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Iso 11607 Jobs in Connecticut (NOW HIRING)

FuelCell Energy

Manager, Corporate Quality

Torrington, CT · On-site

$80 - $100/hr

Serve as the primary owner and internal subject matter expert for the company's ISO 9001‑registered QMS, ensuring ongoing compliance and audit readiness. * Oversee maintenance and improvement of ...

W3Global Inc.

Senior Quality Engineer

Avon, CT · On-site

$90K - $100K/yr

Working knowledge of ISO 9001, ISO 13485, and IATF 16949 standards. * Strong skills in applied statistics, MSA, reliability, and project coordination. * Proficiency with quality-related software ...

Element Solutions Inc

Quality Engineer

West Haven, CT

$69K - $90K/yr

Working knowledge of ISO 9001 and familiarity with IATF 16949, ISO 14001, or ISO 45001 standards. * Familiarity with lab software, Microsoft Office Suite, and comfortable learning tools such as ...

Element Solutions Inc

Quality Engineer

West Haven, CT · On-site

$81 - $122/hr

Working knowledge of ISO 9001 and familiarity with IATF 16949, ISO 14001, or ISO 45001 standards. * Familiarity with lab software, Microsoft Office Suite, and comfortable learning tools such as ...

Element Solutions Inc

Quality Engineer

West Haven, CT

$69K - $90K/yr

Working knowledge of ISO 9001 and familiarity with IATF 16949, ISO 14001, or ISO 45001 standards. * Familiarity with lab software, Microsoft Office Suite, and comfortable learning tools such as ...

Element Solutions

Quality Engineer

West Haven, CT · On-site

$69K - $90K/yr

Working knowledge of ISO 9001 and familiarity with IATF 16949, ISO 14001, or ISO 45001 standards. * Familiarity with lab software, Microsoft Office Suite, and comfortable learning tools such as ...

AVS Bio

AVS Bio Senior QA Scientist

Storrs, CT · On-site

$76.50 - $93.50/hr

Job Overview Design, implement, and maintain comprehensive Quality Management Systems (QMS) in accordance with applicable regulatory standards (ISO 9001, ISO 13485, 21 CFR Part 820, or industry ...

DOOSAN

Quality Inspector

South Windsor, CT · On-site

Knowledge of ISO Standards - ISO 9001 & ISO 14001 are a plus. Knowledge & Skill: * * Knowledge of machine shop and manufacturing related practices, processes, methods and techniques. * Work from ...

Doosan

Quality Inspector

South Windsor, CT · On-site

Knowledge of ISO Standards - ISO 9001 & ISO 14001 are a plus. Knowledge & Skill: * * Knowledge of machine shop and manufacturing related practices, processes, methods and techniques. * Work from ...

Wieland

Sr Quality Engineer

Waterbury, CT · On-site

$100K - $115K/yr

Perform internal and process audits as required by our ISO 9001 certification * Help organize and manage management review meetings for quality management system * Assists in all quality audit ...

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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 Connecticut?

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

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

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

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Iso 11607 jobs near you

Sr. Packaging Engineer

Jobs for Humanity

North Haven, CT • On-site

Full-time

Posted 11 days ago

Job description

Company Description

Centillion Infotech LLC has served clients since 2017 from our US headquarters in Coppell, Texas, We work with organizations across the United States the technology capability to change a system and the workforce capability to keep it running.

That combination is deliberate. Modernization programs stall when strategy, engineering and staffing sit with three parties who each own a fragment of the outcome.

Job Description

Job Summary

We are seeking a Packaging Engineer with experience in Medical Device packaging, packaging equipment, and packaging validation. The ideal candidate will support packaging design, process validation, equipment qualification, and manufacturing projects while ensuring compliance with FDA and ISO standards.

Required Skills

        Bachelor's degree in Packaging Engineering, Mechanical Engineering, Manufacturing Engineering, or a related field.

        4+ years of Packaging/Manufacturing Engineering experience.

        Experience with medical packaging materials and high-volume packaging equipment (FFS, Bar Sealer, Alloyd).

        Hands-on experience with IQ, OQ, PQ and Process Validation.

        Knowledge of the Process Validation Lifecycle (Process Characterization, OQ, PQ).

        Experience preparing validation protocols, reports, SOPs, and controlled documentation.

        Strong troubleshooting, Root Cause Analysis, and project management skills.

        Experience working with cross-functional teams in Manufacturing, Quality, and Regulatory.

Qualifications

Preferred Skills

        Packaging system design and validation per ISO 11607-1 & ISO 11607-2.

        Knowledge of ASTM and ISTA packaging standards.

        Experience with DOE (Minitab).

        Computer System Validation (CSV).

        Medical Device Change Control.

        Custom equipment validation.

        Knowledge of FDA 21 CFR Part 820, GMP, and Medical Device Quality Systems.

Key Responsibilities

        Design and develop medical device packaging systems and manufacturing processes.

        Lead IQ, OQ, PQ, packaging validation, and equipment qualification activities.

        Develop and review validation protocols, reports, SOPs, and manufacturing documentation.

        Support packaging equipment installation, troubleshooting, and process improvements.

        Ensure compliance with FDA, ISO, GMP, and regulatory requirements.

        Manage packaging projects, timelines, and cross-functional deliverables.

        This role is ideal for a Packaging Engineer with strong experience in medical device packaging, packaging equipment, validation (IQ/OQ/PQ), ISO 11607, and project management.

Additional Information

Adam AB

Centillion Infotech LLC

Phone: 469.770.0087

Web: www.centillioninfotech.com

Email:[email protected]

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