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Iso 11607 Jobs in Ohio (NOW HIRING)

Quality Manager

Monroe, OH · On-site

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

In this high-impact role, you will ensure compliance with FDA, ISO 9001, ISO 13485, CE, and other applicable standards, while partnering with Manufacturing, Engineering, Supply Chain, and Regulatory ...

Engineer- Quality III USA

Perrysburg, OH

$67K - $87K/yr

Manages product and process quality systems according to company policy and ISO Standards, facilitating internal and external customer satisfaction. Analyzes metric, audit, inspection and ...

Engineer- Quality III USA

Perrysburg, OH · On-site

$67K - $87K/yr

Manages product and process quality systems according to company policy and ISO Standards, facilitating internal and external customer satisfaction. Analyzes metric, audit, inspection and ...

Quality Engineer

Delaware, OH · On-site

$68K - $88K/yr

Develop, implement, and maintain an ISO 9001-compliant Quality Management System (QMS), including the quality manual/structure, process interactions, and required documented information. * Lead QMS ...

Quality Engineer

Delaware, OH

$68K - $88K/yr

Develop, implement, and maintain an ISO 9001-compliant Quality Management System (QMS), including the quality manual/structure, process interactions, and required documented information. * Lead QMS ...

Quality Engineer

Delaware, OH

$68K - $88K/yr

Develop, implement, and maintain an ISO 9001-compliant Quality Management System (QMS), including the quality manual/structure, process interactions, and required documented information. * Lead QMS ...

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Quality Manager

Stow, OH · On-site

$75K - $85K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Maintain an ISO/AS based quality system that ensures customer requirements are adhered to on a consistent basis. Assist in developing plans for providing employees with the necessary training to ...

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

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 ...

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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 Ohio?

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

What cities in Ohio are hiring for Iso 11607 jobs?

Cities in Ohio with the most Iso 11607 job openings:

Package Development Engineering

LanceSoft Inc

Cincinnati, OH

Contractor

Re-posted 10 days ago


Job description

Company Description

Medical Device/ Pharmaceutical Company.

Job Description

The Package Development Engineering Contractor is responsible for supporting the Packaging Systems team member on Research and Development projects, Lifecycle Engineering projects or portions of major Packaging Systems development projects. The candidate must demonstrate the following capabilities: 

Be able to apply knowledge of engineering principles and practices within assignment areas. 

Plan, execute and controlling major sections of new package development projects. 

Provide consultation and leadership on Package Engineering issues for operations and packaging strategies. 

Be able to assess new packaging techniques and overall operations packaging capabilities, planning, and development, coordinating and directing package engineering projects concerned with unique problems which have an important effect on major company programs. 

Direct the package development sub-team members to accomplish packaging and non-packaging related projects. 


Key Job Responsibilities: 

Work in conjunction with the label development group to deliver packaging components in a timely manner for Research and Development and Packaging Systems projects. 

Conduct assignments encompassing complete projects or portions of major projects requiring advanced knowledge of a specialized field. 

Make decisions independently on engineering problems and methods. 

Plan, conduct and direct major sections of new package development projects. 

Determine methods and techniques to be used or adapts standard methods to meet variations. 

Utilize technical competency, relevant work experience, and comprehensive and diverse package engineering knowledge to generate valid creative solutions. 

Coordinate and direct the activities of technical support staff (both in-house and outside) in order to achieve objectives. 

Design, develop, validate, and oversee manufacture, installation, and operation of package components and packaging processes for sterile surgical devices. 

Plans, develops, coordinates and directs a number projects of major scope and importance. 

Has full technical responsibility for interpreting, organizing, executing and coordinating assignments. 

Develop general packaging guidelines and standards for processes and functional requirements. 

No direct reports 

Overnight travel may be required of up to10%. 

Other responsibilities may be assigned and not all responsibilities listed may be assigned. 


Qualifications

Qualifications: 

A minimum of a Bachelor's degree in engineering is required. Package Engineering degree preferred. 

Minimum of three years of experience working in industry required with one year of experience in packaging development. Regulated industry experience is an asset for this role along with medical device experience. 

Experience with project management is preferred. 

Experience in packaging design preferred 

Design verification and validation is preferred. 

The ability to effectively communicate, written and verbally, technical information and its implications to non-technical staff is preferred. 

The ability to apply Six Sigma and/or lean tools is an asset. 

Professional judgment to generate valid solutions to technical assignments is preferred. 

The ability to function independently on specific assignment objectives requiring investigation of a limited number of variables and to function effectively with limited supervision is preferred. 

Having the professional judgment required to resolve technical, package design, development and/ or processing issues, identifying the timing, and understand the interrelationships of key activities are all highly preferred. 

Knowledge of packaging graphics, process development validation, testing, equipment and supplier processes are preferred. 

Materials testing, documentation and ISO 11607 are also preferred for this role. 

Personal computer skills should include the ability to effectively use Windows word processing, project planning, presentation, e-mail and spreadsheet software is required. 

The ability to create packaging documentation using CADD (Computer-Aided Drafting and Design) software is preferred. 


Education (degree preferred or required): B.S., Packaging Science preferred 

Years of Experience Needed/Preferred: 1.5 needed, 2+ preferred 

Technical Experience (ex: Word, Excel, etc.): MS Office, WORD, EXCEL, PROJECT - required. CAD skills an asset. Package Lab Experience an asset.

Additional Information

LanceSoft logo

About LanceSoft

Sourced by ZipRecruiter

Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization. Lancesoft Inc. is one of the highest rated companies in the industry. We have been recognized as one of the Largest Staffing firms and ranked in the top 50 fastest Growing Healthcare Staffing firms in 2022. Lancesoft offers short- and long-term contracts, permanent placements, and travel opportunities to credentialed and experienced professionals throughout the United States. We pride ourselves on having industry leading benefits. We understand the importance of partnering with an expert who values your needs, which is why we're 100% committed to finding you an assignment that best matches your career and lifestyle goals. Our team of experienced career specialists takes the time to understand your needs and match you with the right job Lancesoft has been chosen by Staffing Industry Analysts as one of the Best Staffing Firms to Work for.LanceSoft specializes in providing Registered Nurses, Nurse Practitioners, LPNs/LVNs, Social Workers, Medical Assistants, and Certified Nursing Assistants to work in Acute Care Centers, Skilled Nursing Facilities, Long-Term Care centers, Rehab Facilities, Behavioral Health Centers, Drug & Alcohol Facilities, Home Health & Community Health, Urgent Care Clinics, and many other provider-based facilities.

Industry

Recruiting and staffing services

Company size

1,001 - 5,000 Employees

Headquarters location

Herndon, VA, US

Year founded

2000

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