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Iso 11607 Jobs in Wisconsin (NOW HIRING)

Quality Systems Engineer

Neenah, WI · On-site

$63K - $95K/yr

Relevant standards may include ISO 9001, ISO 13485, AS 9100, Nadcap, ISO 14001, etc. Supports the design and installation of the quality system. Assists to communicate quality system and regulatory ...

QUALITY ENGINEER

Port Washington, WI · On-site

$68K - $87K/yr

Under the direction of the Quality Manager, the Quality Engineer is responsible for the materials in-process and finished products, ensuring conformance to ISO 13485 and company quality standards ...

QUALITY ENGINEER

Port Washington, WI · On-site

$68K - $87K/yr

Under the direction of the Quality Manager, the Quality Engineer is responsible for the materials in-process and finished products, ensuring conformance to ISO 13485 and company quality standards ...

This role partners with plant leadership, suppliers, and customers to drive continuous improvement, enhance process capability, reduce quality costs, and ensure compliance with ISO and customer ...

Sr. Quality Engineer

Richfield, WI · On-site

$88K - $119K/yr

QS / ISO System experience. * Previous auditing experience. * Experience with ISO class 8 cleanroom. * Experience in working with a team, ability to drive change and influence cultural change. To ...

Responsible for the Quality Management System and its overall effectiveness supporting the Company's strategies while ensuring ISO 9001 compliance * Provide leadership to the Quality staff and ...

This position will have ownership of the Quality Management System, including ISO 9001 compliance, APQP, PPAP, CAPA, nonconforming material, metrology, process controls, and continuous improvement ...

WI · On-site

$125 - $150/hr

Supports integration of ISO 14971 risk management, IEC 62366 usability engineering, and FDA cybersecurity guidance into SDLC processes, ensuring a cohesive and compliant approach to product safety ...

QUALITY ENGINEER

Port Washington, WI · On-site

$68K - $87K/yr

Under the direction of the Quality Manager, the Quality Engineer is responsible for the materials in-process and finished products, ensuring conformance to ISO 13485 and company quality standards ...

Quality Engineer

Hartford, WI · On-site

$60K - $72K/yr

Ensure compliance with ISO 9001 and ISO 14001 requirements. * Participate in and support internal audits, customer audits, and regulatory assessments. * Maintain awareness and application of ...

This role ensures that US Transplant Technololgy CAPA and complaint processes comply with FDA, ISO 13485, IVDR, and other global regulatory requirements while driving operational excellence. Quality ...

Responsible for the Quality Management System and its overall effectiveness supporting the Company's strategies while ensuring ISO 9001 compliance * Provide leadership to the Quality staff and ...

Quality Manager

Oak Creek, WI · On-site

$100 - $125/hr

Ensures compliance with FDA 21 CFR Part 820, ISO 13485, and internal SOPs. * Supports internal and external audits by preparing documentation and leading inspection activities. * Collaborates with ...

Showing results 41-60

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 Wisconsin?

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

What cities in Wisconsin are hiring for Iso 11607 jobs?

Cities in Wisconsin with the most Iso 11607 job openings:

Quality Systems Engineer

Plexus Corp.

Neenah, WI • On-site

$63K - $95K/yr

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 10 days ago


Key responsibilities

  • Lead, manage and/or participate in internal and external audits for applicable market sectors including customer audits/visits, regulatory inspections and registrar/certification audits.

  • Manage, support or coordinate Corrective and Preventive actions to ensure timely response, follow through, and appropriate reporting to management.

  • Assist with special projects to improve the quality management system, including process validations and documentation such as assembly build instructions, device travelers, certificates of compliance, complaint files, DMRs, DHRs.


