Materials testing, documentation and ISO 11607 are also preferred for this role. Personal computer skills should include the ability to effectively use Windows word processing, project planning ...
Materials testing, documentation and ISO 11607 are also preferred for this role. Personal computer skills should include the ability to effectively use Windows word processing, project planning ...
As a recognized expert, you will guide internal and external teams on the application of packaging standards (e.g., CCIT, ISO 11607, USP , USP , etc.), and represent the company in regulatory ...
As a recognized expert, you will guide internal and external teams on the application of packaging standards (e.g., CCIT, ISO 11607, USP , USP , etc.), and represent the company in regulatory ...
Ensure all designs and processes meet FDA, ISO 11607, and other global international standards, maintaining audit readiness for engineering functions. * Support the quality and regulatory processes ...
Ensure all designs and processes meet FDA, ISO 11607, and other global international standards, maintaining audit readiness for engineering functions. * Support the quality and regulatory processes ...
Ensure all designs and processes meet FDA, ISO 11607, and other global international standards, maintaining audit readiness for engineering functions. * Support the quality and regulatory processes ...
Ensure all designs and processes meet FDA, ISO 11607, and other global international standards, maintaining audit readiness for engineering functions. * Support the quality and regulatory processes ...
Ensure all designs and processes meet FDA, ISO 11607, and other global international standards, maintaining audit readiness for engineering functions. * Support the quality and regulatory processes ...
Ensure all designs and processes meet FDA, ISO 11607, and other global international standards, maintaining audit readiness for engineering functions. * Support the quality and regulatory processes ...
ISO 11607, ISO 13485, ISO 14971 Accountability: * Will not manage any direct reports. * Will not be responsible for any functional areas. * Knowledgeable and adherent to client Quality and Corporate ...
ISO 11607, ISO 13485, ISO 14971 Accountability: * Will not manage any direct reports. * Will not be responsible for any functional areas. * Knowledgeable and adherent to client Quality and Corporate ...
Be Seen First
Quality Manager - Medical Device Company
Middleton, WI · On-site
$30 - $35/hr
Strong working knowledge of ISO 13485 and FDA QSR/QMSR (21 CFR Part 820) ; familiarity with ISO 14971 (risk), ISO 10993 (biocompatibility), and ISO 11607 (sterile packaging). * ISO 13485 Lead Auditor ...
Quick apply
Be Seen First
Quality Manager - Medical Device Company
Middleton, WI · On-site
$30 - $35/hr
Strong working knowledge of ISO 13485 and FDA QSR/QMSR (21 CFR Part 820) ; familiarity with ISO 14971 (risk), ISO 10993 (biocompatibility), and ISO 11607 (sterile packaging). * ISO 13485 Lead Auditor ...
Manufacturing Lead
San Francisco, CA · On-site
Experience manufacturing disposable medical devices, including injection molding, sterile barrier packaging (ISO 11607), and EO or gamma sterilization validation * Experience developing or scaling ...
Manufacturing Lead
San Francisco, CA · On-site
Experience manufacturing disposable medical devices, including injection molding, sterile barrier packaging (ISO 11607), and EO or gamma sterilization validation * Experience developing or scaling ...
Ensure compliance with ISO 13485, ISO 11607, and internal procedures. Production & Shift Execution Own endtoend shift operations, including staffing, production flow, and issue resolution. Supervise ...
Ensure compliance with ISO 13485, ISO 11607, and internal procedures. Production & Shift Execution Own endtoend shift operations, including staffing, production flow, and issue resolution. Supervise ...
Packaging Engineer
Mansfield, MA · On-site
ISO 11607 * FDA 21 CFR Part 820 * ISO 13485 * ASTM & ISTA Packaging Standards * Experience developing technical specifications and engineering documentation. * Strong analytical, project management ...
Quick apply
Packaging Engineer
Mansfield, MA · On-site
ISO 11607 * FDA 21 CFR Part 820 * ISO 13485 * ASTM & ISTA Packaging Standards * Experience developing technical specifications and engineering documentation. * Strong analytical, project management ...
Converting Supervisor
Pleasant Prairie, WI · On-site
Ensure compliance with ISO 13485, ISO 11607, and internal procedures. Production & Shift Execution Own end-to-end shift operations, including staffing, production flow, and issue resolution.
