ZipRecruiter

Log In

1

Iso 11607 Jobs in Wisconsin (NOW HIRING)

Custom Wire Technologies

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 ...

Standard Iron

Quality Engineer

Hartford, WI · On-site

$62K - $70K/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 ...

JellTech Consulting

Be Seen First

Quality Supervisor

Waupaca, WI · On-site

$30 - $35/hr

The Quality Supervisor supports compliance with customer requirements, ISO 9001:2015 standards, and ITAR regulations while overseeing inspection activities, CMM programming, First Article Inspections ...

New

Custom Wire Technologies

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 ...

Systems LLC

Engineer III, Quality

Germantown, WI · On-site

$73K - $94K/yr

Develop and execute an internal audit program (ISO 9001:2015 clause 9.2) to monitor conformance to Quality Procedures and Inspection/Test Instructions; prepare management review inputs (clause 9.3) * ...

Asyst Technologies L P

Quality Engineer

Kenosha, WI · On-site

$70K - $90K/yr

Support and maintain compliance with IATF 16949, ISO 9001, and ISO 14001 standards * Conduct internal audits and support quality system improvements * Assist with lean manufacturing and continuous ...

SPX

$89K - $120K/yr

Develop, implement, and continuously improve ISO 9001 quality systems, procedures, work instructions, and documentation supporting manufacturing operations * Support new facility startup activities ...

Actalent

Quality Manager

Milwaukee, WI

$90K - $100K/yr

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

previous page

Showing results 41-60

All JobsIso 11607 JobsIso 11607 Jobs in Wisconsin

Iso 11607 information

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 Wisconsin? 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:
What cities in Wisconsin are hiring for Iso 11607 jobs? Cities in Wisconsin with the most Iso 11607 job openings:
Iso 11607 jobs near you

Quality Engineer - Systems Assurance

Werfen

Waukesha, WI • On-site

Full-time

Re-posted 15 days ago

Werfen rating

8.7

Company rating: 8.7 out of 10

Based on 27 frontline employees who took The Breakroom Quiz

Job description

Introduction
Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.
Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care
Overview
The Quality Engineer - CAPA and Customer Complaint is responsible for overseeing corrective and preventive actions, managing customer complaints, and ensuring compliance with quality and regulatory standards. 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 Assurance Systems Engineer (Systems QA / Compliance / Engineering / Medical Device / Health Care)
Responsibilities
Key Accountabilities
CAPA Management:
  • Oversee the end-to-end CAPA process, ensuring timely identification, investigation, and closure of corrective and preventive actions
  • Supports the review of root cause analyses (e.g., 5 Whys, Fishbone Diagrams, FMEA) to ensure proper and thorough investigations have been conducted and identify systemic issues
  • Ensure CAPA effectiveness checks are conducted and documented per regulatory requirements
  • Provide training and mentorship to internal teams on effective investigation techniques and documentation best practices
  • Drive continuous improvement initiatives to optimize efficiency and compliance

Complaint Handling & Investigation:
  • Manage the customer complaint process; investigation, documentation and resolution
  • Coordinate cross-functional teams (Technical Support, Quality, Regulatory, and Manufacturing) to investigate complaints and implement corrective actions
  • Ensure MDR/IVDR and FDA 21 CFR 803 compliance for reportable events

Regulatory Compliance & Audits:
  • Ensure CAPA and complaint processes align with FDA, ISO 13485, EU IVDR, and other global regulations
  • Serve as Subject Matter Expert (SME) during regulatory audits and inspections
  • Maintain compliant and CAPA metrics for Management Review and continuous improvement initiatives
  • Provide training and mentorship to internal teams on effective investigation techniques and documentation best practices
  • Drive continuous improvement initiatives to optimize efficiency and compliance
  • Support other Quality Management Systems as required; applicable subsystems include, but are not limited to, supplier management, risk management and change control
  • Other duties as assignedeasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Networking/Key relationships
  • Daily interaction with all departments domestic and international to support CAPA training and CAPA Closure.
  • Interaction with Manufacturing Technical Support team in support of product investigations.
  • Interaction with Research and Development to support product complaints and product improvements.
  • Interaction with Quality Assurance for quality and regulatory compliance.
  • Interaction with Customer Technical Support team in support of customer complaint investigation.

Quality Assurance Systems Engineer (Systems QA / Compliance / Engineering / Medical Device / Health Care)
Qualifications
Quality Assurance Systems Engineer (Systems QA / Compliance / Engineering / Medical Device / Health Care)
Minimum Knowledge & Experience required for the position:
  • Bachelor's degree in Engineering, Life Sciences, Quality, and/or related fields; Master's degree preferred
  • Minimum 7 years of experience in medical device, pharamaceutical, or biotechnology industries with a focus on CAPA and complaint handling. (Preferably direct experience with IVD's for HLA screening, and ELISA products)
  • Strong understanding of FDA 21 CFR 820, ISO 13485, EU MDR, and global quality system regulations
  • Expertise in CAPA investigations, root cause analysis (RCA), and risk management (ISO 14971)
  • Experience with electronic QMS (eQMS) systems (e.g.,TrackWise, MasterControl, SAP)
  • Strong analytical, communication, and leadership skills
  • Excellent verbal and written communication skills
  • Exhibits a disciplined approach to work ensuring thoroughness, consistency, validation, and accuracy in all tasks and work product
  • Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement Skills & Capabilities:
  • Effective communication
  • Strong leadership
  • Proactive problem-solving
  • Stategic thinking
  • Organizational skills and time management
  • Coaching skills for improvement and problem solving
  • Continous learning and development mindset
  • Conflict resolution
  • Foster a positive and inclusive work environmentTravel requirements:
  • 5% or less annually

Closing
If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.
Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.
We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.
www.werfen.com

What Werfen employees say

Pay

Benefits

Hours and flexibility

Workplace

Get the full story on Breakroom

Werfen logo

About Werfen

Sourced by ZipRecruiter

Industry

Health care and social assistance

Company size

1,001 - 5,000 Employees

Headquarters location

L'Hospitalet de Llobregat, Barcelona, ES

View All Werfen Jobs

Apply