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Iso 11607 Jobs in Arizona (NOW HIRING)

This role ensures continued compliance to ISO 13485 and ISO 9001 standards, supports validation and transfer activities, and maintains product quality and customer confidence during a critical ...

QA/QC Engineer II

Phoenix, AZ

$71K - $92K/yr

Implement QA/QC activities according to the requirements of 21 CFR 820, ISO 13485:2016, and CE mark during design, manufacturing, and product fulfillment process. * Perform incoming inspections ...

QA/QC Engineer II

Phoenix, AZ · On-site

$71K - $92K/yr

Implement QA/QC activities according to the requirements of 21 CFR 820, ISO 13485:2016, and CE mark during design, manufacturing, and product fulfillment process. * Perform incoming inspections ...

Quality Engineer II

Tucson, AZ · On-site

$61K - $80K/yr

Develop and implement risk management strategies in accordance with ISO 14971 and maintain risk files throughout product lifecycle. * Provide input on process validation and sterilization validation ...

Quality Engineer II

Tucson, AZ · On-site

$61K - $80K/yr

Develop and implement risk management strategies in accordance with ISO 14971 and maintain risk files throughout product lifecycle. * Provide input on process validation and sterilization validation ...

Quality Engineer

Scottsdale, AZ · On-site

$70K - $90K/yr

The Quality Engineer will ensure compliance to required standards including FDA and ISO during process development and the manufacturing of medical device components. In addition, this person will ...

Quality Engineer

Scottsdale, AZ · On-site

$72K - $93K/yr

The Quality Engineer will ensure compliance to required standards including FDA and ISO during process development and the manufacturing of medical device components. In addition, this person will ...

Quality Engineer

Scottsdale, AZ · On-site

$70K - $90K/yr

The Quality Engineer will ensure compliance to required standards including FDA and ISO during process development and the manufacturing of medical device components. In addition, this person will ...

Senior Engineer I - Quality

Chandler, AZ · On-site

$87K - $118K/yr

Perform Internal Audits for worldwide locations based on ISO 9001, IATF 16949, AS9100, ISO 14001, ISO 21434, IEC 62443 etc. * Assist with 3rd party QMS certifications and on-going 3rd-party audits at ...

Senior Engineer I - Quality

Chandler, AZ · On-site

$87K - $118K/yr

Perform Internal Audits for worldwide locations based on ISO 9001, IATF 16949, AS9100, ISO 14001, ISO 21434, IEC 62443 etc. * Assist with 3rd party QMS certifications and on-going 3rd-party audits at ...

Quality Manager

Mesa, AZ · On-site

$100K - $120K/yr

Develop, maintain, and enforce quality systems, policies, and procedures to ensure compliance with company standards, customer specifications, and applicable regulations (e.g., ISO, AS9100, FDA, etc.

Develop, maintain, and enforce quality systems, policies, and procedures to ensure compliance with company standards, customer specifications, and applicable regulations (e.g., ISO, AS9100, FDA, etc.

Develop, maintain, and enforce quality systems, policies, and procedures to ensure compliance with company standards, customer specifications, and applicable regulations (e.g., ISO, AS9100, FDA, etc.

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Showing results 1-20

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

Quality Assurance Specialist ISO/IEC 17025

Field Calibrations, Inc.

Phoenix, AZ • On-site

$22 - $28/hr

Full-time

Medical, Dental, Vision, Life, PTO

Posted 14 days ago


Job description

Benefits:
  • Applied AI training program
  • AD&D Insurance
  • Life Insurance
  • Paid Holidays
  • Health insurance
  • Paid time off