Converting Supervisor
Pleasant Prairie, WI · On-site
Ensure compliance with ISO 13485, ISO 11607, and internal procedures. Production & Shift Execution Own end-to-end shift operations, including staffing, production flow, and issue resolution.
Working knowledge with ISO 11607 regulations and transit testing to ASTM 4169 or similar testing standards * Experience with IEC 60601 (Medical Electrical Equipment Safety and Performance ...
Working knowledge with ISO 11607 regulations and transit testing to ASTM 4169 or similar testing standards * Experience with IEC 60601 (Medical Electrical Equipment Safety and Performance ...
Senior Engineer, Packaging Engineering
$65 - $80/hr
Regulated industry packaging design Regulated industry packaging Design Verification/validation Packaging test failure RCA experience Experience with packaging testing per ISO 11607 Nice to have:
Senior Engineer, Packaging Engineering
$65 - $80/hr
Regulated industry packaging design Regulated industry packaging Design Verification/validation Packaging test failure RCA experience Experience with packaging testing per ISO 11607 Nice to have:
Packaging & Artwork Designer
Northridge, CA · On-site
$72K - $95K/yr
Ensure packaging meets global regulatory and quality standards (FDA, MDR, ISO 11607, UDI, etc.). * Collaborate cross-functionally with Regulatory Affairs, Marketing, Engineering, and Manufacturing to ...
Packaging & Artwork Designer
Northridge, CA · On-site
$72K - $95K/yr
Ensure packaging meets global regulatory and quality standards (FDA, MDR, ISO 11607, UDI, etc.). * Collaborate cross-functionally with Regulatory Affairs, Marketing, Engineering, and Manufacturing to ...
R&D Packaging Engineer - 27387
Tempe, AZ · On-site
$75 - $77/hr
Proficiency in designing and verifying packaging solutions per ISO 11607 standards. * Experience with packaging testing, failure analysis, and root cause analysis (RCA). * Strong understanding of ...
Quick apply
R&D Packaging Engineer - 27387
Tempe, AZ · On-site
$75 - $77/hr
Proficiency in designing and verifying packaging solutions per ISO 11607 standards. * Experience with packaging testing, failure analysis, and root cause analysis (RCA). * Strong understanding of ...
Systems Engineer
San Diego, CA · On-site
$90K - $120K/yr
EU MDR, TGA EP, UK AIMDD, IEC 60601-1 series, IEC 62304, IEC 62366-1, IEC 20417, ISO 10993, ISO 10974, ISO 11607, ISO 14708-1 / EN 45502-1, AAMI TIR57, 21 CFR 15, RoHS, REACH, EU RED, ETSI series ...
Systems Engineer
San Diego, CA · On-site
$90K - $120K/yr
EU MDR, TGA EP, UK AIMDD, IEC 60601-1 series, IEC 62304, IEC 62366-1, IEC 20417, ISO 10993, ISO 10974, ISO 11607, ISO 14708-1 / EN 45502-1, AAMI TIR57, 21 CFR 15, RoHS, REACH, EU RED, ETSI series ...
Senior Staff Design Quality Engineer
$86K - $117K/yr
Knowledge in one or more ISO 10993, IEC 62366, ISO 11607, ISO 11137, or ISO 11135 preferred. Work Environment: * Production/Clean Room/Warehouse/Office Environment which may require long periods of ...
Senior Staff Design Quality Engineer
$86K - $117K/yr
Knowledge in one or more ISO 10993, IEC 62366, ISO 11607, ISO 11137, or ISO 11135 preferred. Work Environment: * Production/Clean Room/Warehouse/Office Environment which may require long periods of ...
Engineering II, Packaging
Columbia, MD · Hybrid
$71K - $97K/yr
Standards include, at minimum, ISO 11607 Parts 1 and 2, ISO 13487, ISO 14971, FDA 21 CFR part 820. * Generate detailed specifications using GD&T methodologies. * Ability to prioritize multiple ...
Engineering II, Packaging
Columbia, MD · Hybrid
$71K - $97K/yr
Standards include, at minimum, ISO 11607 Parts 1 and 2, ISO 13487, ISO 14971, FDA 21 CFR part 820. * Generate detailed specifications using GD&T methodologies. * Ability to prioritize multiple ...
