ZipRecruiter

Log In

1

Iso 11607 Jobs in Indiana (NOW HIRING)

Commercial Vehicle Group

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 ...

Commercial Vehicle Group

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 ...

EXOS

Quality Engineer

Indianapolis, IN · On-site

$68K - $88K/yr

Ensure compliance with IATF 16949, ISO 9001, and customer-specific requirements Process & Product Quality * Monitor manufacturing processes to ensure consistent product quality * Conduct root cause ...

PSG

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 ...

Detroit Engineered Products

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 ...

eShocan

Plant QMS/PMT Engineer

Warsaw, IN · On-site

$60K - $78K/yr

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

Voyant Beauty

Engineer, Quality

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 ...

OrthoPediatrics

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 ...

voyant

Engineer, Quality

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 ...

Voyant Beauty

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 ...

voyant

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 ...

next page

Showing results 1-20

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
Supplier Quality Engineer

Supplier Quality Engineer

Martinrea International Inc.

North Vernon, IN • On-site

Full-time

Posted 26 days ago

Martinrea International rating

6.8

Company rating: 6.8 out of 10

Based on 32 frontline employees who took The Breakroom Quiz

324th of 430 rated machine equipment manufacturers

Job description

Job Summary: The Supplier Quality Engineer is responsible for assisting with implementing, monitoring, and approving controls for supplier parts. They are responsible for communication between the organization and its suppliers in regards to product defect tracking and problem resolution. The Supplier Quality Engineer assists the Supply Chain Manager in conducting supplier audits as scheduled.

Required Education and Experience:

  • College degree in a technical field or 5 years of experience related to defined job responsibilities or equivalent training.
  • Understanding of ISO 9001 &IATF 16949 preferred.

Knowledge/Experience preferred:

  • Experience with automotive part approval process.
  • ISO 9001 and IATF16949 Current Standards
  • Lead Auditor Certified
  • GM, Ford and FCA applicable Customer Portals.
  • GD&T Comprehension and Print Reading Skills
  • Internal/Process Audits
  • Excellent Communication skills.
  • Microsoft Office Suite and good typing/keyboarding skills.
  • Personal qualifications must include a demonstrated ability to deal effectively with people, good personal grooming and exceptional oral and written communication.

Essential Functions:

  • Leads supplier external audits
  • Read, verify and approve supplier PPAP documentation.
  • Issues, tracks, reviews, follows up and ensures verification of supplier part related issues for closure
  • Work with Suppliers for new launch, production and ongoing development.
  • Comply and conform to all applicable BMS documentation to ensure compliance with ISO 9001 & IATF 16949 and Customer Specific Requirements.
  • Access Martinrea Central for score card tracking.
  • Oversee hourly employee(s) in supporting roles. E.g. Quality Inspector (Receiving).

Work Environment:

  • Both office setting and production environment
  • Constant communication with employees, peers, management and suppliers.
  • Flexible hours as required
  • Some Travel Required

Physical Demands:

  • Ability to work on computer for long periods of time

Health and Safety:

  • Must work in accordance with Health and Safety regulations, Company and plant rules, policies and procedures
  • Must use or wear Personal Protective Equipment and certain clothing as required by the Company
  •  

Other Duties:

  • As temporarily assigned.

Disclaimer:

  • This job description does not constitute a contract of employment. The Company may exercise its employment at will rights at any time

What Martinrea International employees say

Pay

Benefits

Hours and flexibility

Workplace

Get the full story on Breakroom