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Iso 11607 Jobs (NOW HIRING)

Red Star

Sterile Packaging Manager

IN · On-site

Knowledge of applicable standards including ISO 11607, ISO 11137, relevant ASTM standards, and quality system requirements. * Experience with manufacturing processes, process validation, statistical ...

Toppan

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.

Toppan

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.

Orthofix

Packaging Engineer II

Carlsbad, NM · On-site

Familiarity with ASTM D4169, ISO 11607, and ISO 11137 PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS The physical requirements listed in this section include, but are not limited, to the motor ...

Medline

Validation Engineer

Hartland, WI

$73K - $110K/yr

Experience with ISO 13485 and ISO 11607 standards. * Experience with Measurement System Analysis. * Experience with Minitab statistical analysis software. * Experience with root cause analysis.

Amcor plc

Manufacturing Quality Engineer

New London, WI · On-site

$68K - $88K/yr

Assisting with process validations (IQ, OQ, & PQ) and product validations as per customer requirements and ISO-11607 * Support manufacturing units with analyzing failures, preventive and corrective ...

Orthofix

Packaging Engineer II

Carlsbad, CA · On-site

Familiarity with ASTM D4169, ISO 11607, and ISO 11137 PHYSICAL REQUIREMENTS / ADVERSE WORKING CONDITIONS The physical requirements listed in this section include, but are not limited, to the motor ...

Amcor

Manufacturing Quality Engineer

New London, WI

$68K - $88K/yr

Assisting with process validations (IQ, OQ, & PQ) and product validations as per customer requirements and ISO-11607 * Support manufacturing units with analyzing failures, preventive and corrective ...

Medline

Validation Engineer

Hartland, WI

$73K - $110K/yr

Experience with ISO 13485 and ISO 11607 standards. * Experience with Measurement System Analysis. * Experience with Minitab statistical analysis software. * Experience with root cause analysis.

Medline

Validation Engineer

Hartland, WI · On-site

$73K - $110K/yr

Experience with ISO 13485 and ISO 11607 standards. * Experience with Measurement System Analysis. * Experience with Minitab statistical analysis software. * Experience with root cause analysis.

Steripax Inc

Sales Engineer

Huntington Beach, CA · On-site

$80K - $90K/yr

Develop a deep understanding of flexible packaging materials, specifications, and medical industry requirements (e.g., ISO 11607, FDA regulations) to effectively support and advise customers.

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All JobsIso 11607 Jobs

Iso 11607 information

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$29.5K

$87.7K

$142.5K

How much do iso 11607 jobs pay per year?

As of Jul 14, 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?

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 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.
More about Iso 11607 jobs
What cities are hiring for Iso 11607 jobs? Cities with the most Iso 11607 job openings:
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Iso 11607 jobs near you
Infographic showing various Iso 11607 job openings in the United States as of July 2026, with employment types broken down into 1% Internship, 1% As Needed, 1% Full Time, 33% Part Time, 41% Contract, and 23% Nights. Highlights an 92% Physical, 5% Hybrid, and 3% Remote job distribution, with an average salary of $87,669 per year, or $42.1 per hour.
Sterile Packaging Manager

Sterile Packaging Manager

Red Star

IN • On-site

Full-time

Posted 25 days ago

Job description

SUMMARY: The Sterile Packaging Manager leads and oversees sterile packaging activities. This role partners cross-functionally with Regulatory, Product Development, Operations, Supply Chain, and Quality to develop and execute sterile packaging strategies from concept through commercialization and post-market support. Serving as an organizational subject matter expert, this position ensures sterile packaged products meet requirements for sterility assurance, packaging integrity, shelf life, transportation, distribution, and regulatory compliance.
The Sterile Packaging Manager provides leadership for packaging design and development, validation strategy, process controls, and technical documentation, including Design History File (DHF) requirements. The role establishes procedures and standards related to sterile packaging while leading continuous improvement initiatives and developing team members and cross-functional project teams.
ESSENTIAL DUTIES AND RESPONSIBILITIES: (includes the following but other duties may be assigned)
  • Lead the strategy, development, implementation, and lifecycle management of sterile packaging designs across product lines in partnership with product development teams to ensure packaging, labeling, and sterilization requirements are achieved.
  • Lead sterile packaging activities and provide coordination for sterilization requirements for new product introductions, design changes, and sustaining engineering initiatives.
  • Oversee the design, evaluation, and approval of packaging components and sterile packaging systems for medical device products.
  • Review, approve, and maintain packaging, labeling, and related technical documentation to ensure compliance with applicable requirements.
  • Lead risk assessment activities related to product, packaging, sterilization, and process changes to maintain sterility assurance and package integrity across all applicable entities.
  • Establish validation strategies and oversee execution of sterile packaging-related validation and verification activities, including sealing validations, OQ/PQ studies, design of experiments, transit testing, aging studies, and ongoing process monitoring.
  • Ensure effective monitoring, control, and continuous improvement of sterile packaging processes across internal and external manufacturing locations.
  • Develop and maintain procedures, business processes, work instructions, and training programs related to sterile packaging and sterilization activities.
  • Provide leadership and technical oversight for creation and approval of protocols, reports, technical justifications, and validation documentation.
  • Ensure packaging validation programs remain current, effective, and compliant at all applicable facilities.
  • Lead design transfer activities and ensure critical process parameters are defined, documented, transferred, and controlled based on process capability and risk.
  • Partner with Operations to optimize sterile packaging equipment, manufacturing processes, and production readiness while providing technical consultation to contract manufacturing partners and customers as needed.
  • Manage sterile packaging project timelines, priorities, and resource allocation to support business objectives and product launch commitments.
  • Lead investigations and corrective actions associated with post-market surveillance signals, nonconformances, and quality events related to sterile packaging.
  • Represent sterile packaging functions during customer, internal, regulatory, and certification audits.
  • Supervise, coach, and develop assigned team members and provide leadership to cross-functional project teams.

QUALIFICATION REQUIREMENTS:
  • Bachelor's degree in Packaging Engineering, Packaging Science, Engineering, or related technical discipline.
  • Minimum 5-7 years of progressive experience in sterile packaging within medical device, pharmaceutical, or related regulated industry; medical device experience strongly preferred.
  • Previous experience leading projects, initiatives, teams, or direct reports preferred.

OTHER SKILLS and ABILITIES:
  • Strong leadership, project management, and cross-functional collaboration skills.
  • Knowledge of applicable standards including ISO 11607, ISO 11137, relevant ASTM standards, and quality system requirements.
  • Experience with manufacturing processes, process validation, statistical analysis, and risk management methodologies.
  • Ability to influence decision-making and drive execution across multiple stakeholders and facilities.

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