Quality Engineer
$58K - $75K/yr
Work closely with the QC Manager to ensure plant-wide understanding of the ISO 9001 standard. * Write quality system procedures/work instructions (and provide training for these procedures). * Assist ...
Quick apply
Quality Engineer
$58K - $75K/yr
Work closely with the QC Manager to ensure plant-wide understanding of the ISO 9001 standard. * Write quality system procedures/work instructions (and provide training for these procedures). * Assist ...
Regulatory Engineer
Ball Ground, GA · On-site
$66K - $86K/yr
Participate in risk management activities in accordance with ISO 14971, including risk analyses, FMEAs, and risk control verification. * Maintain and support technical documentation, including DHFs ...
Regulatory Engineer
Ball Ground, GA · On-site
$66K - $86K/yr
Participate in risk management activities in accordance with ISO 14971, including risk analyses, FMEAs, and risk control verification. * Maintain and support technical documentation, including DHFs ...
Regulatory Engineer
Ball Ground, GA · On-site
$66K - $86K/yr
Participate in risk management activities in accordance with ISO 14971, including risk analyses, FMEAs, and risk control verification. * Maintain and support technical documentation, including DHFs ...
Regulatory Engineer
Ball Ground, GA · On-site
$66K - $86K/yr
Participate in risk management activities in accordance with ISO 14971, including risk analyses, FMEAs, and risk control verification. * Maintain and support technical documentation, including DHFs ...
Support ISO 9001 certification and surveillance audits. * Plan and participate in internal and customer. * Develop QC personnel for coverage and succession. * Coordinate raw material and ...
Support ISO 9001 certification and surveillance audits. * Plan and participate in internal and customer. * Develop QC personnel for coverage and succession. * Coordinate raw material and ...
Quality Manager
Gordon, GA · On-site
Support ISO 9001 certification and surveillance audits. * Plan and participate in internal and customer. * Develop QC personnel for coverage and succession. * Coordinate raw material and ...
Quality Manager
Gordon, GA · On-site
Support ISO 9001 certification and surveillance audits. * Plan and participate in internal and customer. * Develop QC personnel for coverage and succession. * Coordinate raw material and ...
Support ISO 9001 certification and surveillance audits. * Plan and participate in internal and customer. * Develop QC personnel for coverage and succession. * Coordinate raw material and ...
Support ISO 9001 certification and surveillance audits. * Plan and participate in internal and customer. * Develop QC personnel for coverage and succession. * Coordinate raw material and ...
Quality Manager
Augusta, GA · On-site
Support ISO 9001 certification and surveillance audits. * Plan and participate in internal and customer. * Develop QC personnel for coverage and succession. * Coordinate raw material and ...
Quality Manager
Augusta, GA · On-site
Support ISO 9001 certification and surveillance audits. * Plan and participate in internal and customer. * Develop QC personnel for coverage and succession. * Coordinate raw material and ...
Quality Manager
Atlanta, GA · On-site
ISO 13485:2016 lead auditor certification preferred. * Thorough knowledge of US FDA 21 CFR 820 Quality System Regulation and ISO 13485:2016 standards. * Strong understanding of quality management ...
Quality Manager
Atlanta, GA · On-site
ISO 13485:2016 lead auditor certification preferred. * Thorough knowledge of US FDA 21 CFR 820 Quality System Regulation and ISO 13485:2016 standards. * Strong understanding of quality management ...
ISO 13485:2016 lead auditor certification preferred. * Thorough knowledge of US FDA 21 CFR 820 Quality System Regulation and ISO 13485:2016 standards. * Strong understanding of quality management ...
ISO 13485:2016 lead auditor certification preferred. * Thorough knowledge of US FDA 21 CFR 820 Quality System Regulation and ISO 13485:2016 standards. * Strong understanding of quality management ...
Quality Manager
Atlanta, GA · On-site
ISO 13485:2016 lead auditor certification preferred. * Thorough knowledge of US FDA 21 CFR 820 Quality System Regulation and ISO 13485:2016 standards. * Strong understanding of quality management ...
Quick apply
Quality Manager
Atlanta, GA · On-site
ISO 13485:2016 lead auditor certification preferred. * Thorough knowledge of US FDA 21 CFR 820 Quality System Regulation and ISO 13485:2016 standards. * Strong understanding of quality management ...
This role sits at the intersection of quality systems and day-to-day product operations -- verifying that processes, documentation, and outputs meet regulatory requirements (FDA, ISO 13485, 21 CFR ...
Quick apply
This role sits at the intersection of quality systems and day-to-day product operations -- verifying that processes, documentation, and outputs meet regulatory requirements (FDA, ISO 13485, 21 CFR ...
Manage and maintain the site Quality Management System (QMS) in accordance with ISO 9001 requirements. * Lead internal and external quality audits and coordinate responses to audit findings. * Ensure ...
Manage and maintain the site Quality Management System (QMS) in accordance with ISO 9001 requirements. * Lead internal and external quality audits and coordinate responses to audit findings. * Ensure ...
Quality Manager
Buford, GA · On-site
Manage and maintain the site Quality Management System (QMS) in accordance with ISO 9001 requirements. * Lead internal and external quality audits and coordinate responses to audit findings. * Ensure ...
