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Iso 11607 Jobs in Texas (NOW HIRING)

1 Resource Group

Quality & Safety Manager

Houston, TX · On-site

The Quality & Safety Manager is responsible for maintaining and improving the company's Quality Management System (ISO 9001:2015), workplace safety programs, and production quality standards. This is ...

1 Resource Group

Quality & Safety Manager

Houston, TX · On-site

The Quality & Safety Manager is responsible for maintaining and improving the company's Quality Management System (ISO 9001:2015), workplace safety programs, and production quality standards. This is ...

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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 Texas?

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

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

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

Iso 11607 jobs near you

Packaging Engineer

El Paso, TX • On-site

Becton, Dickinson and Company
Medical Equipment and Supplies Manufacturing • 10K+ employees

7.3

Company rating: 7.3 out of 10

Based on 143 frontline employees who took The Breakroom Quiz

312th of 495 rated machine equipment manufacturers

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Learn more about Becton, Dickinson and Companyexternal

Full-time

Posted 21 days ago

Job description

We are the people who give possibilities purpose
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
Job Description
The Packaging Engineer is responsible for the design, development, validation, implementation, and continuous improvement of packaging systems for medical devices manufactured at the site. This role ensures packaging solutions meet product protection, regulatory, quality, operational, and customer requirements while supporting FDA remediation activities, process optimization, product launches, and cost reduction initiatives. The Packaging Engineer collaborates closely with Manufacturing, Quality, R&D, Regulatory Affairs, Supply Chain, and external suppliers to deliver compliant and efficient packaging solutions.
Responsibilities include but are not limited to:
Packaging Design & Development
  • Design, develop, and implement primary, secondary, and tertiary packaging systems for medical device products.
  • Evaluate packaging materials, components, and configurations to ensure product protection and performance throughout the product lifecycle.
  • Support new product introductions (NPI), product transfers, and packaging changes.
  • Develop packaging specifications, drawings, bill of materials (BOMs), and technical documentation.

Validation & Regulatory Compliance
  • Develop and execute packaging validation protocols, including:

- Installation Qualification (IQ)
-Operational Qualification (OQ)
-Performance Qualification (PQ)
  • Support packaging process validation activities in compliance with:

-FDA Quality System Regulations (21 CFR Part 820)
-ISO 13485
-ISO 11607
-Good Manufacturing Practices (GMP)
  • Participate in risk assessments, FMEAs, and design reviews.
  • Ensure compliance with BD quality standards and documentation requirements.

Manufacturing Support
  • Provide engineering support for packaging operations and manufacturing processes.
  • Investigate packaging-related quality issues and implement corrective and preventive actions (CAPA).
  • Lead root cause investigations using structured problem-solving methodologies.
  • Support nonconformance investigations and continuous improvement initiatives.
  • Partner with operations teams to improve packaging efficiency, quality, and productivity.

Continuous Improvement
  • Identify and execute cost reduction and process improvement opportunities.
  • Utilize Lean Manufacturing and Six Sigma tools to improve packaging performance.
  • Drive initiatives related to waste reduction, material optimization, and operational excellence.
  • Support digitalization and automation opportunities within packaging processes.

Cross-Functional Collaboration
  • Collaborate with R&D, Product Development, Quality Assurance, Regulatory Affairs, Supply Chain, Procurement, and Manufacturing teams.
  • Interface with packaging material suppliers and contract manufacturers.
  • Support internal and external audits, including FDA inspections and customer audits.
  • Provide technical expertise on packaging-related projects and change controls.

Education & Experience
  • Bachelor's degree in Packaging Engineering, Mechanical Engineering, Industrial Engineering, Manufacturing Engineering, Biomedical Engineering, or related technical field.
  • 3+ years of engineering experience in packaging, manufacturing, medical device, pharmaceutical, or highly regulated industries.
  • Experience with packaging validation and testing methodologies.
  • Experience supporting manufacturing operations and quality systems.
  • Bilingual (English/Spanish) preferred.

Technical Skills
  • Packaging materials and technologies
  • Packaging equipment and automation systems
  • FDA regulations and GMP requirements
  • Statistical analysis and validation methodologies
  • Risk management and FMEA processes
  • Root cause analysis and CAPA systems
  • Microsoft Office Suite
  • SAP, Oracle, or similar ERP systems
  • Statistical software (Minitab preferred)
  • CAD software preferred

Key Competencies
  • Strong analytical and problem-solving skills.
  • Excellent project management abilities.
  • Effective verbal and written communication skills.
  • Ability to influence cross-functional teams.
  • Strong organizational and documentation skills.
  • Results-oriented with a continuous improvement mindset.
  • Ability to work in manufacturing and cleanroom environment

Why Join Us?
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit https://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally protected characteristics.
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Primary Work Location
USA TX - El Paso - Northwestern Dr.
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About BD

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BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

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Medical equipment and supplies manufacturing and manufacturing

Company size

10,000+ Employees

Headquarters location

Franklin Lakes, NJ, US

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