Will work with the Quality Manager on ISO-related projects, perform root-cause analyses, and participate in internal quality audits. Strong welding/electrical standards knowledge and proficiency with ...
Will work with the Quality Manager on ISO-related projects, perform root-cause analyses, and participate in internal quality audits. Strong welding/electrical standards knowledge and proficiency with ...
Working knowledge of IATF 16949, ISO 9001, and/or ISO 14001 quality systems * Experience with root cause analysis and process improvement methodologies * Proficiency with SPC, PFMEA, control plans ...
Quick apply
Working knowledge of IATF 16949, ISO 9001, and/or ISO 14001 quality systems * Experience with root cause analysis and process improvement methodologies * Proficiency with SPC, PFMEA, control plans ...
Quality Manager
$100K - $120K/yr
Experience managing ISO 9001 Quality Management Systems * Experience leading customer audits and certification audits * Strong knowledge of root cause analysis (8D, 5 Why, Fishbone, PFMEA)
Quick apply
Quality Manager
$100K - $120K/yr
Experience managing ISO 9001 Quality Management Systems * Experience leading customer audits and certification audits * Strong knowledge of root cause analysis (8D, 5 Why, Fishbone, PFMEA)
Quality Control Engineer
$69K - $103K/yr
Conduct audits of processes, procedures, and systems to identify improvement opportunities and ensure compliance with quality standards (e.g., ISO 9001, GMP). * Support training efforts and ...
Quality Control Engineer
$69K - $103K/yr
Conduct audits of processes, procedures, and systems to identify improvement opportunities and ensure compliance with quality standards (e.g., ISO 9001, GMP). * Support training efforts and ...
Quality Control Engineer
$69K - $103K/yr
Conduct audits of processes, procedures, and systems to identify improvement opportunities and ensure compliance with quality standards (e.g., ISO 9001, GMP). * Support training efforts and ...
Quality Control Engineer
$69K - $103K/yr
Conduct audits of processes, procedures, and systems to identify improvement opportunities and ensure compliance with quality standards (e.g., ISO 9001, GMP). * Support training efforts and ...
Quality Engineer I
Virginia Beach, VA · On-site
$68K - $88K/yr
Ensure compliance with applicable regulatory and quality system requirements including 21 CFR Part 820, ISO 13485, and ISO 14971 across product and process activities. * Provide Quality Engineering ...
Quality Engineer I
Virginia Beach, VA · On-site
$68K - $88K/yr
Ensure compliance with applicable regulatory and quality system requirements including 21 CFR Part 820, ISO 13485, and ISO 14971 across product and process activities. * Provide Quality Engineering ...
Quality Engineer I
Virginia Beach, VA · On-site
$68K - $88K/yr
Ensure compliance with applicable regulatory and quality system requirements including 21 CFR Part 820, ISO 13485, and ISO 14971 across product and process activities. * Provide Quality Engineering ...
Quality Engineer I
Virginia Beach, VA · On-site
$68K - $88K/yr
Ensure compliance with applicable regulatory and quality system requirements including 21 CFR Part 820, ISO 13485, and ISO 14971 across product and process activities. * Provide Quality Engineering ...
Quality Engineer I
Virginia Beach, VA · On-site
$64K - $83K/yr
Ensure compliance with applicable regulatory and quality system requirements including 21 CFR Part 820, ISO 13485, and ISO 14971 across product and process activities. * Provide Quality Engineering ...
Quality Engineer I
Virginia Beach, VA · On-site
$64K - $83K/yr
Ensure compliance with applicable regulatory and quality system requirements including 21 CFR Part 820, ISO 13485, and ISO 14971 across product and process activities. * Provide Quality Engineering ...
Quality Engineer I
$64K - $83K/yr
Ensure compliance with applicable regulatory and quality system requirements including 21 CFR Part 820, ISO 13485, and ISO 14971 across product and process activities. * Provide Quality Engineering ...
Quick apply
Quality Engineer I
$64K - $83K/yr
Ensure compliance with applicable regulatory and quality system requirements including 21 CFR Part 820, ISO 13485, and ISO 14971 across product and process activities. * Provide Quality Engineering ...
Quality Engineer
Lynchburg, VA · On-site
$70K - $90K/yr
Medical Components ISO 13485; Aerospace AS9100; Consumer Products ISO 9001. This role must comply with all TPS policies, SOP's, cGMP and Management System requirements. Job Duties: * Quality Control ...
