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Iso 11607 Jobs in Minnesota (NOW HIRING)

NPD Quality Engineer

Delano, MN · On-site

$78K - $97K/hr

ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable), EU/MDR. Responsibilities: * Knowledgeable and adheres to TMS Quality Management System and its requirements. * Works with the ...

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Senior Quality Engineer

Minneapolis, MN

$92K - $125K/yr

Ensure ongoing compliance with FDA QSR (21 CFR 820), ISO 13485, and applicable regulatory and quality system requirements * Serve as the Quality representative on operations and sustaining teams ...

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Quality Engineer

Saint Paul, MN · On-site

$65K - $90K/yr

This role ensures that manufactured products meet high standards through timely investigation, containment, and resolution, while maintaining strict compliance with ISO 9001 requirements and internal ...

NPD Quality Engineer

Delano, MN · On-site

$78K - $97K/yr

ISO 9000/9001, ISO 13485, and FDA 21CFR 820/11 (4/210/211 as applicable), EU/MDR. Responsibilities: * Knowledgeable and adheres to TMS Quality Management System and its requirements. * Works with the ...

Quality Inspector

Saint Paul, MN · On-site

$32 - $35/hr

Maintain ISO 9001 & Quality System and continuous improvement. * Ensure Quality equipment has current calibration * Perform daily Quality inspection of incoming material and components to ensure ...

Familiar with ISO 13485 or ISO 9001 Quality Management Systems * Calibration **The benefits you will receive as a Marshall employee **: * Competitive wages with growth potential * Monthly profit ...

Manage, maintain, and improve the company's QMS in alignment with ISO 9001, ISO 13485, AS9100, and internal procedures * Identify gaps or conflicts between SOPs, work instructions, and regulatory ...

Quality Systems Engineer

Plymouth, MN · On-site +1

$69K - $92K/yr

Manage, maintain, and improve the company's QMS in alignment with ISO 9001, ISO 13485, AS9100, and internal procedures * Identify gaps or conflicts between SOPs, work instructions, and regulatory ...

Sr. Quality Engineer

Chaska, MN · On-site

$94K - $128K/yr

Implements and maintains ISO 14971 Risk Management requirements within procedures and design documentation SUPERVISION RECEIVED AND EXERCISED * Reports to the Vice President of Operations, QARA, and ...

Showing results 41-60

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 Minnesota? For Iso 11607 jobs in Minnesota, the most frequently searched job titles are:
What job categories do people searching Iso 11607 jobs in Minnesota look for? The top searched job categories for Iso 11607 jobs in Minnesota are:
What cities in Minnesota are hiring for Iso 11607 jobs? Cities in Minnesota with the most Iso 11607 job openings:

Quality Engineer - Aerospace Manufacturing - Big Lake

Howmet

Big Lake, MN • On-site

$64K - $110K/yr

Other

Posted 9 days ago


Howmet Aerospace rating

7.9

Company rating: 7.9 out of 10

Based on 160 frontline employees who took The Breakroom Quiz

45th of 72 rated aerospace companies


Job description

Job Info
  • Job Identification 118759
  • Job Category Quality
  • Posting Date 07/31/2026, 08:46 PM
  • Locations 17465 198th Avenue NW, Big Lake, MN, 55309, US (On-site)
  • Job Schedule Full time
  • Export-Controlled Data This position entails access to export-controlled items and employment offers are conditioned upon an applicant's ability to lawfully obtain access to such items
, Responsibilities

Position Summary:

This position is responsible for developing and maintaining manufacturing quality plans along with project-specific quality plans, compiling and analyzing statistical data in order to assess process capabilities and control processes, investigating and resolving CAPAs, performing internal and external ISO audits, assuring compliance to and providing guidance regarding interpreting governmental regulations and ISO 9100 standards, identifying continuous improvement opportunities, preparing required quality documentation, publishing quality metrics and maintaining and updating quality procedures.

Key Responsibilities:

  1. Develop and maintain manufacturing quality plans for the facility, including inspection and control plans, and ensure adherence to and the proper execution of.