Quality Manager
Buford, GA · On-site
Manage and maintain the site Quality Management System (QMS) in accordance with ISO 9001 requirements. * Lead internal and external quality audits and coordinate responses to audit findings. * Ensure ...
This role oversees ISO 9000/9001 and other third-party accreditations (e.g., ASME), drives continuous improvement, and leads a team of quality professionals in a high-volume manufacturing environment ...
Quick apply
This role oversees ISO 9000/9001 and other third-party accreditations (e.g., ASME), drives continuous improvement, and leads a team of quality professionals in a high-volume manufacturing environment ...
This role oversees ISO 9000/9001 and other third-party accreditations (e.g., ASME), drives continuous improvement, and leads a team of quality professionals in a high-volume manufacturing environment ...
This role oversees ISO 9000/9001 and other third-party accreditations (e.g., ASME), drives continuous improvement, and leads a team of quality professionals in a high-volume manufacturing environment ...
Maintain continuous readiness for customer, regulatory, and certification audits (e.g., ISO 9001, UL, CSA) and ensure timely closure of findings. * Deploy, execute, and sustain company quality ...
Maintain continuous readiness for customer, regulatory, and certification audits (e.g., ISO 9001, UL, CSA) and ensure timely closure of findings. * Deploy, execute, and sustain company quality ...
ISO 9001 Auditor; Lean/Six Sigma Green Belt or Black Belt Years of Experience: 5-7 Years Field of Expertise: Manufacturing quality within a highavolume or continuous production environment.
ISO 9001 Auditor; Lean/Six Sigma Green Belt or Black Belt Years of Experience: 5-7 Years Field of Expertise: Manufacturing quality within a highavolume or continuous production environment.
Manufacturing Quality Manager
Thomasville, GA · On-site
This role oversees ISO 9000/9001 and other third-party accreditations (e.g., ASME), drives continuous improvement, and leads a team of quality professionals in a high-volume manufacturing environment ...
Manufacturing Quality Manager
Thomasville, GA · On-site
This role oversees ISO 9000/9001 and other third-party accreditations (e.g., ASME), drives continuous improvement, and leads a team of quality professionals in a high-volume manufacturing environment ...
Manager, Quality
Carrollton, GA · On-site
Maintain continuous readiness for customer, regulatory, and certification audits (e.g., ISO 9001, UL, CSA) and ensure timely closure of findings. * Deploy, execute, and sustain company quality ...
Manager, Quality
Carrollton, GA · On-site
Maintain continuous readiness for customer, regulatory, and certification audits (e.g., ISO 9001, UL, CSA) and ensure timely closure of findings. * Deploy, execute, and sustain company quality ...
Quality Supervisor | Manufacturing
$67K - $70K/yr
Ensure products consistently meet company, customer, and ISO 9001:2015 requirements * Review inspections, testing results, and production documentation prior to product release * Lead investigations ...
New
Quick apply
Quality Supervisor | Manufacturing
$67K - $70K/yr
Ensure products consistently meet company, customer, and ISO 9001:2015 requirements * Review inspections, testing results, and production documentation prior to product release * Lead investigations ...
New
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 are the main challenges faced by professionals working with ISO 11607 compliance in medical device packaging?
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 are the key skills and qualifications needed to thrive as an ISO 11607 Compliance Specialist, and why are they important?
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 Georgia? For Iso 11607 jobs in Georgia, the most frequently searched job titles are:
What job categories do people searching Iso 11607 jobs in Georgia look for? The top searched job categories for Iso 11607 jobs in Georgia are:
What cities in Georgia are hiring for Iso 11607 jobs? Cities in Georgia with the most Iso 11607 job openings:
$58K - $75K/yr
Full-time
Posted 25 days ago
Job description
Overview:
The Quality Engineer will work side by side with Manufacturing and Engineering to ensure compliance to the company's designs, ASME standards, and customer requirements. As part of the quality group, there will be an emphasis on driving improvement. The qualified candidate in this role will focus on continuous improvement projects, data entry/analysis, and assisting with the maintenance of ISO documents/standards.
Responsibilities:
- Lead/manage continuous improvement projects.
- Work closely with the QC Manager to ensure plant-wide understanding of the ISO 9001 standard.
- Write quality system procedures/work instructions (and provide training for these procedures).
- Assist with disposition and documentation of nonconforming material.
- Assist with management of the supplier quality program (conducting supplier audits as needed).
- Consult with plant management and personnel on better operational procedures to improve overall safety, quality, delivery, and cost.
- Problem solving/root cause analysis and implementation of corrective actions.
- Function as an information source for all personnel when quality issues arise.
- Participate in ISO and ASME audits.
- Assist with management of internal audit program.
- Complete ASME Data Reports, as required.
- Assist with calibration schedules and procedures for critical gauges/equipment.
Qualifications:
- Bachelor’s Degree in Engineering or other related discipline
- Prefer to have experience reading mechanical drawings and/or wiring diagrams
- Prefer to have exposure to ISO 9001 or other Quality Management System Standard
- Proficient in Microsoft Office
- ERP experience a plus