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Iso 11607 Jobs in Racine, WI (NOW HIRING)

ISO standards Additional Skills & Qualifications * Experience in manufacturing, preferably in a leadership role * Experience programming and using coordinate measuring equipment * Proficiency in ...

Quality Engineer II

Kenosha, WI · On-site

$70K - $90K/yr

Knowledge of ISO 13485 Quality Management System & FDA 21CFR 820 Regulations. * Knowledge of Geometric Dimensioning and Tolerancing per ASME Y14.5M. * Familiarity with test methods and standards for ...

Quality Engineer II

Kenosha, WI · On-site

$70K - $90K/yr

Knowledge of ISO 13485 Quality Management System & FDA 21CFR 820 Regulations. * Knowledge of Geometric Dimensioning and Tolerancing per ASME Y14.5M. * Familiarity with test methods and standards for ...

Maintain compliance with ISO 9001, AS9100 and other applicable standards * Ensure quality policies, procedures, work instructions and documentation remain current * Monitor compliance with customer ...

Quality Engineer

Milwaukee, WI

$70K - $91K/yr

Perform internal audits in accordance with ISO 9001 and other applicable quality standards to ensure ongoing compliance. * Ensure continual improvement in process and product design by identifying ...

Quality Engineer

Milwaukee, WI

$70K - $91K/yr

Perform internal audits in accordance with ISO 9001 and other applicable quality standards to ensure ongoing compliance. * Ensure continual improvement in process and product design by identifying ...

Proficiency in ISO 9001 or AS9100D standards. * Expertise in root cause analysis and audit processes. * Strong leadership and customer interaction skills. * Experience with electronics manufacturing.

New

Strong knowledge of IATF 16949 and/or ISO 9001 Quality Management Systems. * Experience with APQP, PFMEA, Control Plans, SPC, MSA, 8D, 5 Why, and Lean Manufacturing principles. * Proven success ...

Quality Manager

Racine, WI · On-site

$90K - $110K/yr

Requirements → Minimum 5 years of quality experience → Strong ISO 9001 knowledge and internal auditing experience → Experience interfacing directly with customers on quality matters → ...

Quality Engineer

Franklin, WI · On-site

$100K - $118K/yr

Ensure compliance with applicable quality standards (ISO, customer-specific requirements, etc.) * Maintain proper documentation and reporting to support audits and regulatory needs Qualifications:

... ISO compliance, certification efforts, and ongoing audit readiness. 2. Inspection & Product Quality · Oversee incoming, in-process, and final inspection activities. · Develop inspection plans ...

Manufacturing Engineer

Milwaukee, WI · On-site

$71K - $92K/yr

Provide support as required to GMP, safety, ISO and internal audits. Requirements Knowledge and experience working within an ISO 13485 compliant business systems. Demonstrated use of DFSS (DOE ...

Showing results 21-40

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 10, 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:
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.

Quality Manager

Actalent

Milwaukee, WI

$90K - $100K/yr

Full-time

Medical, Dental, Vision, Retirement

Posted 6 days ago


Job description

Job Title: Quality ManagerJob Description

Under the guidance of the Director of Quality, the Quality Manager will collaborate with various functional areas such as manufacturing, engineering, sales, human resources, and finance. The primary goal is to ensure that products and processes comply with ISO9001, ISO13485, FDA, and other regulatory standards.

Responsibilities
  • Prioritize, schedule, and delegate work assignments while directly supervising quality technicians to ensure conformance to customer product specifications, standards, and regulatory requirements.
  • Communicate with customers regarding issues, requests, and new product introductions.
  • Host customer and regulatory audits.
  • Manage the material review board process, part production approval process (PPAP), first article inspection, internal audit schedule, quality team’s work hours, calibration schedule, quality control plans, and receiving inspection.
  • Assist in measuring parts requiring first article, in-process, and final inspection using a Romer Arm, Microview, CMM, or other metrology equipment as necessary.
  • Oversee the review and creation of control plans on prototype builds.
  • Assist in establishing and implementing quality procedures, specifications, testing procedures, and standards for raw materials, in-process, and finished products.
  • Process customer returns and facilitate closure of non-conformance cases with the customer.
  • Communicate the voice of the customer plant-wide.
  • Develop training curriculum and train employees in quality-related practices and system requirements.
  • Analyze internal and customer return/complaint data to identify corrective and preventive actions.
  • Participate in cross-functional teams to support continuous improvement projects to enhance quality and productivity.
  • Coach problem-solving techniques such as 5 why, fishbone, Pareto, and 8D methods.
  • Use capability studies and gage reproducibility and repeatability along with Six Sigma methods to analyze process and measurement variations.
  • Manage complaints, CAPA, and non-conforming products per applicable ISO 9001 requirements.
  • Manage inputs and KPI metrics for management review processes per ISO 9001 requirements.
Essential Skills
  • Root cause analysis
  • Quality management
  • Metal fabrication
  • PPAP APQP
  • Quality audit
  • ISO standards
Additional Skills & Qualifications
  • Experience in manufacturing, preferably in a leadership role
  • Experience programming and using coordinate measuring equipment
  • Proficiency in using handheld gages such as calipers, micrometers, and thread gages
  • Experience in problem identification, resolution, and prevention
  • Preferred experience in Six Sigma, ISO, and FDA standards
  • Experience with low-volume, high product mix fabrication processes such as punch press, laser cutting, progressive die stamping, forming, hardware insertion, welding, and metal fabrication
Work Environment

The role involves working closely with different departments to ensure compliance and quality standards. The position requires the use of various metrology equipment and tools. The work environment encourages continuous improvement and problem-solving to maintain high-quality standards and productivity.

Job Type & Location

This is a Permanent position based out of Milwaukee, WI.

Pay and Benefits

The pay range for this position is $90000.00 - $100000.00/yr.

401k, health, dental, vision

Workplace Type

This is a fully onsite position in Milwaukee,WI.

Application Deadline

This position is anticipated to close on Aug 18, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.


Actalent logo

About Actalent

Sourced by ZipRecruiter

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

Company size

5,001 - 10,000 Employees

Headquarters location

Hanover, MD, US

Year founded

1983

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