ZipRecruiter

Log In

1

Iso 11607 Jobs in Tennessee (NOW HIRING)

Real Alloy

Quality Manager

Loudon, TN

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 ...

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 ...

Type One Energy Group, Inc.

Quality Engineer

Knoxville, TN · On-site

$80 - $100/hr

Plan, execute, and document risk-based approach to product development quality planning in alignment with company and ISO 9001 quality management system requirements. * Evaluate design execution and ...

Mirion Technologies

Senior Quality Engineer

Oak Ridge, TN · On-site

$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 · On-site

$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 ...

Adient

Quality Engineer

Pulaski, TN · On-site

$70K - $91K/yr

The Quality Engineer Complies with all BOS, ISO/TS-16949 and Customer Specific requirements. * Understands Plant/Customer KPI's and works with team to meet and exceed. * Participates as Layered ...

Phase2 Technology

Senior Quality Engineer

Oak Ridge, TN · On-site

$100 - $125/hr

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 ...

Teledyne FLIR LLC

Quality Engineer

Oak Ridge, TN · On-site

$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 ...

previous page

Showing results 41-60

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.

What are popular job titles related to Iso 11607 jobs in Tennessee?

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

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

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

What cities in Tennessee are hiring for Iso 11607 jobs?

Cities in Tennessee with the most Iso 11607 job openings:

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.

Senior Quality Engineer - Manufacturing - Base Salary to 108k/year - Johnson City, TN

AllSearch Professional Staffing

Johnson City, TN

$86K - $117K/yr

Full-time

Re-posted 28 days ago

Job description

Senior Quality Engineer - Manufacturing - Base Salary to 108k/year - Johnson City, TN

  • Our client, a global manufacturer of energy-efficient products and industrial equipment, is seeking an experienced Senior Quality Engineer to join their onsite team in Johnson City, TN.
  • The Senior Quality Engineer is responsible for leading a quality assurance team to ensure products meet or exceed customer expectations. This position supports manufacturing operations, partners with suppliers to resolve quality issues, leads ISO 9001 quality management system activities, drives continuous improvement initiatives, and mentors quality personnel in a high-volume manufacturing environment.

Responsibilities:

  • Supervise and coordinate the work of the quality department.
  • Lead quality assurance activities supporting manufacturing operations and production processes.
  • Utilize statistical analysis tools and quality methodologies to evaluate supplier performance and manufacturing processes.
  • Conduct root cause analysis of supplier and manufacturing defects using structured problem-solving methodologies and implement corrective and preventive actions (CAPA) to improve product quality and reduce process variation.
  • Analyze manufacturing and quality data using computerized data acquisition systems and prepare reports for management.
  • Review quality analysis results and recommend improvements to quality systems, procedures, and manufacturing processes.
  • Determine, complete, and review Supplier PPAP documentation.
  • Serve as the primary liaison with suppliers to resolve supplier quality issues and ensure timely corrective actions.
  • Prepare and analyze reports on rejected, nonconforming, and defective products.
  • Lead quality assurance projects and cross-functional quality improvement initiatives.
  • Conduct performance evaluations for quality technicians and engineers and provide hiring recommendations as needed.
  • Report significant or recurring quality issues to the Quality Assurance Manager.
  • Perform quality analysis for specific products, manufacturing processes, or production lines as assigned.
  • Support ISO 9001 compliance, internal audits, supplier quality initiatives, and continuous improvement efforts.

Qualifications:

  • Bachelor's degree in Engineering.
  • 5+ years of experience in manufacturing, quality engineering, and technical leadership or supervisory roles.
  • Experience within machinery manufacturing.
  • Experience supporting water heating equipment, heat pumps, industrial equipment, or similar manufactured products.
  • Experience leading supplier quality activities, including PPAP reviews and supplier corrective actions.
  • Experience performing root cause analysis, statistical process analysis, corrective and preventive actions (CAPA), and continuous improvement initiatives.
  • Working knowledge of ISO 9001 quality management systems.
  • Strong communication, leadership, analytical, and problem-solving skills.

Compensation:

  • Base salary in the 100k - 108k/year range
  • Benefits
  • Bonus Opportunity
  • Relocation Coverage
  • Hybrid Work Opportunity

#INDALL