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Iso 11607 Jobs in Indiana (NOW HIRING)

Quality Engineer

Avon, IN · On-site

$70K - $90K/yr

Support and maintain compliance with ISO 13485, FDA QSR, and applicable medical device regulatory requirements. * Assist with internal audits, supplier audits, customer audits, and third-party ...

Quality Engineer

Michigan City, IN · On-site

$70K - $90K/yr

Position Summary The Quality Engineer is a hands-on technical leader responsible for driving permanent corrective actions, sustaining compliance to IATF 16949, ISO 9001, and ISO 14001 standards, and ...

Quality Engineer

Michigan City, IN · On-site

$70K - $90K/yr

Position Summary The Quality Engineer is a hands-on technical leader responsible for driving permanent corrective actions, sustaining compliance to IATF 16949, ISO 9001, and ISO 14001 standards, and ...

Lead and prepare the facility for ISO 9001, BRC, and other regulatory or customer audits * Maintain accuracy and calibration of production, testing, and analytical equipment * Manage the Quality Hold ...

Manufacturing Engineer

Fort Wayne, IN · On-site

$72K - $92K/yr

Lead new product projects as project manager, ensuring quality, on-time delivery, and compliance with ISO, FDA, and customer specifications. * Create and manage Device Master Records (DMR ...

Plant QMS/PMT Engineer

Warsaw, IN · On-site

$69K - $89K/yr

Lead auditing and certification activities for ISO and IATF for client * Assist in auditing activities at supplier as required to support the success of the organization * Monitor and report on the ...

Quality Engineer

Elkhart, IN · On-site

$69K - $89K/yr

Provide support during customer audits, internal audits, and external certification reviews (FDA, ISO, etc.). * Lead and/or participate in cross-functional improvement initiatives, such as changeover ...

Post Market Quality Engineer

Warsaw, IN · On-site

$69K - $89K/yr

ISO 13485 Audit Certification preferred * 5 years of Medical Device Quality experience preferred. EDUCATION AND/OR EXPERIENCE: Requires a bachelor's degree in an Engineering discipline, or equivalent ...

Quality Engineer

Elkhart, IN · On-site

$69K - $89K/yr

Provide support during customer audits, internal audits, and external certification reviews (FDA, ISO, etc.). * Lead and/or participate in cross-functional improvement initiatives, such as changeover ...

Showing results 21-40

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 Indiana? For Iso 11607 jobs in Indiana, the most frequently searched job titles are:
Infographic showing various Iso 11607 job openings in Indiana as of June 2026, with employment types broken down into 93% Full Time, 3% Part Time, 3% Contract, and 1% Nights. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution.

Quality Manager (Mitsubishi Chemical Advanced Materials)

Mitsubishichemicalgroup

Fort Wayne, IN

$130K - $145K/yr

Full-time

Re-posted 19 days ago


Job description

Company:

Mitsubishi Chemical Advanced Materials Inc.

Job Description:

Are you a quality-driven leader passionate about continuous improvement, customer satisfaction, and operational excellence? We are seeking an experienced Quality Manager to lead the Quality function at our Fort Wayne facility and drive a culture focused on compliance, accountability, and continuous improvement.

This role is responsible for managing the site Quality Management System, ensuring compliance with regulatory and customer requirements, leading quality improvement initiatives, and serving as the key quality contact for customers, audits, and cross-functional operations support.

What You'll DoLead Quality Systems & Compliance
  • Lead and maintain the site Quality Management System (QMS) to ensure compliance with ISO 9001, ISO 13485, ISO 17025, and customer requirements
  • Serve as the primary contact for third-party audits and customer quality audits
  • Manage local audit programs including scheduling, training, reporting, and corrective action follow-up
  • Support compliance activities related to product standards and regulatory requirements
Drive Continuous Improvement
  • Establish and monitor quality KPIs, analyze trends, and report on overall system effectiveness
  • Lead root cause analysis, CAPA initiatives, and continuous improvement projects
  • Support deployment of Lean Six Sigma and continuous improvement methodologies across the site
  • Utilize data-driven decision-making tools to improve quality performance and operational efficiency
Lead Customer Quality Initiatives
  • Serve as the primary quality contact for customer concerns, audits, site visits, complaints, and returns
  • Ensure timely communication and resolution of customer quality issues
  • Collaborate cross-functionally to troubleshoot and resolve quality concerns
  • Support validation processes and customer notifications as required
Lead & Develop Teams
  • Manage and develop the Quality team including staffing, scheduling, training, coaching, and performance management
  • Promote quality awareness and provide training in auditing, quality systems, and problem-solving methodologies
  • Foster strong collaboration across departments to support plant and customer objectives
  • Lead selected Americas quality initiatives and projects requiring cross-functional influence and coordination
What We're Looking For
  • Bachelor's degree in Engineering, Business, or related field
  • 3-10 years of quality management experience in a manufacturing environment
  • 2-5 years of supervisory or team leadership experience
  • Strong knowledge of Quality Management Systems and ISO standards including ISO 9001 and ISO 13485
  • Experience with Root Cause Analysis, CAPA, SPC, Lean Six Sigma, and continuous improvement methodologies
  • ASQ certifications such as CQA, CQM, CQE, or Lead Auditor certifications preferred
  • Lean Six Sigma Black Belt certification preferred
  • Experience with eQMS platforms preferred
  • Strong communication, organizational, and problem-solving skills
  • Ability to influence cross-functional teams and manage multiple priorities in a fast-paced environment
  • Proficiency with Microsoft Office, MRP systems, and Minitab
  • Ability to travel up to 25%, including occasional international travel
Why Join Us
  • Lead quality initiatives in a dynamic manufacturing environment
  • Influence operational excellence and customer satisfaction across the organization
  • Opportunity to drive meaningful process improvements and quality system enhancements
  • Collaborate with cross-functional leadership teams across North America
  • Competitive compensation and comprehensive benefits package

The salary range for this position is $130,000-$145,000. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations may influence base pay offered. This salary will be subject to a geographic adjustment (according to a specific city and state), if an authorization is granted to work outside of the location listed in this posting.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status

Mitsubishi Chemical Advanced Materials Inc. is committed to working with and providing reasonable accommodation to individuals with physical and mental disabilities. If you need special assistance or an accommodation while seeking employment, please email MCA-MBX_accomodations@m-chem.com.We will make a determination on your request for reasonable accommodation on a case-by-case basis.

The law requires Mitsubishi Chemical Advanced Materials Inc. to post a notice describing the Federal laws prohibiting job discrimination. For information regarding your legal rights and protections, please click on the following link: Know Your Rights

Mitsubishi Chemical Advanced Materials Inc. will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay. Please see the Pay Transparency Nondiscrimination Provision for more information

As a Federal Contractor, Mitsubishi Chemical Advanced Materials Inc. is required to participate in the E-Verify Program to confirm eligibility to work in the United States. For information please click on the following link: E-Verify.