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Iso 11607 Jobs in Wisconsin (NOW HIRING)

Amcor

Manufacturing Quality Engineer

New London, WI

$68K - $88K/yr

Assisting with process validations (IQ, OQ, & PQ) and product validations as per customer requirements and ISO-11607 * Support manufacturing units with analyzing failures, preventive and corrective ...

Amcor plc

Manufacturing Quality Engineer

New London, WI · On-site

$68K - $88K/yr

Assisting with process validations (IQ, OQ, & PQ) and product validations as per customer requirements and ISO-11607 * Support manufacturing units with analyzing failures, preventive and corrective ...

Anonymous Employer

Quality Manager

Madison, WI

$38.46 - $49.04/hr

Maintain and improve the company's ISO quality system. * Manage PPAP documentation and customer quality requirements. * Work closely with production to identify and resolve quality issues. * Review ...

TCLAD INC

Quality Engineer

Prescott, WI · On-site

$73K - $94K/yr

Perform ISO/TS internal auditing as required by the Quality Manager. * Responsible for continued compliance with documentation in the ISO/TS quality system. * Responsible for training inspectors to ...

Smiths Machine

Regulatory Quality Engineer

Kenosha, WI · On-site

$70K - $90K/yr

Leads and/or participates in the development, implementation, compliance, and maintenance of standards (FDA, ISO 13485:2016, etc.) and procedures. * Acts as a direct contact for FDA. Ensures FDA ...

ARCH Global Precision

Regulatory Quality Engineer

Kenosha, WI · On-site

$70K - $90K/yr

Leads and/or participates in the development, implementation, compliance, and maintenance of standards (FDA, ISO 13485:2016, etc.) and procedures. * Acts as a direct contact for FDA. Ensures FDA ...

Allegis Corporation

Quality Manager

Slinger, WI · On-site

$80 - $100/hr

Coordinate internal and external ISO 9001 audits and support successful completion of certification and surveillance audits. * Monitor QMS performance and report quality objectives, metrics, and ...

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All JobsIso 11607 JobsIso 11607 Jobs in Wisconsin

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.

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

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

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

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Iso 11607 jobs near you

Converting Supervisor

PPC INDUSTRIES INC

Pleasant Prairie, WI • On-site

$60 - $80/hr

Other

Posted 6 days ago

Key responsibilities

  • Own end‑to‑end shift operations, including staffing, production flow, and issue resolution.

  • Supervise operators, packers, material handlers, and personnel supporting production.

  • Ensure products meet defined specifications and quality standards.

Job description

Position Overview

The Production Supervisor is a key link between management and the production workforce, responsible for safe, compliant, and efficient shift execution in a medical sterile packaging (converting) environment. This role ensures production activities meet quality, regulatory, and safety requirements, while leading and developing operators to achieve daily performance targets. The supervisor escalates production, quality, and personnel issues to site leadership in a timely manner.

Key ResponsibilitiesSafety & Compliance
  • Lead by example in enforcing safety policies, GMPs, and cleanroom behaviors.
  • Maintain a clean, organized, and contamination‑controlled work environment.
  • Ensure compliance with ISO 13485, ISO 11607, and internal procedures.
Production & Shift Execution
  • Own end‑to‑end shift operations, including staffing, production flow, and issue resolution.
  • Supervise operators, packers, material handlers, and personnel supporting production.
  • Make real‑time decisions during off‑hours or limited‑support periods to maintain production continuity.
Quality Oversight
  • Ensure products meet defined specifications and quality standards.
  • Enforce standard work, accurate documentation, and adherence to work instructions.
  • Support investigations, deviations, and corrective actions as needed.
Training & Team Development
  • Ensure employees are trained and qualified for assigned tasks.
  • Coach and develop team members through on‑the‑floor engagement and feedback.
  • Reinforce cleanroom procedures, equipment operation, and safety practices.
Scheduling & Staffing
  • Develop and manage shift schedules to ensure adequate coverage and efficient operations.
  • Adjust staffing to meet production demands while maintaining compliance.
Problem Solving & Communication
  • Address equipment, quality, or personnel issues as they arise.
  • Partner with Quality, Engineering, Maintenance, and Training teams to resolve issues.
  • Ensure effective shift handoffs and communication of key issues and metrics.
Documentation & Metrics
  • Maintain accurate shift reports, production records, and quality documentation.
  • Track and communicate performance against safety, quality, delivery, and cost metrics.
  • Use visual management and daily metrics to identify gaps and drive corrective action.
Inventory & Materials
  • Monitor packaging material usage and inventory levels.
  • Report shortages or issues to procurement and leadership.
Continuous Improvement
  • Identify and implement process improvements to enhance efficiency, quality, and safety.
  • Support site initiatives related to operational excellence and standardization.
QualificationsEducation & Experience
  • Associate degree preferred or equivalent leadership experience.
  • 2–4 years of supervisory or team‑lead experience, preferably in a cleanroom or medical device manufacturing environment.
Skills & Competencies
  • Strong leadership and decision‑making skills.
  • Effective problem‑solving and attention to detail.
  • Strong communication skills; bilingual English/Spanish preferred.
  • Proficient with computers and software (Microsoft Office, ERP/MES systems).
Physical Requirements
  • Ability to lift up to 50 lbs. regularly.
  • Ability to stand, walk, and perform manual tasks for extended periods.
  • Manual dexterity to handle small components.
  • Basic math and analytical capability.
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