JOB TITLE
Quality Assurance Specialist (ISO/IEC 17025)
LOCATION
Phoenix, AZ · On-site
COMPENSATION
$22.00 – $28.00 per hour, depending on experience ($45,760 – $58,240 annualized). Full benefits package described below. Non-exempt, overtime eligible.
ABOUT FIELD CALIBRATIONS
Field Calibrations, Inc. is a Phoenix-based, ISO/IEC 17025:2017-accredited calibration laboratory serving aerospace, defense, manufacturing, energy, and research clients across the United States. We provide precision calibration and repair services on electrical, pressure, temperature, dimensional, torque, mass, and RF/microwave standards, both in our Phoenix lab and at client sites. We are a Service-Disabled Veteran-Owned Small Business (SDVOSB) pursuing SBA 8(a) certification, and we operate under a strict Applied AI-augmented quality management system that pairs experienced metrologists with modern data tools.
ABOUT THE ROLE
The Quality Assurance Specialist supports the Quality Assurance Manager in maintaining Field Calibrations' ISO/IEC 17025:2017 quality management system. This role owns the day-to-day execution of controlled-document management, corrective and preventive action (CAPA) tracking, internal audit coordination, calibration record review, and customer complaint intake. Reports to the Quality Assurance Manager.
WHAT YOU WILL DO
Document Control (ISO/IEC 17025 § 8.3)
• Maintain the controlled-document library including calibration procedures, work instructions, quality manual, and form templates
• Process document change requests, route for approval, publish approved versions, and retire superseded revisions
• Maintain the master document list, revision history, and technician acknowledgment records
Corrective and Preventive Action (§ 8.7)
• Log nonconformities, customer complaints, and internal-audit findings in the CAPA register
• Track root-cause analyses to closure, verify effectiveness of corrective actions, and escalate overdue items to the QA Manager
• Prepare monthly CAPA metrics for the QA Manager and Laboratory Manager
Internal Audits (§ 8.8)
• Coordinate the annual internal audit calendar, assist with audit preparation, and observe audit sessions
• Draft audit reports for QA Manager review, distribute findings to auditees, and track corrective actions
Calibration Record Review
• Review completed calibration certificates and worksheets for completeness, correct traceability language, uncertainty statement accuracy, and technician sign-off
• Sample-audit archived records against the retention schedule
• Coordinate with the Laboratory Manager on records that require re-issuance or supplemental data
Customer Complaints and Satisfaction (§ 7.9)
• Serve as the intake point for customer complaints; log, categorize, and route to the QA Manager for disposition
• Coordinate customer-satisfaction surveys and summarize trends for QA Manager quarterly reporting
A2LA / ANAB Assessment Support
• Assist the QA Manager in preparing for the annual accreditation assessment
• Track assessment findings to closure and coordinate the response package
Applied AI Program Participation
• Participate in the Field Calibrations Applied AI training program, applied to quality-system workflows including CAPA trending, complaint analysis, and audit-evidence organization
WHAT WE ARE LOOKING FOR
Required
• High school diploma or GED; associate or bachelor's degree in quality, engineering, science, or a related field preferred
• 2+ years experience in a quality assurance, document control, or regulated-industry administrative role
• Working knowledge of ISO/IEC 17025:2017 or a comparable quality standard (ISO 9001:2015, AS9100, IATF 16949)
• Meticulous attention to detail and strong organizational skills
• Proficient with Microsoft 365 (Word, Excel, SharePoint, OneDrive)
• Ability to read and interpret calibration certificates and technical procedures
• Excellent written communication skills
Preferred
• Prior experience in an ISO/IEC 17025 calibration laboratory or aerospace/defense-regulated environment
• ASQ CQA (Certified Quality Auditor) or CQPA (Certified Quality Process Analyst) credential or candidate
• Experience with an eQMS platform (MasterControl, Qualio, Greenlight Guru, ETQ, or similar)
• Familiarity with the Applied AI-augmented QMS workflow
• Prior participation in an IAS, A2LA or ANAB accreditation assessment as an auditee or observer
WHAT WE OFFER
Compensation
• $22.00 – $28.00 per hour ($45,760 – $58,240 annualized), based on demonstrated experience
• Non-exempt; overtime eligible at 1.5× regular rate
• Discretionary annual performance bonus
Health Insurance
• Blue Cross Blue Shield of Arizona (BCBSAZ) EveryDay PPO plan
• 100% employer-paid employee-only medical premium
• Effective the first of the month following 90 days of employment
• Dependent/family coverage available at employee cost (dental and vision under evaluation for later this year)
Life & AD&D Insurance
• $25,000 basic life and AD&D coverage
• 100% employer-paid
Combined Paid Time Off (accrues from day 1, usable after day 91)
• 10 days per year (0–1 years of service)
• 12 days per year (1–2 years)
• 13 days per year (2–3 years)
• 14 days per year (3–4 years)
• 15 days per year (4–5 years)
• 16 days per year (5–6 years)
• 17 days per year (6–7 years)
• 18 days per year (7–8 years)
• 19 days per year (8–9 years)
• 20 days per year (9–10 years)
• 25 days per year (10+ years)
• Combined PTO bank absorbs vacation, sick, and bereavement leave into a single benefit. Materially exceeds Arizona statutory sick-leave minimum under A.R.S. § 23-371. Up to 40 hours of protected sick time carries over year-to-year.
Paid Holidays (11 per year)
• New Year's Day, Martin Luther King Jr. Day, Presidents' Day, Memorial Day, Independence Day, Labor Day, Veterans Day, Thanksgiving Day, Day after Thanksgiving, Christmas Eve (half day), and Christmas Day
Professional Development
• Unlimited employer reimbursement for pre-approved certification courses (ASQ CQA, CQPA, ISO/IEC 17025 lead auditor, and other quality credentials)
• Participation in the Field Calibrations Applied AI training program
• Career path toward Quality Assurance Manager and other quality-leadership positions
Tools & Equipment
• All required computing equipment, licenses, and quality-system tooling provided by the Company
Culture
• Culture of technical excellence, respect for the craft of metrology, and calm, professional operations
• Veteran-friendly workplace led by a former military PMEL professional
HOW TO APPLY
Submit your application through our CareerPlug portal. Include your resume and a brief cover statement describing your quality-system experience and the standards you have worked under. Interviews will be conducted in person at our Phoenix laboratory.
Field Calibrations, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Field Calibrations is an E-Verify employer, participating pursuant to A.R.S. § 23-214.
Employment is at-will. This posting is not a contract of employment.