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Iso 11607 Jobs in Texas (NOW HIRING)

Air Distribution Technologies, Inc.

Quality

El Paso, TX · On-site

Incoming Material Inspection (ISO 9001: 8.4, 8.6) * Perform receiving inspections on raw materials, components, and supplier-provided parts. * Verify compliance against PO requirements, engineering ...

Zimmer, Inc.

Quality Sr Engineer II

Austin, TX · On-site

$87K - $118K/yr

This role ensures compliance with FDA, ISO 13485, and ISO 14971 requirementsthroughout product development and design transfer. The Senior QE II partners with R&D, Systems, andElectrical/Mechanical ...

Dover Corporation

Quality Supervisor

Houston, TX

Ensure compliance with ISO standards, quality procedures, work instructions, and customer-specific requirements. * Coordinate and lead internal audits, external audits, customer audits, and ...

Synapse - Manufacturing

Quality Engineer

Greenville, TX · On-site

$70K - $90K/yr

Provides technical support for the development and implementation of ISO 9000 Quality Management systems in a Lean Continuous Process Improvement environment. Also, to provide quality engineering ...

Printpack

Quality Manager

Grand Prairie, TX

Lead and continuously improve ISO 9001 & ISO 22000 Quality Management Systems * Oversee QC Lab operations, calibration programs, and test method development * Drive customer complaint resolution ...

Dover Corporation

Quality Supervisor

Houston, TX

Ensure compliance with ISO standards, quality procedures, work instructions, and customer-specific requirements. * Coordinate and lead internal audits, external audits, customer audits, and ...

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All JobsIso 11607 JobsIso 11607 Jobs in Texas

Iso 11607 information

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 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 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 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

ISO Systems Engineer (G-Project)

Foxconn Industrial Internet - FII

Houston, TX • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Re-posted 9 days ago

Job description

Locations: Houston (IB3)   
Business Units: CESBG   
Job Classification: Exempt   
Summary
The ISO 9001 Systems Engineer supports the implementation, maintenance, and continuous improvement of the Quality Management System (QMS) while ensuring compliance with ISO 9001 standards and customer requirements. This role collaborates with Engineering, Manufacturing, Production, and cross-functional teams to improve product quality, optimize processes, resolve quality issues, and drive continuous improvement initiatives.
Key Responsibilities
• Support and maintain the Quality Management System (QMS), including procedures, work instructions, records, and quality documentation.
• Investigate production deviations, defects, and nonconformances; perform root cause analysis and implement effective corrective and preventive actions (CAPA).
• Monitor CAPA activities to ensure timely completion and verification of effectiveness.
• Analyze quality metrics, including First Pass Yield (FPY), defect trends, scrap, and rework data, to identify improvement opportunities.
• Support manufacturing process improvements, new product introductions (NPI), process validations, and production readiness activities.
• Provide quality support for manufacturing documentation, process controls, measurement systems, and engineering changes.
• Participate in internal audits and support compliance with ISO 9001, ISO 14001, ISO 27001, ISO 45001, and ESD-controlled manufacturing requirements.
• Develop quality reports, improvement plans, and data-driven recommendations based on customer feedback and quality performance metrics.
• Collaborate with Engineering, Manufacturing, Production, and customer-facing teams to resolve issues and improve product reliability and process efficiency.
• Promote a quality-focused culture through continuous improvement and adherence to company quality policies.
Basic Qualifications
• Experience with Quality Management Systems (QMS), ISO 9001 standards, and manufacturing quality processes.
• ISO certification or formal ISO training preferred (such as ISO 9001 Internal Auditor, Lead Auditor, or related quality certification).
• Knowledge of internal audits, CAPA, root cause analysis, and continuous improvement methodologies.
• Strong analytical, problem-solving, and organizational skills with attention to detail.
• Ability to interpret quality data, manage documentation, and implement effective process improvements.
• Strong communication skills with the ability to collaborate across engineering, manufacturing, production, and customer-facing teams.
Preferred Qualifications
• Experience with ISO 14001, ISO 27001, ISO 45001, Lean Manufacturing, Six Sigma, and ESD requirements is preferred.
Education and Experience
• Bachelor’s degree in Engineering, Quality, Manufacturing, Business Administration, or a related technical/business discipline.
Why Join Us
• Comprehensive benefits package including medical, dental, and vision insurance coverage.
• Basic life insurance and short-term disability coverage provided by employer.
• Supplemental life insurance and long-term disability coverage options available.
• 401K with employer contribution.
• Personal, Vacation, and Holiday paid time off for all full-time employees.
Our company is an Equal Opportunity Employer (EOE). All qualified candidates will receive consideration without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, or marital status in accordance with applicable federal, state and local laws.
 

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