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Iso 11607 Jobs in California (NOW HIRING)

XLR8 EMS

Quality Systems Engineer

San Diego, CA · On-site

Maintain compliance with ISO 13485, AS9100, ISO 9001, ITAR, and customer-specific requirements. * Develop, revise, review, and control quality system procedures, policies, forms, and records.

SaniSure LLC

Supplier Quality Engineer

Camarillo, CA · On-site

$95K - $105K/yr

Ensure suppliers meet ISO 13485 and FDA QSR/QMSR expectations. Supplier Auditing and Oversight * Plan and execute supplier audits in accordance with risk-based audit schedules. * Evaluate compliance ...

Astrix Inc

Quality Engineer II

Irvine, CA · On-site

$77K - $99K/yr

Ensure compliance with ISO 13485, ISO 14971, GxP, SOPs, and applicable regulatory requirements. Minimum Qualifications: * Bachelor's degree in Engineering, Life Sciences, or related technical field ...

hyve solutions

Quality Engineer Technician

Fremont, CA · On-site

$78K - $101K/yr

Assists with the preparation of ISO Documentation and document management * Maintains files for the department * Must be flexible in their approach to work and tasks to meet the needs of the business.

Hyve Solutions

Quality Engineer Technician

Fremont, CA

$78K - $101K/yr

Assists with the preparation of ISO Documentation and document management * Maintains files for the department * Must be flexible in their approach to work and tasks to meet the needs of the business.

Balda C Brewer

Quality Manager

Ontario, CA · On-site

$140K - $180K/yr

Lead customer audits, ISO audits and Internal audits * Achieve financial objectives (maintain department salaries within budget, prepare the Quality budget, schedule the expenditures) * Follow and ...

SirenOpt

Quality Manager

San Leandro, CA · On-site

What You'll Do QMS Design & ISO 9001 Certification * Design, implement, and maintain a QMS aligned with ISO 9001:2015 requirements * Lead the company through initial ISO 9001 certification, including ...

CYNET SYSTEMS

Inspector II

Rancho Cucamonga, CA · On-site

$26.26 - $31.26/hr

Knowledge of AS9100D/AS9120B/ISO 9001-15 standards. Responsibilities: Read, understand and practice customer standards and specifications. Read, understand and practice industry standards and ...

CYNET SYSTEMS

Inspector II

Rancho Cucamonga, CA · On-site

$26 - $31/hr

Knowledge of AS9100D/AS9120B/ISO 9001-15 standards. Responsibilities: * Read, understand and practice customer standards and specifications. * Read, understand and practice industry standards and ...

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Showing results 21-40

All JobsIso 11607 JobsIso 11607 Jobs in California

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 California?

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

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

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

What cities in California are hiring for Iso 11607 jobs?

Cities in California with the most Iso 11607 job openings:

Iso 11607 jobs near you
Infographic showing various Iso 11607 job openings in California as of August 2026, with employment types broken down into 92% Full Time, 2% Part Time, 4% Contract, and 2% Nights. Highlights an 88% Physical, 4% Hybrid, and 8% Remote job distribution.

Quality Systems Engineer

XLR8 EMS

San Diego, CA • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 5 days ago

Job description

Position Summary

The Quality Systems Engineer is the primary owner and administrator of the XLR8 EMS Quality Management System (QMS). This role is responsible for maintaining, monitoring, and continuously improving the company's quality system to ensure compliance with ISO 13485, AS9100, ISO 9001, ITAR, customer requirements, and applicable regulatory standards. The position is focused exclusively on quality system management, compliance, audits, document control, CAPA administration, training compliance, and certification maintenance, and does not have responsibility for manufacturing process quality, supplier quality, inspection activities, or product quality engineering.

Key Responsibilities

  • Maintain compliance with ISO 13485, AS9100, ISO 9001, ITAR, and customer-specific requirements.
  • Develop, revise, review, and control quality system procedures, policies, forms, and records.
  • Manage document control processes, revision control, approvals, distribution, and record retention.
  • Develop and execute the internal audit program and conduct system and compliance audits.
  • Coordinate registrar, customer, and regulatory audits and ensure audit readiness.
  • Administer the Corrective and Preventive Action (CAPA) system, including tracking, closure, and effectiveness verification.
  • Support Management Review activities and prepare quality system performance metrics and reports.
  • Maintain employee training matrices, competency records, and quality system training compliance.
  • Monitor and implement changes related to quality standards, regulatory requirements, and customer requirements.
  • Administer and maintain electronic quality management systems (eQMS) and related quality databases.
  • Drive continual improvement of quality system processes and overall compliance effectiveness.

Required Qualifications

  • Bachelor's degree in Engineering, Quality, Regulatory Affairs, Industrial Technology, or related field.
  • 3–7 years of experience in Quality Systems, Quality Assurance, or Compliance within a regulated manufacturing environment.
  • Working knowledge of ISO 13485, AS9100, ISO 9001, and ITAR requirements.
  • Experience planning, conducting, and managing internal and external audits.
  • Strong understanding of document control, CAPA systems, training management, and quality records management.
  • Excellent organizational, communication, and project management skills.

Preferred Qualifications

  • ASQ Certified Quality Auditor (CQA) or similar certification.
  • AS9100 and/or ISO 13485 Lead Auditor certification.
  • Experience in Electronics Manufacturing Services (EMS).
  • Experience supporting Medical Device, Aerospace, and Defense industries.
  • Experience with eQMS platforms and compliance management systems.

Benefits

  • 401(k)
  • 401 (k) matching
  • Dental insurance
  • Health insurance
  • Vision insurance
  • Paid time off
XLR8 EMS logo

About XLR8 EMS

Sourced by ZipRecruiter

Industry

Electrical equipment, appliance, and component manufacturing

Company size

51 - 200 Employees

Headquarters location

San Clemente, CA, US

Year founded

2013

View All XLR8 EMS Jobs