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Iso 11607 Jobs in Virginia (NOW HIRING)

AdvanSix

Quality Control Engineer

Chester, VA · On-site

$69K - $103K/yr

Familiarity with quality system standards such as ISO 9001, GMP, or ISO 17025. * Excellent communication and organizational skills, with the ability to handle multiple tasks and interface across ...

Hitachi

Lead Quality Engineer

South Boston, VA

Ensure compliance with ISO 9001, CSA N299.3, and applicable ASME, ASTM, IEC, and IEEE standards. * Support change control, document control, design reviews, and new product introductions.

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Showing results 21-40

All JobsIso 11607 JobsIso 11607 Jobs in Virginia

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 Virginia? For Iso 11607 jobs in Virginia, the most frequently searched job titles are:
What job categories do people searching Iso 11607 jobs in Virginia look for? The top searched job categories for Iso 11607 jobs in Virginia are:
Iso 11607 jobs near you

Quality Manager - Stuarts Draft

NIBCO

Stuarts Draft, VA • On-site

Full-time

Posted 7 days ago

NIBCO rating

7.5

Company rating: 7.5 out of 10

Based on 18 frontline employees who took The Breakroom Quiz

Job description

POSITION INFO:
POSITION TITLE: Quality Assurance Manager
DEPARTMENT/CATEGORY: Manufacturing
JOB TYPE: Salary Level
REPORTS TO: Plant Manager
LOCATION: Stuarts Draft, VA
POSITION SUMMARY:
This position is primarily responsible for establishing, enhancing, and maintaining a quality process system that will ensure, when adhered to, the manufacture of products and services provided to all customers will conform to agreed upon standards and requirements.
RESPONSIBILITIES:
• Develop facility quality procedures and major quality objectives that support the corporate quality policy.
• Design & monitor the system of product quality rating, audits, surveillance and summarized reports needed to provide quality assurance management.
• Maintain the facility Quality Assurance procedures including Standard Operating Procedures and all ISO procedures/processes/audits.
• Collaborate with product development, engineering and manufacturing teams to address quality issues.
• Conduct internal audits for ISO compliance. Train auditors as required.
• Ensure compliance with industry regulations and standards, NIBCO safety, OSHA, environmental, and quality programs.
• Work with suppliers in the resolution of quality problems; communicate standards of performance and quality requirements.
• Utilize analytical tools to analyze processes, identify trends and solve problems. Communicate effectively the results of data analysis with appropriate individuals, including customers.
• Provide leadership, training, and development opportunities to Quality team to enhance team skills and performance.
EXPERIENCE:
Quality and manufacturing experience required
EDUCATION:
Bachelors degree required
TRAINING AND SKILLS:
• Strong Computer Skills including Microsoft Office (Excel, Word, Outlook). SAP experience preferred.
• Leadership
• Verbal and written communication
• Process Management
• Teamwork/Cooperation
• Customer Focus
• Problem Solving
• Planning and Organizing
• Information Monitoring
• Quality/Attention to Detail

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