Plexus Corp. rating

8.2

Company rating: 8.2 out of 10

Based on 13 frontline employees who took The Breakroom Quiz

46th of 161 rated electronics manufacturers


Job description

About us: At Plexus, our vision is to help create the products that build a better world. Driven by a passion for excellence, we partner with leading Aerospace/Defense, Healthcare/Life Sciences and Industrial companies to design, manufacture and service some of the world's most transformative products, including advanced surgical systems, diagnostic instruments, healthcare imaging equipment, mission critical aerospace systems, and electric vehicle (EV) charging solutions. Visit Plexus.com to learn more about our unwavering commitment to our vision

When we invest in our people, we invest in building a better world. With a vision rooted in the wellbeing and inclusive engagement of our team members, our customers, their end users and our communities, people are the heart of what we do and who we are. It is our values that unite us and guide us in everything that we do, including how we operate, behave and interact to foster a workplace where every team member feels valued and empowered to contribute their best.

Our values include: Growing our People, Building Belonging, Innovating Responsibly, Delivering Excellence and Creating Customer Success. As a team member, you will engage in impactful work through global collaboration and the use of emerging technologies, join an inclusive culture where every team member is valued and working toward a greater purpose, and be empowered to reach your full potential through various development programs designed to accelerate your growth. Plexus offers a comprehensive benefits package designed to support team members' wellbeing, including medical, dental, and vision insurance, paid time off, retirement savings, and opportunities for professional development.

We also prioritize work-life balance and offer a variety of perks to enhance the team member experience. For more information, visit our US benefits website at usbenefits.plexus.com. Our commitment to pay range transparency fosters an equitable workplace, where everyone can feel valued

The annual compensation range for this position is stated below. The salary offered within this range will be based upon the geographic location, work experience, education, licensure requirements and/or skill level. Salary Range: $63,900.00 - $95,900.00 Purpose Statement: Aid in ensuring compliance and continual improvement activities for the Plexus Quality Management Systems

Key Job Accountabilities: Lead, manage and/or participate in internal and external audits for applicable market sectors including customer audits/visits, regulatory inspections and registrar/certification audits as requested. This may include creating and maintaining the internal audit schedule. Manage, support or coordinate Corrective and Preventive actions to ensure timely response, follow through, and appropriate reporting to management.

Work on special projects as requested to improve the quality management system, which may include assisting with process validations, or documentation such as assembly build instructions, device travelers, certificates of compliance, complaint files, DMRs, DHRs, etc. Assist to establish regulatory guidelines and industrial standards in quality system and work with site quality managers to ensure compliance at sites/region. Remain abreast of new and ever-changing applicable quality system standards and regulatory requirements.

Relevant standards may include ISO 9001, ISO 13485, AS 9100, Nadcap, ISO 14001, etc. Supports the design and installation of the quality system. Assists to communicate quality system and regulatory requirements with internal customers.

Education/Experience Qualifications: Bachelor's Degree with 2 or more years of related experience is preferred. An equivalent combination of education and/or experience will be considered. Other Qualifications: Employee must be self-motivated with the ability to work independently and in a team environment.

Good oral and written communication skills are necessary. Attention to detail, good problem solving skills, and computer literacy are essential. Project management and knowledge of ISO 9001, ISO 13485 and AS9100 a benefit, but not required.

Physical Requirements: Professional office environment with suitable lighting, comfortable temperatures, and low noise level. May require prolonged periods of sitting at a desk, using a computer, and other office equipment. Minimal physical activity is generally involved, emphasizing the importance of good posture and ergonomic workplace arrangements.

Travel Requirements: Less than 10% This document does not represent a contract of employment and is not intended to capture every possible assignment the incumbent could be asked to perform. We are pleased to provide reasonable accommodations to individuals with disabilities or special requirements. If you need an application accommodation, please contact us by email at GHQ.TA@plexus.com

Please include your contact information and clearly describe how we can help you. This email is for accommodation requests only and cannot be used to inquire about the status of applications. We are an Equal Opportunity Employer (EOE) and do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Some offers of employment are contingent upon successfully passing a drug screen and/or background check.


What Plexus Corp. employees say

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Benefits

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About Plexus

Sourced by ZipRecruiter

Industry

Electrical equipment, appliance, and component manufacturing

Company size

10,000+ Employees

Headquarters location

Neenah, WI, US

Year founded

1979