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Quality Engineer
Lynchburg, VA · On-site
$70K - $90K/yr
Medical Components ISO 13485; Aerospace AS9100; Consumer Products ISO 9001. This role must comply with all TPS policies, SOP's, cGMP and Management System requirements. Job Duties: * Quality Control ...
Quality Engineer
Lynchburg, VA · On-site
$70K - $90K/yr
Medical Components ISO 13485; Aerospace AS9100; Consumer Products ISO 9001. This role must comply with all TPS policies, SOP's, cGMP and Management System requirements. Job Duties: * Quality Control ...
Quick apply
Quality Engineer
Lynchburg, VA · On-site
$70K - $90K/yr
Medical Components ISO 13485; Aerospace AS9100; Consumer Products ISO 9001. This role must comply with all TPS policies, SOP's, cGMP and Management System requirements. Job Duties: * Quality Control ...
Production Quality Engineer with Security Clearance
Dulles, VA · On-site
$115K - $200K/yr
Develop, implement, and maintain quality system processes aligned with ISO 13485:2016 and FDA QMSR / 21 CFR Part 820 * Quality Documentation: Author and maintain quality documentation, including SOPs ...
Production Quality Engineer with Security Clearance
Dulles, VA · On-site
$115K - $200K/yr
Develop, implement, and maintain quality system processes aligned with ISO 13485:2016 and FDA QMSR / 21 CFR Part 820 * Quality Documentation: Author and maintain quality documentation, including SOPs ...
Quality Engineer
$77K - $99K/yr
Professional certification(s) or training related to ASME NQA-1, ISO 13485, or ISO 9001 are desired. Experience * Two or more years of experience in a technical organization performing engineering or ...
Quality Engineer
$77K - $99K/yr
Professional certification(s) or training related to ASME NQA-1, ISO 13485, or ISO 9001 are desired. Experience * Two or more years of experience in a technical organization performing engineering or ...
Conduct internal audits for ISO compliance. Train auditors as required. Ensure compliance with industry regulations and standards, NIBCO safety, OSHA, environmental, and quality programs. Work with ...
Conduct internal audits for ISO compliance. Train auditors as required. Ensure compliance with industry regulations and standards, NIBCO safety, OSHA, environmental, and quality programs. Work with ...
Quality Engineer
$77K - $99K/yr
Professional certification(s) or training related to ASME NQA-1, ISO 13485, or ISO 9001 are desired. Experience * Two or more years of experience in a technical organization performing engineering or ...
Quality Engineer
$77K - $99K/yr
Professional certification(s) or training related to ASME NQA-1, ISO 13485, or ISO 9001 are desired. Experience * Two or more years of experience in a technical organization performing engineering or ...
Quality Engineer
Alexandria, VA · On-site
$77K - $99K/yr
Professional certification(s) or training related to ASME NQA-1, ISO 13485, or ISO 9001 are desired. Experience * Two or more years of experience in a technical organization performing engineering or ...
Quality Engineer
Alexandria, VA · On-site
$77K - $99K/yr
Professional certification(s) or training related to ASME NQA-1, ISO 13485, or ISO 9001 are desired. Experience * Two or more years of experience in a technical organization performing engineering or ...
Quality & Lean Lead
Richmond, VA · On-site
Ensure compliance with applicable local and international regulations, ISO standards (e.g., ISO 9001, ISO 14001, ISO 45001), and customer-specific requirements, including oversight of audits and ...
Quality & Lean Lead
Richmond, VA · On-site
Ensure compliance with applicable local and international regulations, ISO standards (e.g., ISO 9001, ISO 14001, ISO 45001), and customer-specific requirements, including oversight of audits and ...
Corporate Quality Systems Engineer
Lynchburg, VA · On-site
$66K - $83K/yr
ISO 9001:2015 updates, ISO 9001:2015 Lead Auditor Certification) * Develop Management Review Data and prepare PPT * Process Audit Coordination and assistance with Site Quality Managers (formal versus ...
Corporate Quality Systems Engineer
Lynchburg, VA · On-site
$66K - $83K/yr
ISO 9001:2015 updates, ISO 9001:2015 Lead Auditor Certification) * Develop Management Review Data and prepare PPT * Process Audit Coordination and assistance with Site Quality Managers (formal versus ...
