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Iso 11607 Jobs in Tennessee (NOW HIRING)

Smith & Nephew

Packaging Process Engineer

Memphis, TN · On-site

Validate packaging processes in line with ISO 11607 requirements * Troubleshoot and resolve operational process and equipment issues * Support NC and CAPA activities, including investigations and ...

Crucible Zinc

Quality Manager

Clarksville, TN

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 ...

BWXT

Quality Assurance Specialist

Oak Ridge, TN

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. • ...

BWXT

Quality Assurance Specialist

Oak Ridge, TN

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. • ...

BWXT

Quality Assurance Specialist

Oak Ridge, TN · On-site

$70K - $103K/yr

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. • ...

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 ...

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Showing results 1-20

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.
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.

Packaging Process Engineer

Smith & Nephew

Memphis, TN • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 9 days ago

Smith & Nephew rating

8.1

Company rating: 8.1 out of 10

Based on 41 frontline employees who took The Breakroom Quiz

117th of 538 rated manufacturers

Job description

Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living.
Join a high impact Packaging Process Engineering team where your work will directly support the delivery of innovative orthopedic medical devices. Based in Memphis, TN, this is an exciting opportunity to contribute to new product launches, drive process improvements, and play a key role in delivering quality and efficiency in a collaborative and forward-thinking environment.
What will you be doing?
  • Lead and coordinate packaging process engineering projects from concept through implementation
  • Develop and optimize packaging processes including sealing and forming equipment, vision systems, labeling and barcoding, and electronic data systems
  • Validate packaging processes in line with ISO 11607 requirements
  • Troubleshoot and resolve operational process and equipment issues
  • Support NC and CAPA activities, including investigations and continuous improvement actions
  • Contribute to equipment, product, and supplier transfers as well as design and material changes
  • Create and maintain process documentation within change management systems

What will you need to be successful?
Education:
  • Bachelor's degree in Packaging Engineering, Mechanical Engineering, Industrial Engineering, or a related technical discipline

Experience:
  • 0 to 2 years of relevant experience, including internships or early career experience in the medical device or healthcare industry

Competences:
  • Strong communication and technical writing skills

You. Unlimited.
We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.
  • Inclusion and Belonging- Committed to Welcoming, Celebrating and Thriving on Inclusion and Belonging, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/).
  • Your Future: 401k Matching Program, 401k Plus Program, Discounted Stock Purchase Plan, Tuition Reimbursement
  • Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
  • Your Wellbeing: Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually), Employee Assistance Program, Parental Leave, Fertility and Adoption Assistance Program
  • Flexibility: Hybrid Work Model (For most professional roles)
  • Training: Hands-On, Team-Customized, Mentorship
  • Extra Perks: Discounts on fitness clubs, travel and more!

Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability.
Stay connected by joining our Talent Community.
We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.
Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at S+N.
Explore our website and learn more about our mission, our team, and the opportunities we offer.

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