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Iso 11607 Jobs in Michigan (NOW HIRING)

VAYAN GROUP, LLC

Be Seen First

Quality Team Leader

Lansing, MI · On-site

$17 - $18/hr

This role monitors inspection workflow, evaluates team performance, supports compliance to ISO 9001 and IATF 16949 standards , and ensures proper control of non-conforming, rejected, and scrap ...

Basin

Quality Inspector

Sturgis, MI · On-site

Maintain ISO standards and train others to ISO standards. Other Duties * Clear and immediate communication to appropriate personnel of necessary concerns related to product development and production ...

Basin Holdings

Quality Inspector

Sturgis, MI · On-site

Maintain ISO standards and train others to ISO standards. Other Duties * Clear and immediate communication to appropriate personnel of necessary concerns related to product development and production ...

Centracore LLC

Quality Engineer

Saint Clair, MI · On-site

$68K - $88K/yr

This role will be involved in maintaining and improving compliance with AS9100, IATF 16949, ISO 14001, and ITAR requirements, while contributing to continuous improvement initiatives and other ...

Attalon, Inc.

Manufacturing Engineer

Traverse City, MI · On-site

$65K - $125K/yr

The site encompasses 40,000 sq. ft., including 15,000 sq. ft. of ISO 7 and ISO 8 cleanrooms certified to ISO 14644‑1:2015, enabling both high‑volume production and rapid prototyping in a ...

Amrize

Quality Manager

Saginaw, MI · On-site

Develop, maintain, and improve the company Quality Management System in accordance with ISO 9001 requirements. * Maintain documented procedures, work instructions, quality records, and process ...

SUR-SEAL LLC

Quality Engineer

Grand Rapids, MI · On-site

$80K - $100K/yr

The QE also represents Sur-Seal in customer and ISO audits, supporting the efforts of the Director of Quality. JOB DUTIES AND RESPONSIBILITIES: * Analysis o Perform root cause analysis, and develop ...

Deepview Corp.

Be Seen First

Automotive Quality Engineer - Tier 1 Manufacturing

Plymouth, MI · On-site

$85K - $91K/yr

Support compliance with IATF 16949, ISO 9001, AIAG requirements, and customer-specific requirements . * Conduct process audits and product audits to ensure manufacturing standards are being followed.

Attalon, Inc.

Manufacturing Engineer

Traverse City, MI · On-site

$65K - $125K/yr

The site encompasses 40,000 sq. ft., including 15,000 sq. ft. of ISO 7 and ISO 8 cleanrooms certified to ISO 14644‑1:2015, enabling both high‑volume production and rapid prototyping in a ...

SUR-SEAL LLC

Quality Engineer

Grand Rapids, MI

$69K - $89K/yr

The QE also represents Sur-Seal in customer and ISO audits, supporting the efforts of the Director of Quality. JOB DUTIES AND RESPONSIBILITIES: * Analysis o Perform root cause analysis, and develop ...

Amrize

Quality Manager

Saginaw, MI · On-site

Develop, maintain, and improve the company Quality Management System in accordance with ISO 9001 requirements. * Maintain documented procedures, work instructions, quality records, and process ...

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Showing results 41-60

All JobsIso 11607 JobsIso 11607 Jobs in Michigan

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 Michigan?

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

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

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

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Cities in Michigan with the most Iso 11607 job openings:

Iso 11607 jobs near you

Quality Manager

Total Security Solutions Inc.

Fowlerville, MI • On-site

$120K - $140K/yr

Full-time

Re-posted 23 days ago

Job description

Quality Manager

At Total Security Solutions (TSS), our purpose is simple: we protect lives and property. We design, manufacture, and install custom, high-end bulletproof barrier systems that balance maximum security with flawless aesthetics.

Because the stakes are high, we take precision seriously. We are hiring our first-ever Quality Manager, and we need a hands-on builder who is excited to establish a world-class system from the ground up. If you prefer building a proactive culture over just maintaining someone else's legacy paperwork, this role is for you.

The Opportunity

As our first Quality Manager, you won’t be stepping into a pre-baked routine. You will own the entire quality ecosystem across all TSS facilities. You will have a blank canvas to build, scale, and continuously improve an ISO 9000-compliant system, shifting our manufacturing environment from reactive quality control to true proactive prevention.

What the Role Involves

In this role, you will establish and maintain our ISO 9000-compliant Quality Management System from scratch, including all standardized policies, procedures, and internal audit programs. You will embed common quality tools across the organization, guiding production teams away from fixing mistakes and toward continuous improvement.

You will also oversee testing programs for incoming materials, in-process production, and finished architectural products to guarantee they meet rigorous regulatory standards. When issues do arise, you will own the product lifecycle quality process, managing issue tracking, spearheading deep root-cause analyses, and implementing corrective and preventive actions (CAPA).

Finally, you will serve as the technical quality lead for the executive team. You will track quality and production data, translating trends into clear KPIs and risk reports for leadership, while managing the technical documentation and engineering drawings that ensure consistency across our product lines.

What We Are Looking For

We are looking for someone with a Bachelor’s degree in Engineering, Industrial Design, or a related field, alongside 7+ years in quality management, engineering, or manufacturing. Experience in building materials, architectural systems, or safety and security industries will give you a major head start.

You should bring deep, practical knowledge of ISO-based systems and hands-on experience leading New Product Introduction processes, including PPAP, DFMEA, and PFMEA.

Because this role requires cross-functional leadership, you must be a resilient, calm-under-pressure communicator with strong negotiation skills, capable of driving complex projects to completion without needing direct authority over a team. Experience with Lean, Six Sigma, or Kaizen methodologies will be highly valuable as you use data to make informed decisions.

Why Join TSS?

Over the next decade, we are positioned for significant growth. By stepping into this role today, you will be the primary architect of the operational standards that support our scaling business. We offer a competitive package—including standard corporate benefits like tuition reimbursement—and a profit-sharing bonus structure built around company performance.

Ready to build a quality culture that truly matters? Apply today to start the conversation.

Apply