  2. Develop and maintain project-specific quality plans, including establishing quality requirements and standards for projects, while adhering to the customer requirements and working as part of a cross-functional team. Measure and publish project-quality costs.

  3. Compile and analyze statistical data in order to assess process capabilities and control processes and conduct Process Failure Mode Effects and Analysis (PFMEA), Gauge Repeatability and Reproducibility (GR&R) and Statistical Process Control (SPC) studies.

  4. Investigate and resolve all assigned Corrective and Preventative Actions (CAPAs).

  5. Perform both internal ISO audits and external supplier audits. Participate in the supplier certification process and develop qualification requirements for purchased components and services.

  6. Assure compliance to and provide guidance and expertise regarding interpreting governmental regulations, ISO AS9100 standards and internal Quality policies in order to assure compliance.

  7. Identify continuous improvement opportunities and support efforts in order to implement LEAN principles throughout the organization.

  8. Prepare required quality documentation and reports. Publish and distribute quality metrics.

  9. Maintain and update quality procedures.

  10. Other duties as assigned.

Salary Range for this position - depending upon skills and experience - $64k - $110k

, Qualifications

Required Qualifications:

  • Bachelor's degree in Manufacturing Engineering or related field.
  • Minimum three years relevant experience.
  • Experience developing manufacturing quality plans.
  • Experience conducting process capability, GR&R, PFMEA and SPC studies.
  • Experience optimizing processes to achieve ongoing cost reductions.
  • Experience working in an ISO environment, preferably AS9100, and conducting internal and supplier audits.
  • LEAN / Six Sigma training and demonstrated application.
  • Proficient PC skills in a Windows environment.
  • Effective written and verbal communication skills.
  • Strong interpersonal and teamwork skills.
  • Employees must be legally authorized to work in the United States. Verification of employment eligibility will be required at the time of hire. Visa sponsorship is not available for this position.
  • This position is subject to the International Traffic in Arms Regulations (ITAR) which requires U.S. person status. ITAR defines U.S. person as an U.S. Citizen, U.S. Permanent Resident (i.e. 'Green Card Holder'), Political Asylee, or Refugee.

Preferred Qualifications:

  • Experience in a precision machine shop environment.
  • Experience working within a CAPA program.
  • Demonstrated use of structured problem-solving methods (i.e. 8D).
  • Experience using an ERP system.
, About Us

Howmet Aerospace Inc. (NYSE: HWM), headquartered in Pittsburgh, Pennsylvania, is a leading global provider of advanced engineered solutions for the aerospace and transportation industries. Our primary businesses focus on jet engine components, aerospace fastening systems, titanium structural parts and forged wheels. With $8.3 Billion in revenue in 2025, our products play a crucial role in enabling fuel efficiency and lightweighting, contributing to our customers' success and making a positive impact on the world. To learn more about the way Howmet Aerospace Inc. is advancing the sustainability of our customers, markets, and communities where we operate, review the 2025 Environmental Social and Governance report at www.howmet.com/esg-report. Follow: LinkedIn, Twitter, Instagram, Facebook, and YouTube.

Equal Opportunity Employer:

Howmet is proud to be an Equal Employment Opportunity employer. We are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other applicable legally protected characteristics.

If you need assistance to complete your application due to a disability, please email TalentAcquisitionCoE_Howmet@howmet.com


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About Howmet Aerospace

Sourced by ZipRecruiter

Howmet Aerospace Inc. (NYSE: HWM), headquartered in Pittsburgh, Pennsylvania, is a leading global provider of advanced engineered solutions for the aerospace and transportation industries. The Company's sales for 2021 approximated $5 billion. The Company's primary businesses focus on jet engine components, aerospace fastening systems, titanium structural parts and forged wheels. With nearly 1,150 granted and pending patents, the Company's differentiated technologies promote more fuel efficiency for aircraft and commercial transportation. Howmet is proud to be an Equal Employment Opportunity and Affirmative Action employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

Industry

Aviation

Company size

10,000+ Employees

Headquarters location

Pittsburgh, PA, US

Year founded

1888