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Iso 11607 Jobs in Florida (NOW HIRING)

atrion

Quality Engineering Manager

Davie, FL

... ISO, EU MDR, ANVISA, MHLW, and TGA). General Duties and Responsibilities : * Ensure the ongoing integrity, adequacy, and appropriateness of the Quality Management System and associated processes.

TRACE SYSTEMS

Quality Manager

Tampa, FL

Support for internal and external audits - customer audits, corporate audits, ISO audits, etc. * Provides quality-related training to program leadership and key staff responsible for implementing ...

Germfree Laboratories Inc

Quality Engineer

Ormond Beach, FL · On-site

$63K - $81K/yr

ISO 14644; EU GMP Annex 1; USP / ; CDC-NIH BMBL; ISPE/GAMP); these are standards the products must meet for customers, not certifications Germfree holds. We especially welcome candidates who bring ...

Trace Systems

Quality Manager

Tampa, FL · On-site

Support for internal and external audits - customer audits, corporate audits, ISO audits, etc. * Provides quality-related training to program leadership and key staff responsible for implementing ...

TRACE SYSTEMS

Quality Manager

Tampa, FL · On-site

Support for internal and external audits - customer audits, corporate audits, ISO audits, etc. * Provides quality-related training to program leadership and key staff responsible for implementing ...

Danaher

Senior Quality Engineer

Pensacola, FL · On-site

$83K - $113K/yr

This role ensures compliance with ISO 13485, and ISO 9001 standards, addresses customer complaints, resolves production quality issues, and supports new product introduction projects. Additionally ...

Danaher

Senior Quality Engineer

Pensacola, FL

$83K - $113K/yr

This role ensures compliance with ISO 13485, and ISO 9001 standards, addresses customer complaints, resolves production quality issues, and supports new product introduction projects. Additionally ...

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Showing results 21-40

All JobsIso 11607 JobsIso 11607 Jobs in Florida

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 Florida?

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

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

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

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Iso 11607 jobs near you
Infographic showing various Iso 11607 job openings in Florida as of July 2026, with employment types broken down into 1% As Needed, 16% Full Time, 31% Part Time, 1% Temporary, 33% Contract, and 18% Nights. Highlights an 92% Physical, 5% Hybrid, and 3% Remote job distribution.

Quality Management System (QMS) Specialst-Jacksonville, Florida

Safariland

Baldwin, FL

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted yesterday

New

Safariland rating

6.9

Company rating: 6.9 out of 10

Based on 8 frontline employees who took The Breakroom Quiz

Job description

TOGETHER, WE SAVE LIVES
Quality Management System (QMS) Specialist
Summary
We are seeking a QMS Specialist to administer and continuously support the Quality Management System for ballistic armor manufacturing sites, with responsibility for document control governance, ISO 9001 and BA9000 internal audit coordination, compliance monitoring, and quality system administration.
This salaried exempt role requires independent judgment, discretion, and cross functional coordination to keep QMS documentation accurate, current, audit ready, and aligned with applicable standards, customer requirements, manufacturing practices, and corrective action expectations.
Responsibilities
  • Plan, coordinate, and administer ISO 9001 and BA9000 internal audit activities for ballistic armor manufacturing sites, including audit schedules, scope, evidence requirements, documentation, and follow up priorities
  • Evaluate process and documentation compliance against QMS requirements, manufacturing procedures, inspection records, controlled work instructions, ISO 9001, BA9000, customer, and regulatory expectations
  • Prepare audit summaries, identify and document nonconformances or system gaps, assign and track corrective action ownership, and escalate overdue or high risk items to Quality leadership
  • Own the QMS document control process for supported manufacturing sites, ensuring procedures, forms, work instructions, inspection documents, and quality records are accurate, current, controlled, and accessible
  • Review document change requests for completeness, compliance impact, affected areas, training needs, approval routing, revision history, release control, obsolete document archiving, and record retention requirements
  • Maintain organized electronic and physical quality records, including audit records, training records, inspection related documents, nonconformance records, and corrective action documentation
  • Coordinate QMS training administration by determining affected employee groups, tracking completion, maintaining training records, and helping ensure employees are trained on current procedures before implementation where required
  • Support audit readiness for ballistic armor manufacturing processes, including material traceability, inspection documentation, process controls, and required quality records
  • Monitor document updates, standard changes, audit trends, corrective action status, and site process changes to assess potential impact on ISO, BA9000, customer, regulatory, and internal quality system requirements
  • Partner with Quality, Operations, Engineering, and Production leaders to align controlled documents with actual manufacturing and inspection practices, resolve documentation gaps, and recommend practical QMS improvements
  • Analyze and report QMS activity and risk indicators, including open document changes, audit findings, overdue corrective actions, training status, record completion gaps, and recurring compliance issues
  • Lead standardization of document control, audit preparation, recordkeeping, training documentation, corrective action follow up, and quality system administration practices across ballistic armor manufacturing sites
  • All other duties as assigned

Required Qualifications
  • Associate's or Bachelor's degree in Quality, Engineering, Business, or a related field preferred; equivalent hands on quality, document control, or manufacturing experience will be considered
  • 2-4+ years of experience in manufacturing quality, QMS administration, document control, internal auditing, inspection records, or quality records management
  • Working knowledge of ISO 9001 required; BA9000, ballistic armor, defense manufacturing, or regulated manufacturing experience preferred
  • Experience maintaining controlled documents, quality records, training records, audit files, corrective action logs, and other QMS administrative records
  • Strong attention to detail, organization, follow-through, communication, and ability to support multiple manufacturing sites and priorities
  • Willingness and ability to travel regularly to multiple sites (~20%)

Preferred Qualifications
  • ISO 9001 internal auditor, lead auditor, or similar audit training
  • Experience with ballistic armor, body armor, defense products, composites, textiles, or other regulated manufacturing environments
  • Experience supporting document control, inspection documentation, material traceability, lot records, or manufacturing quality records in a multi-site environment
  • Basic continuous improvement experience, including Lean, Six Sigma, A3, 5S, standard work, or visual management

Why work at Safariland?
At Safariland our colleagues are some of the best and brightest in the industry and we are seeking new team members who exhibit the diverse competencies that will drive The Safariland Group to even greater success while maintaining our culture of being a great place to work. We believe innovation drives winning performance and we constantly challenge ourselves to be the very best in every aspect of our business. We cultivate a work culture driven by our 4 core values; integrity, curiosity, excellence and empowerment and we want associates to be involved in their work and communities so they can achieve their highest level of wellbeing. That is why Safariland offers a comprehensive suite of benefits to promote health and financial security for eligible employees and their families.
Eligible employees are offered:
  • Medical, dental & vision insurance
  • 401(k) with company match
  • Employer paid life insurance and AD&D
  • Employer paid disability
  • Wellness program
  • Adoption assistance
  • Tuition assistance
  • Employee assistance program
  • Work life balance
  • Paid time off (PTO), sick leave and paid holidays throughout the calendar year (consistent with relevant state law and company policies)

The Safariland Group believes in the benefits of a diverse workforce and is committed to equal opportunity and affirmative actions. We pride ourselves on hiring and developing the best people, without regard to age, sex, sexual orientation, gender identity, genetic characteristics, race, color, creed, religion, ethnicity, national origin, alienage, citizenship, disability, marital status, military status, pregnancy, or any other legally recognized protected basis prohibited by applicable law.
For those applicants with disabilities, if you require reasonable accommodation in searching for a job opening or submitting an application, please contact us by calling 888-469-6455.
All employment decisions are solely based on the applicant's qualifications as they relate to the requirements of the position.

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