Senior Supplier Quality Engineer
Virginia Beach, VA · On-site
$91K - $101K/yr
ISO 9001 or other industry-specific standards). * Support incoming inspection and disposition of non-conforming materials. * Lead root cause investigations and CAPA activities using structured ...
Senior Supplier Quality Engineer
Virginia Beach, VA · On-site
$91K - $101K/yr
ISO 9001 or other industry-specific standards). * Support incoming inspection and disposition of non-conforming materials. * Lead root cause investigations and CAPA activities using structured ...
Ensure compliance with applicable local and international regulations, ISO standards (e.g., ISO 9001, ISO 14001, ISO 45001), and customer-specific requirements, including oversight of audits and ...
Ensure compliance with applicable local and international regulations, ISO standards (e.g., ISO 9001, ISO 14001, ISO 45001), and customer-specific requirements, including oversight of audits and ...
Iso 11607 information
What is the difference between Iso 11607 vs Packaging Technician?
| Aspect | Iso 11607 | Packaging Technician |
|---|---|---|
| Certifications | Standards for sterile packaging | Often certified in packaging processes |
| Work Environment | Manufacturing and sterile packaging facilities | Packaging lines, production areas |
| Industry Usage | Medical device and pharmaceutical packaging | Medical device, pharmaceutical, and consumer goods |
| Primary Focus | Ensuring packaging meets sterilization and safety standards | Assembling, inspecting, and packaging products |
While Iso 11607 refers to standards for sterile packaging, a Packaging Technician focuses on executing packaging processes according to those standards. The technician ensures products are properly packaged, inspected, and ready for sterilization, aligning with Iso 11607 requirements to ensure safety and compliance.
What challenges do professionals face when working with ISO 11607 compliance?
Professionals ensuring ISO 11607 compliance often face challenges in interpreting and applying the standard’s requirements to a variety of packaging materials and processes. Keeping up with evolving regulatory expectations, conducting thorough risk assessments, and validating packaging systems can be complex and time-consuming. Collaboration with cross-functional teams including R&D, quality assurance, and manufacturing is crucial to ensure that all packaging meets both regulatory and functional standards. Additionally, maintaining detailed documentation and responding to audit findings are key parts of the role.
What is ISO 11607?
ISO 11607 is an international standard that specifies requirements and test methods for packaging materials and systems used to sterilize medical devices. It ensures that packaging maintains sterility up to the point of use and provides guidance on validation processes. The standard is divided into two parts: Part 1 covers requirements for materials and design, while Part 2 focuses on packaging process validation. Compliance with ISO 11607 is critical for manufacturers to ensure patient safety and meet regulatory requirements.
What skills and qualifications are needed to work with ISO 11607?
To thrive as an ISO 11607 Compliance Specialist, you need expertise in packaging validation, regulatory standards for sterile medical devices, and a background in engineering, quality assurance, or a related scientific field. Familiarity with technical tools such as validation protocols, statistical analysis software, and document control systems is typically required, as well as knowledge of ISO 11607-1 and ISO 11607-2 standards. Strong attention to detail, analytical thinking, and effective communication help ensure compliance and successful collaboration with cross-functional teams. These skills ensure that medical device packaging meets regulatory requirements, safeguarding patient safety and supporting product quality.
What are popular job titles related to Iso 11607 jobs in Virginia? For Iso 11607 jobs in Virginia, the most frequently searched job titles are:
What job categories do people searching Iso 11607 jobs in Virginia look for? The top searched job categories for Iso 11607 jobs in Virginia are:
Welding Quality Inspector | ISO & Continuous Improvement
Virginia Beach, VA • On-site
Full-time
Posted 15 days ago
Job description
Acoustical Sheetmetal Company LLC in Virginia Beach is seeking a Quality Welding Inspection Specialist to verify production quality against engineering drawings, use inspection checklists, and log defects. Will work with the Quality Manager on ISO-related projects, perform root-cause analyses, and participate in internal quality audits. Strong welding/electrical standards knowledge and proficiency with Excel, Word and PowerPoint are required. #J-18808-Ljbffr
About Acoustical Sheetmetal
Sourced by ZipRecruiter
Industry
Construction
Company size
201 - 500 Employees
Headquarters location
Virginia Beach, VA, US
Year founded
1994