Design Engineer
Huntley, IL · On-site
$80K - $100K/yr
Knowledge of FDA, ISO 11607, ASTM, and ISO 13485 standards for medical packaging. * Ability to identify risks during design and commercialization phases and develop effective mitigation strategies.
Design Engineer
Huntley, IL · On-site
$80K - $100K/yr
Knowledge of FDA, ISO 11607, ASTM, and ISO 13485 standards for medical packaging. * Ability to identify risks during design and commercialization phases and develop effective mitigation strategies.
Design Engineer
Huntley, IL · On-site
$80K - $100K/yr
Knowledge of FDA, ISO 11607, ASTM, and ISO 13485 standards for medical packaging. * Ability to identify risks during design and commercialization phases and develop effective mitigation strategies.
Design Engineer
Huntley, IL · On-site
$80K - $100K/yr
Knowledge of FDA, ISO 11607, ASTM, and ISO 13485 standards for medical packaging. * Ability to identify risks during design and commercialization phases and develop effective mitigation strategies.
Iso 11607 information
See salary details
$29.5K - $39.8K
5% of jobs
$39.8K - $50K
7% of jobs
$50K - $60.3K
9% of jobs
$61.8K is the 25th percentile. Wages below this are outliers.
$60.3K - $70.6K
26% of jobs
$70.6K - $80.9K
2% of jobs
The median wage is $81.6K / yr.
$80.9K - $91.1K
15% of jobs
$91.1K - $101.4K
7% of jobs
$105.9K is the 75th percentile. Wages above this are outliers.
$101.4K - $111.7K
9% of jobs
$111.7K - $122K
10% of jobs
$122K - $132.2K
6% of jobs
$132.2K - $142.5K
4% of jobs
$29.5K
$87.7K
$142.5K
How much do iso 11607 jobs pay per year?
As of Jun 16, 2026, the average yearly pay for iso 11607 in the United States is $87,669.00, according to ZipRecruiter salary data. Most workers in this role earn between $62,500.00 and $112,500.00 per year, depending on experience, location, and employer.
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.
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Job description
Company Description
Vignesh
vignesh(dot)c(at)krgtech(dot)com
661 367 8000 * 405
Job Description
A minimum of a Bachelor's degree in engineering is required. Package Engineering degree preferred.
Minimum of three years of experience working in industry required with two years of experience in medical package development. Regulated industry experience is an asset for this role along with medical device experience.
Experience with project management is preferred.
Experience in packaging design preferred
Design verification and validation is preferred.
The ability to effectively communicate, written and verbally, technical information and its implications to non-technical staff is preferred.
The ability to apply Six Sigma and/or lean tools is an asset.
Professional judgment to generate valid solutions to technical assignments is preferred.
The ability to function independently on specific assignment objectives requiring investigation of a limited number of variables and to function effectively with limited supervision is preferred.
Having the professional judgment required to resolve technical, package design, development and/ or processing issues, identifying the timing, and understand the interrelationships of key activities are all highly preferred.
Knowledge of packaging graphics, process development validation, testing, equipment and supplier processes are preferred.
Materials testing, documentation and ISO 11607 are also preferred for this role.
Personal computer skills should include the ability to effectively use Windows word processing, project planning, presentation, e-mail and spreadsheet software is required.
The ability to create packaging documentation using CADD (Computer-Aided Drafting and Design) software is preferred.
About KRG Technologies
Sourced by ZipRecruiter
KRG Technologies was founded with a simple motive of offering the clients exactly what they want, how they want and when they want. By leveraging for its clients its technological edge and right-sourcing advantage, KRG in a short period of time has grown to become one of the most trusted strategic technology partners. Treating every client as the top priority, we customize our solutions and services to align with the unique needs of each client. Headquartered in Valencia, California, KRG employs a unique global delivery platform to minister its offerings spanning from application development and maintenance to business process reengineering. With years of hands-on domain experience and international presence, we offer state-of-the-art solutions backed by our follow-the-sun service model in the most cost effective manner. We value our clientele for the trust reposed in us and our clientele admire us for our personalized approach and deep commitment to their success. Our biggest strength lies in technical expertise of our team and individual competency of our employees, which enables us to be the most befitting solution provider.
Industry
It services
Company size
201 - 500 Employees
Headquarters location
Valencia, CA, US
Year founded
2003