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Iso 11607 Jobs in Ohio (NOW HIRING)

Auto-Valve, Inc.

Quality Manager

Dayton, OH · On-site

$100K - $130K/yr

ISO 9001 (AS9100 experience preferred) * Customer-specific quality requirements * Applicable FAR clauses * Coordinate responses to regulatory findings and customer audits. * Develop corrective action ...

Actalent

Quality Engineer

Delaware, OH

$85K - $120K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Lead the development, implementation, and maintenance of an ISO 9001-compliant Quality Management System (QMS). * Conduct QMS gap assessments and create implementation roadmaps for certification ...

Robin Industries, Inc

Quality Manager

Millersburg, OH · On-site

Knowledgeable in ISO and Automotive (ISO/TS 16949), ISO 13485, ISO 9001 and ISO 14001 standards. Knowledge of FDA 21 CFR 820 would be a plus. Proficiency in Microsoft Word, Excel, PowerPoint Skilled ...

Auto-Valve, Inc

Quality Manager

Dayton, OH · On-site

$100K - $130K/yr

ISO 9001 (AS9100 experience preferred) * Customer-specific quality requirements * Applicable FAR clauses * Coordinate responses to regulatory findings and customer audits. * Develop corrective action ...

Robin Industries, Inc.

Quality Manager

Millersburg, OH · On-site

Knowledgeable in ISO and Automotive (ISO/TS 16949), ISO 13485, ISO 9001 and ISO 14001 standards. Knowledge of FDA 21 CFR 820 would be a plus. Proficiency in Microsoft Word, Excel, PowerPoint Skilled ...

Research Group

Quality Manager

Mentor, OH · On-site

Serve as Management Representative for ISO and certification audits, leading all internal and external audits, including ISO, FDA, and customer audits. * Analyze quality data and trends to identify ...

PPS-HPS

Quality Inspector

Willoughby, OH

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

You will utilize your keen eye for detail and expertise in quality control to perform inspections and tests on products, ensuring compliance with industry regulations such as ISO:9001 and AS9100 ...

Research Group

Quality Manager

Mentor, OH · On-site

Serve as Management Representative for ISO and certification audits, leading all internal and external audits, including ISO, FDA, and customer audits. * Analyze quality data and trends to identify ...

Research Group

Quality Manager

Mentor, OH · On-site

Serve as Management Representative for ISO and certification audits, leading all internal and external audits, including ISO, FDA, and customer audits. * Analyze quality data and trends to identify ...

Terry Young & Associates

Be Seen First

Quality Engineer - Manufacturing

Akron, OH · On-site

$95K - $100K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

QMS support and maintain ISO 9001 and maintain quality procedures and instructions. Corrective Action leading root cause investigations using 8D, 5-Why, Fishbone, AD to drive containment, corrective ...

New

Thermo Fisher Scientific

Quality Engineer III

Marietta, OH

$56K - $73K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Ensure compliance with applicable FDA regulations, GMP requirements, and ISO quality standards. * Develop, review, and improve quality documentation, procedures, and processes. * Monitor quality ...

Thermo Fisher Scientific

Quality Engineer III

Marietta, OH · On-site

$56K - $73K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Ensure compliance with applicable FDA regulations, GMP requirements, and ISO quality standards. * Develop, review, and improve quality documentation, procedures, and processes. * Monitor quality ...

Thermo Fisher Scientific

Quality Engineer III

Marietta, OH · On-site

$56K - $73K/yr

  • Medical

  • Dental

  • Vision

  • Retirement

  • PTO

Ensure compliance with applicable FDA regulations, GMP requirements, and ISO quality standards. * Develop, review, and improve quality documentation, procedures, and processes. * Monitor quality ...

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Showing results 21-40

All JobsIso 11607 JobsIso 11607 Jobs in Ohio

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 Ohio?

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

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

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

What cities in Ohio are hiring for Iso 11607 jobs?

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Iso 11607 jobs near you

Quality and Food Safety Manager

M&M Industries

Lordstown, OH • On-site

$85 - $120/hr

Other

Posted yesterday

New

Job description

Overview

M&M Industries is a U.S.-based manufacturer of plastic pails and packaging solutions. We operate in a fast-paced manufacturing environment where quality, food safety, compliance, and continuous improvement are critical to meeting customer and regulatory requirements.

The Quality Assurance & Food Safety Manager supports the Director of Quality Assurance to ensure daily quality and food safety goals are met. This role provides guidance, training, support, and direction to direct reports to ensure desired results are achieved. The Quality Assurance & Food Safety Manager must be a results-driven leader with a passion for implementing and sustaining improvements, with the ability to think strategically, solve problems, lead team members, and drive quality. This role acts as Management Representative for regulatory compliance, including ISO 9001, FSSC 22000, and IMS, and is responsible for maintaining the food safety program utilizing HACCP/GMP methods.

Responsibilities
  • Perform QC test data analysis
  • Manage responsibilities including scheduling Quality Lab Technicians, conducting routine employee evaluations by due dates, and providing training and support for team development
  • Organize and attend customer visits as needed to complete customer corrective action investigations
  • Supervise daily activities of the appraisal function including working safely, reviewing QC documentation from the previous 24 hours, dispositioning nonconformance reports, performing scrap analysis, and troubleshooting quality-related issues on the production floor
  • Generate weekly and monthly reports on quality-related KPIs
  • Conduct GMP and UN HazMat training as required
  • Plan own work, identify obstacles, and address training needs
  • Conduct product or material testing using metrology equipment
  • Perform data entry and reporting of test results including graphing and statistical analysis
  • Maintain all documents
  • Participate in meetings requiring Quality representation
  • Communicate all Quality findings to the Director of Quality Assurance
  • Perform internal audits and maintain audit findings at the plant level
  • Collaborate with production and processing teams to identify quality improvement initiatives
Qualifications Knowledge, Skills & Abilities
  • CMM operation and programming
  • Understanding of injection molding processes
  • Knowledge of ISO 9001:2015 Quality Standard
  • Knowledge of food safety standards and guidance programs such as GFSI, HACCP, GMP, SQF, ISO 22000, and FSSC 22000
  • Proficient in presenting test data reports to colleagues and customers
  • Proficient in Microsoft Word and Excel
  • Skill in writing procedures
  • Excellent verbal and written communication skills
Education
  • Minimum four (4) year degree or equivalent quality experience required
Experience
  • Minimum three (3) years of experience in a senior quality role required, preferably in a food-grade manufacturing environment
  • Experience implementing and maintaining ISO 9001:2015 Quality Standard required, minimum three (3) years
  • Experience implementing and maintaining food safety quality programs such as GFSI and/or FSSC required, minimum two (2) years
  • Experience with Lean Manufacturing concepts preferred
Licenses & Certifications
  • Certified internal or lead auditor for ISO 9001 and/or other regulatory standards required
  • HACCP certification preferred
Physical Requirements
  • Ability to perform some lifting, extended standing, and walking
  • Ability to work in a manufacturing environment that may be hot or cold
  • Ability to wear required PPE at all times (safety glasses, safety shoes, etc.)
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