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Iso 11607 Jobs in Virginia (NOW HIRING)

Aurora Lifesciences

Senior Quality Engineer

Manassas, VA · On-site

$95 - $125/hr

Leading and supporting internal audits against ISO 13485 and ensuring actions are driven through to completion. * Supporting customer, supplier and regulatory audits. * Leading quality improvement ...

Posted today

Vangrace

Quality Engineer

Danville, VA · On-site

$70 - $90/hr

The Quality Engineer needs IATF 16949 ISO 9001 and/or ISO 14001 background and strong analytical and problem-solving skills, experience with manufacturing quality systems, and drive continuous ...

advansix

Quality Control Engineer

Chester, VA

$69K - $103K/yr

Conduct audits of processes, procedures, and systems to identify improvement opportunities and ensure compliance with quality standards (e.g., ISO 9001, GMP). * Support training efforts and ...

advansix

Quality Control Engineer

Chester, VA · On-site

$69K - $103K/yr

Conduct audits of processes, procedures, and systems to identify improvement opportunities and ensure compliance with quality standards (e.g., ISO 9001, GMP). * Support training efforts and ...

LifeNet Health

Quality Engineer I

Virginia Beach, VA · On-site

$68K - $88K/yr

Ensure compliance with applicable regulatory and quality system requirements including 21 CFR Part 820, ISO 13485, and ISO 14971 across product and process activities. * Provide Quality Engineering ...

LifeNet Health

Quality Engineer I

Virginia Beach, VA

$64K - $83K/yr

Ensure compliance with applicable regulatory and quality system requirements including 21 CFR Part 820, ISO 13485, and ISO 14971 across product and process activities. * Provide Quality Engineering ...

LifeNet Health

Quality Engineer I

Virginia Beach, VA · On-site

$68K - $88K/yr

Ensure compliance with applicable regulatory and quality system requirements including 21 CFR Part 820, ISO 13485, and ISO 14971 across product and process activities. * Provide Quality Engineering ...

LifeNet Health

Quality Engineer I

Virginia Beach, VA · On-site

$75.84 - $101.12/hr

Ensure compliance with applicable regulatory and quality system requirements including 21 CFR Part 820, ISO 13485, and ISO 14971 across product and process activities. * Provide Quality Engineering ...

LifeNet Health

Quality Engineer I

Virginia Beach, VA

$64K - $83K/yr

Ensure compliance with applicable regulatory and quality system requirements including 21 CFR Part 820, ISO 13485, and ISO 14971 across product and process activities. * Provide Quality Engineering ...

Total Plastic Solutions

Quality Engineer

Lynchburg, VA · On-site

$70K - $90K/yr

Medical Components ISO 13485; Aerospace AS9100; Consumer Products ISO 9001. This role must comply with all TPS policies, SOP's, cGMP and Management System requirements. Job Duties: * Quality Control ...

Fullscope

Quality Assurance Specialist

Chesapeake, VA · On-site

CMMI, ISO and certifications as determined by ESN leadership; process improvement; and reporting. Supports Corporate Growth objectives through measures and metrics, proposal support, strategic ...

Jobtailor

Quality Engineer

Richmond, VA · On-site

$95 - $130/hr

Working knowledge of Quality Management Systems and ISO-based standards * Ability to read and interpret engineering drawings, blueprints, and schematics * Experience leading continuous improvement ...

Fullscope

Quality Assurance Specialist

Chesapeake, VA · On-site

CMMI, ISO and certifications as determined by ESN leadership; process improvement; and reporting. Supports Corporate Growth objectives through measures and metrics, proposal support, strategic ...

Total Plastic Solutions

Quality Engineer

Lynchburg, VA · On-site

$65 - $95/hr

Medical Components ISO 13485; Aerospace AS9100; Consumer Products ISO 9001. This role must comply with all TPS policies, SOPs, cGMP and Management System requirements. Responsibilities * Quality ...

Hillenbrand

Quality manager

Wytheville, VA · On-site

ManageCoperion'scompliance with ISO standards * Develop,execute,andmaintainstrategies to improve equipment performance and reliability, minimize qualitycostsand increase customer satisfaction

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Showing results 1-20

All JobsIso 11607 JobsIso 11607 Jobs in Virginia

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 Virginia?

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

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

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

Iso 11607 jobs near you

Quality Engineer - Battery Separator Manufacturing (IATF 16949 / ISO 9001)

Danville, VA

Great Bay Staffing Group
Recruiting and Staffing Services • 1 - 10 employees
Learn more about Great Bay Staffing Groupexternal

$71K - $92K/yr

Full-time

Posted 29 days ago

Job description

$90,000–$110,000 + 15% Bonus Potential

Danville, Virginia

The Opportunity

This is a chance to help stand up quality systems at a new lithium-ion battery separator plant from the ground up. Plant startups don't come around often, and they give a Quality Engineer real influence over how processes, controls, and standards get built — not just maintained.

You'll work directly with Operations, Engineering, R&D, Supply Chain, and Production to make sure products meet customer requirements and regulatory standards from day one.

Why You'll Love This Role
  • Ground-floor involvement in a plant startup, with the growth and visibility that comes with it
  • Ownership of assigned projects, investigations, and quality initiatives — not just a supporting role
  • Direct exposure to lithium-ion battery separator manufacturing, a specialized and growing segment of the battery supply chain
  • Work across a full quality toolkit: SPC, PFMEA, control plans, 5 Why analysis, fishbone diagrams, and CAPA processes
  • Relocation assistance provided
  • Base salary of $90,000–$110,000 plus 15% bonus potential
Your Day-to-Day
  • Monitor manufacturing processes and product quality performance
  • Analyze quality data and trends to identify improvement opportunities
  • Investigate product defects, process deviations, and customer complaints
  • Lead or support root cause analysis and corrective action implementation
  • Participate in process validation, qualification, and product testing
  • Drive Lean Manufacturing and continuous improvement projects targeting scrap reduction and process variation
  • Support internal audits, external audits, and customer quality assessments
  • Maintain quality documentation, procedures, and work instructions
What We're Looking For
  • Bachelor's degree in Engineering, Quality, Manufacturing, Materials Science, or related field
  • 3–5 years of quality engineering experience in battery manufacturing, coatings, plastics, chemical processing, automotive, or industrial manufacturing
  • Working knowledge of IATF 16949, ISO 9001, and/or ISO 14001 quality systems
  • Experience with root cause analysis and process improvement methodologies
  • Proficiency with SPC, PFMEA, control plans, and statistical analysis tools
  • ASQ certification or equivalent preferred
  • Strong analytical, technical, and problem-solving skills
  • Ability to manage multiple priorities in a manufacturing environment
Why Candidates Say Yes
  • Plant startup — the opportunity to shape quality systems rather than inherit someone else's
  • Specialized, high-growth industry: lithium-ion battery separators
  • Clear ownership over projects and initiatives from day one
  • Relocation assistance included
Ready to Apply?

If you're ready to bring your quality engineering expertise to a plant startup in the battery separator space, we'd like to hear from you.

Great Bay Staffing represents candidates with complete confidentiality. Your resume will never be shared with a client without your knowledge and approval.