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Iso 11607 Jobs in Arizona (NOW HIRING)

amphenol

Quality Manager

Mesa, AZ · On-site

Develop, maintain, and enforce quality systems, policies, and procedures to ensure compliance with company standards, customer specifications, and applicable regulations (e.g., ISO, AS9100, FDA, etc.

GTI Fabrication

Quality Engineer

Goodyear, AZ · On-site

$74K - $110K/yr

Support and maintain the effectiveness of the ISO 9001 Quality Management System (QMS). * Monitor, analyze, and improve production and quality processes using data-driven methodologies. * Develop and ...

GTI Fabrication

Quality Engineer

Goodyear, AZ · On-site

$74K - $110K/yr

Support and maintain the effectiveness of the ISO 9001 Quality Management System (QMS). * Monitor, analyze, and improve production and quality processes using data-driven methodologies. * Develop and ...

Corning

Quality Engineer

Glendale, AZ · On-site

$91K - $126K/yr

Led supplier quality activities to ensure compliance with ISO 9001, customer, regulatory and company requirements. * Facilitate corrective and preventive actions for issues both internal to the plant ...

Corning

Supplier Quality Engineer

Glendale, AZ · On-site

$91K - $126K/yr

Led supplier quality activities to ensure compliance with ISO 9001, customer, regulatory and company requirements. * Facilitate corrective and preventive actions for issues both internal to the plant ...

Corning

Quality Engineer

Glendale, AZ · On-site

$91K - $126K/yr

Led supplier quality activities to ensure compliance with ISO 9001, customer, regulatory and company requirements. * Facilitate corrective and preventive actions for issues both internal to the plant ...

Solestial, Inc.

Quality Manager

Tempe, AZ

Develop, implement, and maintain the company's quality management system (QMS) in line with AS9100 or ISO 9001 standards * Serve as the key quality representative during customer reviews and ...

Spartech

Quality Engineer (REQ866)

Goodyear, AZ · On-site

$70K - $90K/yr

Responsible for site certification of ISO 9001 quality system. * Coordinates Quality audits with our cooperate ISO staff and customer audits. * Oversees manufacturing-related processes, insuring they ...

Spartech

Quality Engineer (REQ866)

Goodyear, AZ · On-site

$69K - $90K/yr

Responsible for site certification of ISO 9001 quality system. * Coordinates Quality audits with our cooperate ISO staff and customer audits. * Oversees manufacturing-related processes, insuring they ...

FM Industries

Quality Engineer I

Tempe, AZ · On-site

$69K - $90K/yr

Create and maintain company quality documentation and ensure that the ISO quality system is effectively established, implemented, and maintained * Determine quality improvement parameters by ...

FM Industries

Quality Engineer I

Tempe, AZ · On-site

$69K - $90K/yr

Create and maintain company quality documentation and ensure that the ISO quality system is effectively established, implemented, and maintained * Determine quality improvement parameters by ...

Spartech

Quality Engineer (REQ866)

Goodyear, AZ · On-site

$69K - $90K/yr

Responsible for site certification of ISO 9001 quality system. * Coordinates Quality audits with our cooperate ISO staff and customer audits. * Oversees manufacturing-related processes, insuring they ...

Integrated Magnetics

Quality Engineer

Tucson, AZ · On-site

$61K - $80K/yr

Knowledge of quality management systems (QMS), such as ISO 9001 and/or AS9100 * Strong analytical and problem-solving skills. * Proficiency with quality tools and methodologies (e.g., Six Sigma, Root ...

Integrated Magnetics

Quality Engineer

Tucson, AZ · On-site

$61K - $80K/yr

Knowledge of quality management systems (QMS), such as ISO 9001 and/or AS9100 * Strong analytical and problem-solving skills. * Proficiency with quality tools and methodologies (e.g., Six Sigma, Root ...

Edmund Optics

Quality Engineer II

Tucson, AZ · On-site

$61K - $80K/yr

Maintain and improve elements of the Quality Management System in accordance with ISO 9001, ISO 14001, AS9100, ISO13485, and other applicable standards. * Support internal and external audits by ...

Edmund Optics

Quality Engineer II

Tucson, AZ

$61K - $80K/yr

Maintain and improve elements of the Quality Management System in accordance with ISO 9001, ISO 14001, AS9100, ISO13485, and other applicable standards. * Support internal and external audits by ...

Edmund Optics

Quality Engineer II

Tucson, AZ · On-site

$61K - $80K/yr

Quality Systems & Compliance Maintain and improve elements of the Quality Management System in accordance with ISO 9001, ISO 14001, AS9100, ISO13485, and other applicable standards. * Support ...

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Showing results 21-40

All JobsIso 11607 JobsIso 11607 Jobs in Arizona

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.
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Iso 11607 jobs near you

Quality Manager

amphenol

Mesa, AZ • On-site

Other

Re-posted 11 days ago

Job description

Position Summary:

The Quality Manager is responsible for developing, implementing, and maintaining the company’s quality systems and processes to ensure products and services meet customer, regulatory, and internal requirements. This role oversees all quality assurance and control activities and leads continuous improvement efforts across departments.

Essential Duties and Responsibilities:

  • Lead and manage the Quality department, including supervision of quality technicians, inspectors, and auditors
  • Develop, maintain, and enforce quality systems, policies, and procedures to ensure compliance with company standards, customer specifications, and applicable regulations (e.g., ISO, AS9100, FDA, etc.)
  • Oversee inspections, audits, testing, and root cause analysis of non-conformances; develop corrective and preventive actions
  • Collaborate with Engineering, Production, and Supply Chain teams to identify quality concerns and drive resolution
  • Lead internal and external audits, manage documentation, and prepare audit reports
  • Train employees on quality standards, procedures, and expectations across the organization
  • Monitor quality performance metrics and trends; report findings to leadership and recommend improvements
  • Manage supplier quality, including vendor audits, incoming inspection protocols, and performance tracking
  • Maintain control of quality documentation including work instructions, standard operating procedures, and inspection records
  • Promote a culture of quality, accountability, and continuous improvement across all levels of the organization

Qualifications:

Required:

  • Bachelor’s degree in Quality, Engineering, or a related field
  • 5+ years of experience in quality management, preferably in a manufacturing or industrial environment
  • Strong knowledge of quality systems and standards (e.g., ISO 9001, AS9100, IATF 16949, etc.)
  • Experience with root cause analysis tools (e.g., 8D, Fishbone, 5 Whys) and CAPA processes
  • Proficiency in Microsoft Office and quality data/reporting tools
  • Strong analytical, communication, and leadership skills

Preferred:

  • Quality certifications (e.g., CQE, CQA, Six Sigma, Lean)
  • Experience with ERP or quality management systems (QMS software)

Knowledge, Skills, and Abilities:

  • Strong leadership and team development skills
  • Excellent problem-solving and decision-making ability
  • Detail-oriented with strong organizational skills
  • Effective written and verbal communication
  • Ability to interpret technical drawings/specifications
  • Familiarity with inspection tools and measurement systems

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