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Iso 11607 Jobs in Nebraska (NOW HIRING)

Owen Industries

QUALITY ENGINEER

Wahoo, NE · On-site

$69K - $89K/yr

Lead and participate in internal ISO audits and support third-party audits (registrars and customers) * Manage supplier quality , including assessments, corrective actions, and coordination of third ...

Parker

Quality Manager I

Kearney, NE · On-site

Enhance and improve the Division's products and services through the implementation of ISO 9001, problem-solving tools, prevention methods, quality-at-the-source and continual improvement techniques.

Parker Hannifin Corp.

Quality Manager I

Kearney, NE · On-site

Enhance and improve the Division's products and services through the implementation of ISO 9001, problem-solving tools, prevention methods, quality-at-the-source and continual improvement techniques.

Parker Hannifin Corp.

Quality Manager I

Kearney, NE · On-site

Enhance and improve the Division's products and services through the implementation of ISO 9001, problem-solving tools, prevention methods, quality-at-the-source and continual improvement techniques.

Parker Hannifin Corp.

Quality Manager I

Kearney, NE

Enhance and improve the Division's products and services through the implementation of ISO 9001, problem-solving tools, prevention methods, quality-at-the-source and continual improvement techniques.

Ethos

Senior Quality Engineer

Omaha, NE · On-site

$84K - $114K/yr

Senior Quality Engineer In this role, you'll partner with cross-functional teams, suppliers, and customers to improve processes, maintain ISO 9001 standards, lead quality improvement efforts, and ...

Ethos

Senior Quality Engineer

Omaha, NE · On-site

$84K - $114K/yr

Senior Quality Engineer In this role, you'll partner with cross-functional teams, suppliers, and customers to improve processes, maintain ISO 9001 standards, lead quality improvement efforts, and ...

Ethos

Senior Quality Engineer

Omaha, NE · On-site

$84K - $114K/yr

Senior Quality Engineer In this role, you'll partner with cross-functional teams, suppliers, and customers to improve processes, maintain ISO 9001 standards, lead quality improvement efforts, and ...

H. T. PROF Group

Senior Quality Engineer

Omaha, NE · On-site

$85 - $120/hr

In this role, you'll partner with cross-functional teams, suppliers, and customers to improve processes, maintain ISO 9001 standards, lead quality improvement efforts, and champion a culture of ...

embecta

Quality Engineer

Holdrege, NE · On-site

$86K - $111K/yr

... ISO 13485. § Project Management experience. embecta is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed ...

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All JobsIso 11607 JobsIso 11607 Jobs in Nebraska

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 Nebraska?

For Iso 11607 jobs in Nebraska, the most frequently searched job titles are:

What job categories do people searching Iso 11607 jobs in Nebraska look for?

The top searched job categories for Iso 11607 jobs in Nebraska are:

Iso 11607 jobs near you

QUALITY ENGINEER

Owen Industries

Wahoo, NE • On-site

$69K - $89K/yr

Part-time

Re-posted 14 days ago

Job description

Quality Engineer

Location: Wahoo, NE

Omaha Steel is seeking a Quality Engineer to support and strengthen our quality systems, supplier quality, and customer satisfaction efforts. This role plays a key part in ensuring our manufacturing processes, welding programs, and supplier operations meet or exceed ISO and customer requirements.

We’re open to candidates with formal education, hands-on experience, or a strong combination of both in quality engineering, manufacturing, or metallurgical environments.

What You’ll Do

  • Support and continuously improve the company’s quality management system, ensuring compliance with ISO 9001 and applicable industry standards
  • Lead and participate in internal ISO audits and support third-party audits (registrars and customers)
  • Manage supplier quality, including assessments, corrective actions, and coordination of third-party supplier audits
  • Maintain and control quality documentation in accordance with ISO requirements
  • Review and prepare customer regulatory declarations (e.g., 3TG, REACH, RoHS, Prop 65, Certificates of Origin)
  • Support and document welding programs, including welder qualifications and compliance with customer specifications
  • Work closely with engineering and technical teams on alloy selection, welding processes, heat treat, and nondestructive testing
  • Lead or support root cause analysis and corrective actions for customer complaints and internal quality issues
  • Participate in new product development activities including First Article inspections and PPAP submissions
  • Assist with internal scrap review, RMAs, and quality reporting
  • Analyze quality data and trends to drive continuous improvement initiatives

What We’re Looking For

  • Experience in a quality, manufacturing, or metalworking environment
  • Working knowledge of ISO 9001 or similar quality systems
  • Ability to read and interpret codes, standards, and technical specifications
  • Familiarity with welding processes and inspection practices (CWI a plus, not required)
  • Experience or training in NDT methods such as:
    • Liquid Penetrant Testing (PT)
    • Magnetic Particle Testing (MT)
  • Understanding of metrology and use of measuring equipment (calipers, micrometers, CMMs, etc.)
  • Strong analytical, problem-solving, and organizational skills
  • Ability to communicate effectively across shop-floor, technical, and customer-facing teams

Education & Experience

  • Associate’s or Bachelor’s degree in Engineering, Materials Science, Metallurgy, or a related field preferred but not required
  • Equivalent hands-on quality or manufacturing experience will be considered in place of formal education

Work Environment & Physical Requirements

  • Manufacturing and foundry environment
  • Standing, walking, bending, and lifting up to 50 lbs as needed
  • Exposure to heat, fumes, uneven surfaces, and industrial conditions
  • Occasional driving and interaction with production areas

Why Join Omaha Steel

  • Be part of a technically driven quality team with real influence on processes
  • Work closely with engineering, production, and customers
  • Stable operation with long-term manufacturing programs
  • Opportunity to grow certifications, technical skills, and leadership responsibilities
  • Culture that values accountability, problem-solving, and continuous improvement

If you’re a hands-on Quality Engineer who understands manufacturing realities and wants to make a measurable impact, we’d like to hear from you.

Apply today and help us build quality into everything we do.

We Proudly Support and Welcome Veterans!

We value the experience, skills, and dedication that Veterans bring to our team. As a Veteran-friendly company, we are committed to providing opportunities and a supportive environment for those who have served.

AAP/EEO Statement

Owen is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All employment decisions are based on qualifications, merit, and business needs. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.