1

Iso 11607 Jobs in Tennessee (NOW HIRING)

Quality Manager □ Lead Integrated Management System and ISO Recertification • Own the implementation, maintenance, and continuous improvement of ISO 9001, ISO 14001, and ISO 45001. • Develop ...

Quality Manager

Clarksville, TN · On-site

$110 - $140/hr

Lead Integrated Management System and ISO Recertification * Own the implementation, maintenance, and continuous improvement of ISO 9001, ISO 14001, and ISO 45001. * Develop and execute certification ...

ISO 9001 internal auditor training preferred. • Familiarity with root cause analysis tools (5 Whys, Fishbone, FMEA). • Experience using quality management systems (QMS) or related software. • ...

ISO 9001 internal auditor training preferred. • Familiarity with root cause analysis tools (5 Whys, Fishbone, FMEA). • Experience using quality management systems (QMS) or related software. • ...

ISO 9001 internal auditor training preferred. • Familiarity with root cause analysis tools (5 Whys, Fishbone, FMEA). • Experience using quality management systems (QMS) or related software. • ...

next page

Showing results 1-20

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 cities in Tennessee are hiring for Iso 11607 jobs?

Cities in Tennessee with the most Iso 11607 job openings:

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.

Quality Manager

Crucible Zinc

Clarksville, TN • On-site

Full-time

Re-posted 20 hours ago


Job description


                                                                   
Crucible Zinc is a growth-oriented metals manufacturing company focused on producing high-quality zinc products through safe, efficient, and environmentally responsible processes. We are committed to operational excellence, continuous improvement, and responsible stewardship of our people and resources. Our team-driven culture emphasizes safety, integrity, and collaboration while investing in innovation and employee development. At Crucible Zinc, employees play a vital role in supporting reliable operations and delivering value to our customers and communities.
THE ROLE:  Quality Manager
□ Lead Integrated Management System and ISO Recertification
• Own the implementation, maintenance, and continuous improvement of ISO 9001, ISO 14001, and ISO 45001.
• Develop and execute certification, recertification, and surveillance audit plans; serve as the primary contact for certification bodies and third-party auditors.
• Lead internal audits, management reviews, nonconformity closure, corrective action verification, and controlled document/record management.
□ Manage Site Quality Assurance and Quality Control
• Establish the Clarksville Smelter quality strategy, standards, inspection and test plans, critical-to-quality parameters, sampling, product release, traceability, and calibration controls.
• Monitor quality of raw materials, production processes, laboratories, intermediate and finished products, packaging, storage, and shipment.
• Lead investigations of product defects, process deviations, customer complaints, audit findings, and recurring nonconformities using RCA, FMEA, SPC, 5-Why, and CAPA.
□ Lead Quality for the Future Integrated Smelter Complex
• Serve as the overall quality lead from engineering, procurement, construction, and fabrication through mechanical completion, commissioning, start-up, ramp-up, and commercial operation.
• Develop the Project Quality Management Plan, quality governance, organization, ITP requirements, NCR/deviation/punch-list controls, turnover dossiers, and operational quality readiness.
• Review and approve contractor and supplier quality plans, inspections, FAT/SAT, material and welding records, as-built documentation, and commissioning test records.
□ Manage Supplier, Contractor, Audit, and Continuous Improvement Activities
• Establish risk-based supplier and contractor qualification, audit, surveillance, scorecard, and corrective action processes.
• Partner with Operations, Metallurgy, Maintenance, Engineering, Laboratory, Supply Chain, EHS, Commercial, and Project teams to resolve quality issues.
• Build and lead the quality organization, develop competencies and internal auditors, and report quality KPIs, major risks, and improvement priorities to management.
Qualifications/Experience
Bachelor's degree or above in Quality/Industrial or Metallurgical, Materials, Chemical, Mechanical Engineering, or a related technical discipline
• 10+ years of progressive experience in quality assurance, quality control, operations, metallurgy, engineering, or integrated management systems in a smelter, steel mill, refinery, metals processing plant, mining operation, chemical plant, or comparable heavy industry.
• 5+ years of experience in a quality leadership or management role.
• Proven experience implementing, maintaining, auditing, or leading certification/recertification activities for ISO 9001; practical working knowledge of ISO 14001 and ISO 45001.
• Experience managing certification, surveillance, customer, and internal audits, including timely closure and effectiveness verification of corrective actions.
• Strong knowledge of industrial process control, inspection and testing, product conformity, traceability, calibration, laboratory data integrity, and nonconforming product control.
• Demonstrated capability in root cause analysis, CAPA, document control, management review, risk-based thinking, and data-driven continuous improvement.
• Strong written and verbal English communication skills and the ability to coordinate with senior management, operations, engineers, contractors, suppliers, auditors, regulators, and customers.
• Ability to work in office, operating plant, laboratory, and active construction/commissioning environments and to travel as required.
• Direct quality management experience in zinc, lead, copper, nickel, steel, ferroalloy, foundry, refinery, or other ferrous/nonferrous metallurgical operations.
• Experience with pyrometallurgical or hydrometallurgical processes.
• Major capital project, EPC, construction, commissioning, or start-up quality leadership experience, preferably as Project Quality Manager or Owner’s Quality Representative.
• Experience with welding, structural steel, piping, pressure equipment, rotating equipment, electrical systems, instrumentation, refractory installation, and industrial construction inspection.
• Working knowledge of ASTM, ASME, AWS, API, AISC, IEC, NFPA, ISO/IEC 17025, or comparable industrial standards.
• CQE, CMQ/OE, ISO 9001/14001/45001 Lead Auditor, Six Sigma, Lean, or PMP certification.
• Experience with QMS, ERP, document management, and data visualization systems in a multicultural or global organization.
• The role is expected to transition from Clarksville site quality leadership to the overall quality head for the integrated smelter complex as the project advances.
• The position requires professional judgment and the authority to stop or hold production, shipment, construction, installation, testing, or commissioning when significant quality or compliance risk is identified.
• Final title, grade, reporting line, and team size may be calibrated based on candidate seniority and the integrated smelter project schedule.
• Extended hours may be required during certification audits, shutdowns, construction milestones, commissioning, and start-up.