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Iso 11607 Jobs in Tennessee (NOW HIRING)

Printpack

Quality Manager

Jackson, TN · On-site

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 ...

Printpack

Quality Manager

Jackson, TN

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 ...

gleason

Supplier Quality Engineer

Gleason, TN

Plan and conduct ISO quality systems audits of key suppliers as well as new suppliers. * Support new product development and all sourcing initiatives to qualify potential suppliers including ...

gleason

Supplier Quality Engineer

Gleason, TN

Plan and conduct ISO quality systems audits of key suppliers as well as new suppliers. * Support new product development and all sourcing initiatives to qualify potential suppliers including ...

ADPma, LLC

Quality Inspector

Piney Flats, TN · On-site

... ISO 9001. The ideal candidate has strong inspection experience, excellent problem-solving skills, and a commitment to quality and safety.Key Responsibilities * Perform first article, in-process, and ...

ADPma, LLC

Quality Inspector

Piney Flats, TN · On-site

... and ISO 9001. The ideal candidate has strong inspection experience, excellent problem‑solving skills, and a commitment to quality and safety. Key Responsibilities * Perform first article ...

Real Alloy

Quality Manager

Loudon, TN · On-site

The role ensures ISO 9001 compliance, leads corrective actions, and partners with plant leadership to improve key operational metrics. We are looking for a dynamic leader that can have a positive ...

ATCDT Corp.

Quality Manager

Knoxville, TN · On-site

$85 - $115/hr

Responsible for development and adherence to the policies, procedures, and instructions of the Quality, MMOG, and ISO 14001 systems. * Committed to a safe and accident-free work environment.

ATC DRIVETRAIN LLC

Quality Manager

Knoxville, TN · On-site

Responsible for development and adherence to the policies, procedures, and instructions of the Quality, MMOG, and ISO 14001 systems. * Committed to a safe and accident-free work environment.

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Showing results 21-40

All JobsIso 11607 JobsIso 11607 Jobs in Tennessee

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.

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

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Iso 11607 jobs near you
Infographic showing various Iso 11607 job openings in Tennessee as of August 2026, with employment types broken down into 87% Full Time, 5% Part Time, 6% Contract, and 2% Nights. Highlights an 89% Physical, 5% Hybrid, and 6% Remote job distribution.

HSQ Compliance Manager

PERMA FIX ENVIRONMENTAL SERVICES INC

Oak Ridge, TN • On-site

$80K - $110K/yr

Full-time

Posted 26 days ago

Job description

Description

EXEMPT. This position will assist the Vice President, EHSQ (VP, EHSQ) in the development, implementation, and management of Safety, Health, and Quality programs. The CM will ensure HSQ programs and associated activities satisfy referenced regulations and standards. The position will be a champion for safety compliance and continuous improvement in performance assurance.


Duties

Ensure the corporate Quality Management System (QMS) and QA procedures comply with NQA-1 and ISO 9001 requirements.

Work with Facility Quality Assurance Managers (QAM) to ensure QA manuals comply with NQA-1 and ISO 9001 requirements.

Work with the laboratory Quality Assurance Representative (QAR) to ensure compliance with ISO 9001 and 17025 requirements.

Work with the facility QAM and QAR to ensure adequate preparation for external audits and surveillance activities.


Health and Safety

Support the Corporate HS Manager (CHSM) by:

Reviewing HS program and procedures to ensure compliance with OSHA regulations.

Reviewing incident reports to ensure appropriate cause analysis and actions to prevent recurrence.

Reviewing HS training to ensure consistency throughout facilities and projects


Common QA/HS Responsibilities

Maintain a compliant corporate document control and record management system.

Support development, preparation, and maintenance of QA/HS procedures and forms.

Perform compliance audits to identify gaps, vulnerabilities, or opportunities for improvement.

Support investigations of non-compliant conditions or incidents and ensure proper cause analysis.

Support development, implementation, and tracking of corrective and preventive actions to address non-compliant conditions.

Maintain EHSQ performance metrics and prepare presentation slides for senior management.

Serve as the backup administrator for the EHSQ software system.

Requirements

Four-year degree or equivalent experience.

3-5 years working experience in QA/HS.

Capable of attaining Associate Safety Professional certification within 1 year.

Experience working with Department of Energy, DOD, or government projects.

Experience working under an NQA-1/ISO 9001 Quality Assurance Program.

Proficient in Microsoft Word, Excel, PowerPoint, Visio, and Access.


Office and construction field environment; some light lifting, bending, and reaching necessary. 15% Travel or as necessary.

Apply