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Iso 11607 Jobs in Arizona (NOW HIRING)

Spartech

Quality Engineer (REQ866)

Goodyear, AZ · On-site

$69K - $90K/yr

Responsible for site certification of ISO 9001 quality system. * Coordinates Quality audits with our cooperate ISO staff and customer audits. * Oversees manufacturing-related processes, insuring they ...

Integrated Magnetics

Quality Engineer

Tucson, AZ · On-site

$70 - $90/hr

Knowledge of quality management systems (QMS), such as ISO 9001 and/or AS9100 * Strong analytical and problem-solving skills. * Proficiency with quality tools and methodologies (e.g., Six Sigma, Root ...

Integrated Magnetics

Quality Engineer

Tucson, AZ · On-site

$61K - $80K/yr

Knowledge of quality management systems (QMS), such as ISO 9001 and/or AS9100 * Strong analytical and problem-solving skills. * Proficiency with quality tools and methodologies (e.g., Six Sigma, Root ...

Integrated Magnetics

Quality Engineer

Tucson, AZ · On-site

$61K - $80K/yr

Knowledge of quality management systems (QMS), such as ISO 9001 and/or AS9100 * Strong analytical and problem-solving skills. * Proficiency with quality tools and methodologies (e.g., Six Sigma, Root ...

Edmund Optics

Quality Engineer II

Tucson, AZ · On-site

$61K - $80K/yr

Maintain and improve elements of the Quality Management System in accordance with ISO 9001, ISO 14001, AS9100, ISO13485, and other applicable standards. * Support internal and external audits by ...

Edmund Optics

Quality Engineer II

Tucson, AZ · On-site

$61K - $80K/yr

Quality Systems & Compliance Maintain and improve elements of the Quality Management System in accordance with ISO 9001, ISO 14001, AS9100, ISO13485, and other applicable standards. * Support ...

Aerotek

Quality Manager

Mesa, AZ · On-site

Ensure ongoing compliance with ISO 9001 standards and regulatory requirements. * Develop and implement quality policies, procedures, and best practices. * Drive continuous improvement initiatives ...

Edmund Optics

Quality Engineer II

Tucson, AZ · On-site

$61K - $80K/yr

Maintain and improve elements of the Quality Management System in accordance with ISO 9001, ISO 14001, AS9100, ISO13485, and other applicable standards. * Support internal and external audits by ...

Smardt

Quality Inspector

Phoenix, AZ · On-site

Support internal and external ISO quality audits, including preparation of documentation and inspection records. * Participate in quality improvement initiatives to enhance manufacturing processes ...

KBR

Quality Manager (Contingency)

Phoenix, AZ · On-site

Completion of ISO 9001, AS9100, ISO17025 QMS auditor training. * Experience with Aerospace manufacturing, ISO17025, and asset management programs. KBR Benefits KBR offers a selection of competitive ...

KBR, Inc.

Quality Manager (Contingency)

Phoenix, AZ · On-site

Completion of ISO 9001, AS9100, ISO17025 QMS auditor training. * Experience with Aerospace manufacturing, ISO17025, and asset management programs. KBR Benefits KBR offers a selection of competitive ...

Smardt

Quality Inspector

Phoenix, AZ · On-site

Support internal and external ISO quality audits, including preparation of documentation and inspection records. * Participate in quality improvement initiatives to enhance manufacturing processes ...

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All JobsIso 11607 JobsIso 11607 Jobs in Arizona

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 Arizona?

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

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

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

Iso 11607 jobs near you

Quality Engineer (REQ866)

Spartech

Goodyear, AZ • On-site

$69K - $90K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 28 days ago

Spartech rating

5.8

Company rating: 5.8 out of 10

Based on 18 frontline employees who took The Breakroom Quiz

72nd of 84 rated plastic manufacturers

Job description

Quality Engineer
Goodyear, AZ
How can you make a difference at your job and can have the opportunity to grow?
Join the Goodyear - Spartech Team! The Goodyear, AZ team manufactures products for defense and commercial aerospace applications, with it's roots going back to WWII. Premium optical acrylic sheet is used primarily in high performance aerospace applications like fighter jet canopies and aircraft windows. Our employees take pride in our superior product, performance, and quality, which are known and valued around the world.
MAIN DUTIES & RESPONSIBILITIES
  • Responsible for site certification of ISO 9001 quality system.
  • Coordinates Quality audits with our cooperate ISO staff and customer audits.
  • Oversees manufacturing-related processes, insuring they are in control and all products produced at the facility meet the requirements of the end-use customer.
  • Ensures that process conditions are monitored and controlled for product consistency and according to the specified conditions.
  • Ensures that products and process changes are in accordance with our company and customer quality requirements.
  • Oversees the testing in accordance with Spartech Lab Performance Policy and applicable Mil-Specifications so that all product grading is accomplished in a timely and accurate manner.
  • Represents the plant and Spartech in all aspects of professional dealings with customers, the technology community, and the commercial group.
  • Resolves and communicates on customer complaints and oversees technical and quality questions from internal and external sources.
  • Coordinates investigation and corrective action on all plant-related customer complaints.
  • Uses Lean/Six Sigma, FMEA, and 5S tools to drive continuous improvement across our business.
  • Assesses quality training needs and provides training to all site employees.
  • Aware of EHS policies and support.
  • Other duties as assigned.

Requirements
Education & Experience
  • Bachelor's Degree or related experience.
  • Minimum 5-7 years' quality management experience in a manufacturing environment.
  • Minimum 5-7 years' managing direct reports.
  • Experience working with Cross Functional teams.
  • Experience with managing EHS procedures.
  • Good computer skills with Microsoft, SAP experience a plus.
  • Good problem-solving skills.

Benefits
We offer competitive salary, incentive, and benefit programs. Most Benefits Start Day ONE!
Benefits include:
  • Medical, Dental, & Vision.
  • Company paid life and long-term and short-term disability programs.
  • Flexible spending accounts.
  • 401(k) with a strong matching program.
  • 120 hours Paid Time Off (pro-rated based on hire date).
  • 11 paid holidays.

Spartech, LLC headquartered in Maryland Heights, Missouri is a leading manufacturing organization in the Custom Sheet & Roll Stock and Packaging markets with over a dozen locations throughout the United States. We have a broad customer base with extensive product offerings and technologies. Many of our materials are used in products you might see every day- for example if you start your morning with a single serve yogurt, the container you ate from may be made from one of Spartech's products or the refrigerator where the yogurt was stored could have Spartech products in its interior features. More unique uses of our products can be seen in military or security applications for example in fighter jet canopies or bullet resistant windows. From routine daily-life to life-saving applications-we make a difference. Our broad scope of products and services keep our environment interesting and challenging with a culture focused on success.
Spartech, LLC provides equal employment opportunity to all qualified applicants regardless of race, color, religion, national origin, sex, sexual orientation, gender identity, age, disability, genetic information, or veteran status, or other legally protected classification in the state in which a person is seeking employment. Spartech will use E-Verify to ensure employment eligibility of newly hired employees where required.

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