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Iso 11607 Jobs in Georgia (NOW HIRING)

Scanfil NV

Quality and Environmental Manager

Buford, GA · On-site

$90 - $130/hr

As defined in ISO 13485, the Quality and Environmental Manager is the management representative. Q&EM is responsible for quality, environmental, and sustainability awareness and performance in the ...

Talent Tech Pro

Quality Engineer

Thomasville, GA · On-site

$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 ...

Manufacturing Company

Quality Engineer

Buford, GA · On-site

$65K - $84K/yr

... 9. ISO:9001, ISO:14001, ISO:13485 and ISO:45001 Knowledge 10. Work closely with Supervisors to ensure employees are being trained properly to perform their duties. 11. Assure production lines ...

JM Huber Corporation

Quality Manager

Augusta, GA

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 ...

JM Huber Corporation

Quality Manager

Gordon, GA

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 ...

JM Huber Corporation

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 ...

JM HUBER CORPORATION

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 ...

JM HUBER CORPORATION

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 ...

SoftWave TRT

Quality Manager

Marietta, GA · On-site

Maintain quality documentation required for FDA and ISO compliance * Support inspection readiness and regulatory audit responses * Ensure quality system documentation supports product lifecycle and ...

CorDx

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 ...

CorDx

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 ...

CorDx

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 ...

Mirion Technologies, Inc.

Quality Manager

Atlanta, GA · On-site

Assess and strengthen implementation of QA program requirements (ISO 9001:2015, 10 CFR 50 Appendix B, 10 CFR Part 21, and NQA-1). * Organize and lead internal and external audits, including ISO 9001 ...

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Iso 11607 information

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 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 the difference between Iso 11607 vs Packaging Technician?

AspectIso 11607Packaging Technician
CertificationsStandards for sterile packagingOften certified in packaging processes
Work EnvironmentManufacturing and sterile packaging facilitiesPackaging lines, production areas
Industry UsageMedical device and pharmaceutical packagingMedical device, pharmaceutical, and consumer goods
Primary FocusEnsuring packaging meets sterilization and safety standardsAssembling, 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 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:

Iso 11607 jobs near you
Infographic showing various Iso 11607 job openings in Georgia as of August 2026, with employment types broken down into 83% Full Time, 4% Part Time, 9% Contract, and 4% Nights. Highlights an 88% Physical, 4% Hybrid, and 8% Remote job distribution.

Quality and Environmental Manager

Buford, GA • On-site

Scanfil NV
See more jobs at Scanfil NVexternal

$90 - $130/hr

Other

Posted 7 days ago

Job description

Short description:

The Quality and Environmental Manager is overall responsible for the local Management system and obligated to communicate the requirements of management's responsibility in ISO 9001, ISO 14001, ISO 45001, and ISO 13485. As defined in ISO 13485, the Quality and Environmental Manager is the management representative.

Q&EM is responsible for quality, environmental, and sustainability awareness and performance in the factory.

Qualifications (2):

B.A and minimum 5-10 years of working experience from relevant industry. 5-10 Years of broad technical experience, 2-3 years in Quality Engineering/Administration or Process Engineering, 3+ years experience in an ISO 9001 quality environment.

Responsibilities:
  • Ensure that the organization’s Quality Management System conforms to customer, internal, ISO 9001, and regulatory/legal requirements.
  • Facilitates and leads team efforts to establish and monitor customer/supplier relations, supports strategic planning and deployment initiatives.
  • Helps develop measurement systems to determine organizational improvement.
  • Motivate and evaluate staff, manage projects and human resources, analyze financial situations, determine and evaluate risk, and employ knowledge management tools and techniques in resolving organizational challenges.
  • Ensure evaluation of, and reporting on, supplier quality systems.
  • Oversee inspection (examination) of incoming materials, ensuring that they meet requirements.
  • Manage the monitoring, measurement, and review of internal processes, especially those that affect the quality of the organization’s products and quality management system.
  • Work with customers, engineers, contractors, and outsourcing firms to develop product requirements.
  • Report to top management on the performance of the QMS (e.g., results of quality audits, corrective actions), including the need for improvement.
  • Conduct periodic management review meetings.
  • Responsible for accuracy and timely inspection/calibration of monitoring and measuring devices and determining if the correct tools are being used.
  • Keep up on standards, regulations/laws, issues, and news with respect to product (service) quality and determine if new standards are needed for the business.
  • Understanding customer needs and requirements to develop effective quality control processes
  • Devising and reviewing specifications for products or processes.
  • Setting requirements for raw material or intermediate products for suppliers and monitoring their compliance.
  • Assist in the management of the OMS/EMS/OHS system with partnership of HR and the management team as well as the safety committee.
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