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Iso 11607 Jobs in Indiana (NOW HIRING)

Ametek

Manufacturing Engineer

Pierceton, IN · On-site

$67K - $87K/yr

Develop and monitor compliance within department to meet internal procedures, ISO and FDA regulations * Effectively and proactively perform continuous improvement on existing processes. * Lead ...

CONTINENTAL International Inc

Be Seen First

Quality Manager

Fort Wayne, IN · On-site

$75K - $85K/yr

Maintain ISO 9001:2015 Certification compliance * Oversee supplier communication and quality assurance standards * Supervise daily receiving, inspection, and sub-assembly departments Qualifications ...

Jupiter Aluminum

Regional Quality Manager

Fairland, IN · On-site

This role ensures full compliance with ISO 9001, ASTM standards, customer specifications, and applicable regulatory requirements, while safeguarding the integrity and performance of coated aluminum ...

GSMW, Inc.

Quality Manager

South Bend, IN · On-site

Coordinating with ISO registrar to plan and schedule certification and surveillance audits, and travelling to other GSM facilities when such audits are conducted * Ensuring that ISO/TS documentation ...

Ametek

Manufacturing Engineer

Pierceton, IN · On-site

$67K - $87K/yr

Develop and monitor compliance within department to meet internal procedures, ISO and FDA regulations * Effectively and proactively perform continuous improvement on existing processes. * Lead ...

Ambu

Quality Engineer

Noblesville, IN · On-site

$67K - $87K/yr

The ideal candidate must have hands-on experience with design controls and risk management, including FMEA and structured problem-solving methodologies, and a solid understanding of ISO 13485, 21 CFR ...

CONTINENTAL International Inc

Be Seen First

Quality Manager

Fort Wayne, IN · On-site

$75K - $85K/yr

Maintain ISO 9001:2015 Certification compliance * Oversee supplier communication and quality assurance standards * Supervise daily receiving, inspection, and sub-assembly departments Qualifications ...

Hansen Corporation

Quality Engineer Lead

Princeton, IN · On-site

$67K - $87K/yr

Description Hansen Corporation DBA ElectroCraft. is seeking a Quality Engineer in Princeton, IN who will be primarily responsible for implementing audits to ensure continued retention of ISO ...

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All JobsIso 11607 JobsIso 11607 Jobs in Indiana

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 are the main challenges faced by professionals working with ISO 11607 compliance in medical device packaging?

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 are the key skills and qualifications needed to thrive as an ISO 11607 Compliance Specialist, and why are they important?

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:
What job categories do people searching Iso 11607 jobs in Indiana look for? The top searched job categories for Iso 11607 jobs in Indiana are:
Iso 11607 jobs near you
Program Quality Engineer

Program Quality Engineer

Indotronix International Corporation

Fort Wayne, IN • On-site

$29 - $31/hr

Full-time

Re-posted 9 days ago

Job description

Program Quality Engineer | Fort Wayne, Indiana, United States
Indotronix is seeking an :Program Quality Engineer
Location:Fort Wayne, IN
Shift: 1st Shift (Mon-Fri) 7:00 AM to 3:00 PM
Work Schedule: 4/40
Bachelor's Degree in a Technical Field of Study
Key Responsibilities
  • Develop and maintain program quality plans, including schedules, resources, budgets, and quality deliverables.
  • Collaborate with cross-functional teams to support APQP planning and product quality objectives.
  • Support lifecycle management activities, phase-gate reviews, and program reviews.
  • Serve as the primary customer quality contact for inspections, audits, PPAP submissions, and quality issue resolution.
  • Ensure quality requirements are communicated and implemented across design, suppliers, subcontractors, and manufacturing teams.
  • Lead nonconformance management, root cause analysis, and corrective action activities.
  • Identify quality risks and implement mitigation strategies to minimize program impact.
  • Review and approve supplier quality plans, subcontractor quality requirements, and statements of work.
  • Support compliance with AS9100, ISO 9001, IATF 16949, CMMI, and other applicable standards.
  • Monitor and report quality performance metrics and drive continuous improvement initiatives.
  • Participate in customer audits, internal audits, and production readiness activities.

Required Qualifications
  • Strong knowledge of quality management systems and industry standards such as AS9100, ISO 9001, and CMMI.
  • Experience leading Root Cause Corrective Action (RCCA) investigations and problem-solving activities.
  • Strong analytical, problem-solving, and risk management skills.
  • Familiarity with Lifecycle Management (LCM) processes and project/program management.
  • Ability to build and maintain strong customer relationships.
  • Strong leadership, business acumen, and cross-functional collaboration skills.
  • Excellent verbal and written communication skills.

Preferred Qualifications
  • Experience with quality tools and methodologies such as 8D, Lean Six Sigma, and continuous improvement practices.
  • Experience with AS9145 Advanced Product Quality Planning (APQP).
  • Experience in aerospace, defense, manufacturing, or other regulated industries.

Education & Experience
Required Education
  • Bachelor's degree in a technical field.
  • Bachelor's degree in Engineering
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About Indotronix

Sourced by ZipRecruiter

In 1986, Indotronix established itself in the staffing space. 22 years later, Avani entered the scene, offering consulting and technology development. Finally, in 2016, the two joined forces to begin delivering talent across all areas, from Staffing to Consulting to unique platform development.

Industry

Recruiting and staffing services

Company size

1,001 - 5,000 Employees

Headquarters location

Rochester, NY, US

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