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 ...
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 ...
Quality Manager
Fort Wayne, IN · On-site
ISO Compliance & Audits: Maintain the Quality Management System (QMS) for compliance with ISO 9001 and 14001 standards. Support all internal and third-party ISO audits. * Continuous Improvement:
Quality Manager
Fort Wayne, IN · On-site
ISO Compliance & Audits: Maintain the Quality Management System (QMS) for compliance with ISO 9001 and 14001 standards. Support all internal and third-party ISO audits. * Continuous Improvement:
Quality Assurance Specialist
New Paris, IN · On-site
$23 - $25/hr
New employee training on quality as needed. * Assist in maintaining ISO 9001-2015 quality documentation. * Perform internal audits as directed. * Assist as necessary maintaining internal corrective ...
Quality Assurance Specialist
New Paris, IN · On-site
$23 - $25/hr
New employee training on quality as needed. * Assist in maintaining ISO 9001-2015 quality documentation. * Perform internal audits as directed. * Assist as necessary maintaining internal corrective ...
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 ...
Quick apply
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 ...
ISO Compliance & Audits: Maintain the Quality Management System (QMS) for compliance with ISO 9001 and 14001 standards. Support all internal and third-party ISO audits. * Continuous Improvement:
ISO Compliance & Audits: Maintain the Quality Management System (QMS) for compliance with ISO 9001 and 14001 standards. Support all internal and third-party ISO audits. * Continuous Improvement:
Quality Assurance Specialist
New Paris, IN · On-site
$23 - $25/hr
New employee training on quality as needed. * Assist in maintaining ISO 9001-2015 quality documentation. * Perform internal audits as directed. * Assist as necessary maintaining internal corrective ...
Quality Assurance Specialist
New Paris, IN · On-site
$23 - $25/hr
New employee training on quality as needed. * Assist in maintaining ISO 9001-2015 quality documentation. * Perform internal audits as directed. * Assist as necessary maintaining internal corrective ...
Supplier Quality Engineer
North Vernon, IN · On-site
ISO 9001 and IATF16949 Current StandardsLead Auditor CertifiedGM, Ford and FCA applicable Customer Portals.GD&T Comprehension and Print Reading SkillsInternal/Process AuditsExcellent Communication ...
Quick apply
Supplier Quality Engineer
North Vernon, IN · On-site
ISO 9001 and IATF16949 Current StandardsLead Auditor CertifiedGM, Ford and FCA applicable Customer Portals.GD&T Comprehension and Print Reading SkillsInternal/Process AuditsExcellent Communication ...
Supplier Quality Engineer
North Vernon, IN · On-site
Understanding of ISO 9001 &IATF 16949 preferred. Knowledge/Experience preferred: * Experience with automotive part approval process. * ISO 9001 and IATF16949 Current Standards * Lead Auditor ...
Supplier Quality Engineer
North Vernon, IN · On-site
Understanding of ISO 9001 &IATF 16949 preferred. Knowledge/Experience preferred: * Experience with automotive part approval process. * ISO 9001 and IATF16949 Current Standards * Lead Auditor ...
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 ...
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 ...
QUALITY MANAGER
Gary, IN · On-site
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 ...
QUALITY MANAGER
Gary, IN · On-site
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 ...
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 ...
Quality and Safety Lead
$38 - $46/hr
This is a part-time role with the potential to convert to full-time as the company grows and advances toward ISO (International Organization for Standardization) certification. In Year One, the ...
Quick apply
Quality and Safety Lead
$38 - $46/hr
This is a part-time role with the potential to convert to full-time as the company grows and advances toward ISO (International Organization for Standardization) certification. In Year One, the ...
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 ...
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 ...
Participate in internal and external audits including ISO and IATF, supporting preparation, execution, and follow-up actions * Support supplier audits to improve compliance and operational ...
Quick apply
Participate in internal and external audits including ISO and IATF, supporting preparation, execution, and follow-up actions * Support supplier audits to improve compliance and operational ...
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 ...
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 ...
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 ...
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 ...
Program Quality Engineer
Fort Wayne, IN · On-site
$29 - $31/hr
Support compliance with AS9100, ISO 9001, IATF 16949, CMMI, and other applicable standards. * Monitor and report quality performance metrics and drive continuous improvement initiatives.
Program Quality Engineer
Fort Wayne, IN · On-site
$29 - $31/hr
Support compliance with AS9100, ISO 9001, IATF 16949, CMMI, and other applicable standards. * Monitor and report quality performance metrics and drive continuous improvement initiatives.
Iso 11607 information
What is the difference between Iso 11607 vs Packaging Technician?
| Aspect | Iso 11607 | Packaging Technician |
|---|---|---|
| Certifications | Standards for sterile packaging | Often certified in packaging processes |
| Work Environment | Manufacturing and sterile packaging facilities | Packaging lines, production areas |
| Industry Usage | Medical device and pharmaceutical packaging | Medical device, pharmaceutical, and consumer goods |
| Primary Focus | Ensuring packaging meets sterilization and safety standards | Assembling, 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?
What is ISO 11607?
What skills and qualifications are needed to work with ISO 11607?

$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
- 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
- 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
- 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
- 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
- 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.