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Iso 11607 Jobs in Racine, WI (NOW HIRING)

Twin Disc, Incorporated

Quality Supervisor

Racine, WI · On-site

Stay current with industry best practices and ISO 9001 standards Qualifications Required * 5+ years of machining experience in an ISO 9001 (or similar) environment * 5+ years of hands-on inspection ...

Twin Disc, Inc.

Quality Supervisor

Racine, WI · On-site

Stay current with industry best practices and ISO 9001 standards Qualifications Required * 5+ years of machining experience in an ISO 9001 (or similar) environment * 5+ years of hands-on inspection ...

Alto-Shaam

Quality Engineer III

Menomonee Falls, WI

$72K - $93K/yr

Serve as a Lead Internal Auditor to support Alto-Shaam's ISO 9001 certification * Other project work as assigned Qualifications * Prepare reports by collecting, analyzing, and summarizing data in ...

Alto-Shaam

Quality Engineer III

Menomonee Falls, WI

$72K - $93K/yr

Serve as a Lead Internal Auditor to support Alto-Shaam's ISO 9001 certification * Other project work as assigned Qualifications * Prepare reports by collecting, analyzing, and summarizing data in ...

Alto-Shaam

Quality Engineer III

Menomonee Falls, WI · On-site

$72K - $93K/yr

Serve as a Lead Internal Auditor to support Alto-Shaam's ISO 9001 certification * Other project work as assigned Qualifications * Prepare reports by collecting, analyzing, and summarizing data in ...

Tecnova Electronics Inc

Quality Inspector

Waukegan, IL · On-site

$18 - $22/hr

Ensure compliance with ISO 9001 quality standards * Document inspection results and report non-conformances * Collaborate with production and engineering teams to resolve issues Minimum ...

Merck Group

Quality Engineer

Milwaukee, WI · On-site

$69K - $115K/yr

General understanding of (current) Good Manufacturing Practices and ISO Quality Systems * Competent knowledge of and ability to use Microsoft Word, Excel, Access, SAP and eDMS systems. * Detail ...

Tecnova Electronics Inc

Quality Inspector

Waukegan, IL · On-site

$18 - $22/hr

Ensure compliance with ISO 9001 quality standards * Document inspection results and report non-conformances * Collaborate with production and engineering teams to resolve issues Minimum ...

ATI

Quality Leader

Cudahy, WI

Provide necessary support to insure continuous compliance to ISO 9002/AS9100A and any other customer specific inspection processes. * Review of internal and external customer drawings to determine ...

MPE-Inc

Quality Manager

Sturtevant, WI · On-site

Maintain Medical Device Files and records per ISO 13485 requirements. If you enjoy working in a fast-paced environment where precision and teamwork matter, we'd love to hear from you! Shift Available ...

Next Gen Alloys

Quality Leader

Cudahy, WI

Provide necessary support to insure continuous compliance to ISO 9002/AS9100A and any other customer specific inspection processes. * Review of internal and external customer drawings to determine ...

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Showing results 41-60

All JobsIso 11607 JobsIso 11607 Jobs in Racine, WI

Iso 11607 information

See Racine, WI salary details

$27.7K

$82.2K

$133.6K

How much do iso 11607 jobs pay per year?

As of Aug 11, 2026, the average yearly pay for iso 11607 in Racine, WI is $82,205.00, according to ZipRecruiter salary data. Most workers in this role earn between $58,600.00 and $105,500.00 per year, depending on experience, location, and employer.

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 Racine, WI? For Iso 11607 jobs in Racine, WI, the most frequently searched job titles are:
What job categories do people searching Iso 11607 jobs in Racine, WI look for? The top searched job categories for Iso 11607 jobs in Racine, WI are:
What cities near Racine, WI are hiring for Iso 11607 jobs? Cities near Racine, WI with the most Iso 11607 job openings:
Iso 11607 jobs near you
Infographic showing various Iso 11607 job openings in Racine, WI as of August 2026, with employment types broken down into 90% Full Time, 2% Part Time, 6% Contract, and 2% Nights. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution, with an average salary of $82,205 per year, or $39.5 per hour.

Supplier Quality Engineer

Aquinas Consulting

Menomonee Falls, WI • On-site

Full-time

Re-posted 2 days ago

Job description

Aquinas Consulting is currently looking to fill a Supplier Quality Engineer job in Menomonee Falls, WI. This DIRECT hire job is available with one of our key clients in the defense and naval power systems industry. In this role, you will support supplier quality initiatives, drive continuous improvement, and ensure purchased components meet quality and customer requirements throughout the product development process. To be successful in this position, you should have experience with supplier quality, quality systems, and root cause analysis. Preference will be given to professionals with experience supporting manufacturing environments, military specifications, and ISO quality standards. U.S. Citizenship and the ability to obtain a DoD security clearance are required.

Supplier Quality Engineer Job Responsibilities:

  • Partner with suppliers to implement corrective actions, improve quality control plans, eliminate defects, and support supplier development and continuous improvement initiatives.
  • Develop and maintain quality plans, procedures, and schedules that translate customer and program requirements into effective quality processes while reviewing engineering, test, and contractor documentation for compliance.
  • Support quality systems by performing internal audits, leading root cause investigations, participating in Material Review Boards and Failure Review Boards, and driving corrective actions for nonconforming products.
  • Provide technical guidance to assembly, test, and inspection teams by developing inspection methods, sampling plans, workmanship standards, and resolving quality issues throughout the manufacturing process.
  • Evaluate supplier performance through on-site audits, prototype reviews, statistical analysis, and supplier corrective actions while recommending improvements to supplier selection and manufacturing processes.
  • Establish and monitor quality programs that verify the accuracy of production, testing, and measurement equipment while assessing the operational and financial impact of quality controls and inspection activities.

Qualifications:

  • Bachelor's degree in Engineering or a related technical field, or an equivalent combination of education and experience, with at least two years of quality engineering experience.
  • Experience with supplier quality, quality systems, ISO standards, Six Sigma tools, statistics, and continuous improvement methodologies.
  • Ability to interpret military specifications, engineering drawings, blueprints, and technical documentation.
  • Strong problem-solving, root cause analysis, communication, negotiation, and technical writing skills.
  • U.S. Citizenship is required, along with the ability to obtain and maintain a Department of Defense (DoD) security clearance.

If you are interested in this Supplier Quality Engineer job in Menomonee Falls, WI, please apply now to be connected with a member of our team.

Please note: Applying to this role is an agreement to have your information entered into our database and acknowledgement that a recruiter will reach out to you either by phone, email, and/or text message regarding this and similar job opportunities.

Aquinas Consulting is a woman and minority owned company headquartered in Milford, CT that provides Engineering, Information Technology (IT), and Manufacturing staffing solutions throughout the US. We take pride in 20 years of service to our clients, our hiring managers, our consultants, and our local community. Aquinas is an affirmative action, equal opportunity employer and is committed to considering all qualified applications without regard to race, genetic information, sex, age, color, religion, national origin, veteran status, disability, or any other characteristic protected by law. www.aquinasconsulting.com