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Iso 11607 Jobs in Tennessee (NOW HIRING)

gleason

Supplier Quality Engineer

Gleason, TN · On-site

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 · On-site

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 ...

Kelvion Products Inc

Quality Engineer

Knoxville, TN · On-site

$66K - $85K/yr

Experience in conducting internal audits and assessments per ISO 9001 and ASME Sect. VIII Div. I * Attention to Detail: Ensuring accuracy in all aspects of quality control, including data collection ...

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 ...

TE Connectivity

QMS SPECIALIST III

Tullahoma, TN · On-site

$92K - $116K/yr

Job Overview We are seeking a Senior Quality Analyst / QMS Auditor to support and continuously improve our IATF 16949 and ISO 9001 -compliant Quality Management System . This role plays a key part in ...

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 ...

Autocam Medical

Quality Engineer

Murfreesboro, TN · On-site

$64K - $83K/yr

... ISO 13485 and FDA QSR requirements. • May ensure that quality reporting (e.g. incoming and in-process quality trends; returns analysis, categorization and corrective action activity, etc.) is ...

Mirion Technologies

Senior Quality Engineer

Oak Ridge, TN

$76K - $104K/yr

Demonstrate knowledge of ISO 9001:2015, 45001:2018, and 17025:2017 standards; ensure QMS compliance; conduct internal audits and corrective actions. * Corporate/Site: Complete required compliance ...

Integrated Resources INC

Quality Manager

Memphis, TN · On-site

The role is responsible for the ensuring the effectiveness of the QMS and monitoring compliance associated with CLIA, CAP, State regulations, ISO 9001, ISO 17025 and the QSR. Responsibilities:

Teledyne

Quality Engineer

Oak Ridge, TN

$68K - $88K/yr

Maintain and improve a QMS aligned to ISO 9001:2015 * Develop inspection plans for manufacturing and assembly processes * Analyse yield, scrap, rework, and defect trends to drive improvements * Lead ...

Bharat Forge America

Quality Engineer

Surgoinsville, TN · On-site

$57K - $74K/yr

Ensure compliance with IATF 16949, ISO, customer-specific requirements, and internal quality standards. · Support and maintain quality documentation including procedures, work instructions, and ...

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Showing results 21-40

All JobsIso 11607 JobsIso 11607 Jobs in Tennessee

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
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.

Supplier Quality Engineer

gleason

Gleason, TN • On-site

Full-time

Re-posted 27 days ago

Job description

Position Summary:

This position designs, develops and executes domestic and international supplier quality requirements. 

Job Responsibilities:

  • Assist in the development of worldwide supply chain strategies including the standardization of quality policies and procedures pertaining to 3rd party sourcing. 
  • Collaborate with local management, supply chain, and technical resources to improve supplier quality performance via data-driven root cause & corrective action processes. 
  • 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; supplier evaluation, selection and qualification for new materials, subassemblies, assemblies and services.
  • Containment, Root Cause, Corrective Action Oversite and Approval
  • Supplier qualification, selection and auditing
  • Data mining, scorecarding, and communication of performance by supplier
  • Management of Supplier OSARs (containment, root cause, corrective action, verification)
  • Management of Material Review Board (MRB)
  • Execute First Article Certification / Inspection protocol

 

Qualifications (Knowledge, Skills & Abilities):

  • Understanding of GD&T (or familiarity with ANSI/DIN/ASME standards)
  • Machining Methods knowledge (tool related, automotive, or aircraft)
  • Experience working in or with a metal working/manufacturing environment with alloy steels, Ferrous castings, and forgings
  • Strong knowledge of problem solving tools (5-Why, FMEA, SIPOC)
  • Experience implementing formal corrective action
  • Strong data mining / data analysis skills
  • Excellent communication skills (verbal and written)
  • ISO Supplier Auditing

 

Preferred Education/Training/Experience:

  • Associate’s Degree Engineering background (ME, EE, IE) required, Bachelor’s Preferred.
  • 3-5 years’ experience in Engineering Environment.
  • Supplier Quality related experience

Professional Certificates, Licenses or Registrations:

  • ISO Auditor certification preferred

Computer Skills:

  • Microsoft Office (Word, Excel, PowerPoint)
  • Outlook
  • Internet
  • SAP Modules: Quality Module

Travel Requirements:

  • Up to 25%

Apply