower or other PLM Tools...
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Full time
For contractors
Worldwide
Flexible hours
...inspection, product final release, calibration program, and complaint evaluation). Knowledge and experience in the application of 21CFR820, ISO 13485, MDR, MDSAP, and IEC60601. Knowledge and experience in design control and V&V for Systems, Software, components, accessories...
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...approved packaging specifications and according to safety and quality protocols. Complete appropriate packaging documentation per FDA, ISO, and GMP procedures and deliver products to inventory.
Job Functions
Fill, cap, and label chemical products
Use electronic...
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...data centers).
Establish acceptable limits for the software application, network, or system. Manage Accreditation Packages (e.g., ISO/IEC 15026-2).
Perform security reviews, identify gaps in security architecture, and develop a security risk management plan.
Perform...
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...best practices and frameworks, including (but not limited to) NIST Special Publications and Cyber Security Framework, CIS Controls, ISO/IEC 27000 series, and OWASP Top 10.
General knowledge of risk assessment methodologies.
General knowledge of laws and regulations...
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Full time
...+ Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.)
Experience Level:
Expert Level
About Actalent
Actalent is a global leader in engineering and sciences...
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...qualifications:
+ BS in Electrical Engineering , or equi valent experience, plus 0-3 years of relevant work experience .
+ Awareness of ISO, UL and CE requirements .
+ Awareness of design considerations for EMI/EMC .
+ Training/ proficiency in Microsoft Office .
+...
Work experience placement
...data analysis and data cleansing, including proficiency in SQL, Excel, and Python.
Familiarity with compliance frameworks (such as ISO standards or industry-specific regulations) is advantageous.
Attention to detail, critical thinking, and effective communication...
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...and attends daily pre-shift meetings.
Perform all duties within compliance of OSHA, company safety, and environmental regulations (ISO where applicable); including wearing appropriate PPE for task being performed.
Perform deckhand responsibilities e.g., reading...
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...for improvements to department Essex processes and procedures.
Is cognizant of all relevant regulatory requirements; import/export, ISO-14971, ISO-13485, AS-9100D, and FDA
Responsible for ensuring all direct reports have been trained to the most current engineering...
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