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Iso 11607 Jobs in Colorado (NOW HIRING)

Lancesoft

Sr Packaging Engineer - Exempt

Lafayette, CO · On-site

$60 - $70/hr

Validation of processes for packaging medical devices as per ISO 11607-2 * Strong working knowledge of FDA Medical Devices Part 820 Quality System (QS) Regulation & Medical Device Good Manufacturing ...

Excelitas Technologies

QMS Manager

Boulder, CO · On-site

$115K - $135K/yr

Ensure adherence to ISO standards such as ISO 9001, ISO 13485, ISO 14971, and FDA 21 CFR 820 according to site accreditation requirements * Address and resolve customer complaints through effective ...

Mill Rock Packaging

Quality Manager (56224)

Aurora, CO · On-site

$80K - $100K/yr

Lead the internal audit program for ISO 9001, ISO 14001, FSSC 22000, FSC, and SFI, and help ensure findings turn into meaningful improvements. * Champion process improvement initiatives that raise ...

MILL ROCK PACKAGING

Quality Manager (56224)

Aurora, CO · On-site

Lead the internal audit program for ISO 9001, ISO 14001, FSSC 22000, FSC, and SFI, and help ensure findings turn into meaningful improvements. * Champion process improvement initiatives that raise ...

Injectech LLC

Quality Engineer

Fort Collins, CO · On-site

$71K - $91K/yr

Ensure compliance with ISO 13485 standards, company Quality Management System (QMS) requirements, and applicable regulatory expectations. * Support the onboarding, training, and development of ...

Injectech

Quality Engineer

Fort Collins, CO · On-site

$71K - $91K/yr

Ensure compliance with ISO 13485 standards, company Quality Management System (QMS) requirements, and applicable regulatory expectations. * Support the onboarding, training, and development of ...

Injectech

Quality Engineer

Fort Collins, CO · On-site

Ensure compliance with ISO 13485 standards, company Quality Management System (QMS) requirements, and applicable regulatory expectations. * Support the onboarding, training, and development of ...

Injectech LLC

Quality Engineer

Fort Collins, CO · On-site

$75K - $110K/yr

Ensure compliance with ISO 13485 standards, company Quality Management System (QMS) requirements, and applicable regulatory expectations. * Support the onboarding, training, and development of ...

Highridge Medical

Sr Quality Design Engineer

Westminster, CO · On-site

$89K - $121K/yr

Lead risk management activities in accordance with ISO 14971. Collaborate effectively/ productively with all departments by developing a team atmosphere. This is not an exhaustive list of duties or ...

Humetis Group

Quality Supervisor

Colorado Springs, CO · On-site

This is a high-impact role responsible for ensuring ongoing compliance with ISO 9001 , UL certifications , and customer-specific quality requirements. If you're a hands-on quality leader with a ...

Collabera

Design Quality Engineer III

Boulder, CO

$74K - $96K/yr

ISO, IEEE, CMMI), and FDA Quality System Regulations and their impact on internal procedures, software quality, safety and efficacy of products Experience in risk evaluation techniques, such as ...

Highridge Medical

Sr Quality Design Engineer

Westminster, CO · On-site

$89K - $121K/yr

Working understanding of ISO 13485 and ISO 14971 Experience with the MDSAP program and working knowledge of FDA and EU medical device regulations, design assurance, risk analysis techniques, and ...

CYNET SYSTEMS

Manufacturing Engineer I

Henderson, CO · On-site

$25 - $30/hr

Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.

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All JobsIso 11607 JobsIso 11607 Jobs in Colorado

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.
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Iso 11607 jobs near you
Infographic showing various Iso 11607 job openings in Colorado as of August 2026, with employment types broken down into 90% Full Time, 2% Part Time, 6% Contract, and 2% Nights. Highlights an 92% Physical, 2% Hybrid, and 6% Remote job distribution.

Sr Packaging Engineer - Exempt

Lancesoft

Lafayette, CO • On-site

$60 - $70/hr

Temporary

Re-posted 3 days ago

Job description


We are seeking a dedicated and experienced professional to join our team in Lafayette, CO. This role offers the opportunity to work in a dynamic environment, supporting the CST business unit with a focus on Enabling Technologies products. The position is full-time through November 2026, transitioning to part-time through April 2027, with the potential for a return to full-time based on project needs.
Must Have:
  • Change control of Medical Devices
  • Equipment Commissioning / Qualification
  • Process Validation
  • Computer System Validation (CSV)
  • Manufacturing, Packaging and Laboratory Equipment
  • Technical experience (Troubleshooting) or any similar experience or background
  • Quality / Process Control / Assurance of Medical Devices
  • Design and development of a packaging system for terminally sterilized medical devices as per ISO 11607-1 and corresponding ASTM and ISTA standards
  • Validation of processes for packaging medical devices as per ISO 11607-2
  • Strong working knowledge of FDA Medical Devices Part 820 Quality System (QS) Regulation & Medical Device Good Manufacturing Practices
  • Experience in equipment IQ
  • Process Validation Lifecycle (from process characterization, OQ to PQ)
  • 5 years experience with a BS in Packaging or related engineering field or 3 years with MS
  • Sterile Barrier Testing
Nice to Have:
  • 3D Modeling
  • Applied Minitab analysis
  • Cost savings analysis
Responsibilities:
  • Lead and support packaging-related work tied to manufacturing transfer, process validation, and design verification in a regulated medical device environment.
  • Collaborate with R&D, manufacturing, quality, and supply chain teams.
  • Develop and execute packaging test protocols and reports.
  • Support validation and verification documentation.
  • Evaluate packaging changes and associated technical rationale.
  • Ensure compliance with FDA and EU MDR expectations.
  • Design, develop, and test a wide variety of containers for product protection, display, and handling.
  • Determine packaging specifications considering product nature, cost limitations, legal requirements, and protection needs.
  • Design package exteriors considering product identification, sales appeal, aesthetic quality, and production techniques.
Technical Skills Required:
  • Packaging engineering experience in regulated medical device or other regulated industries
  • Manufacturing transfer, process validation, and design verification experience
  • Working knowledge of FDA and EU MDR requirements, including technical documentation and justification support
Education Required:
  • Bachelor's degree in Packaging Engineering, Mechanical Engineering, Biomedical Engineering, or related technical field.
Years'Experience Required:
  • Typically 5 to 8 years of relevant packaging engineering experience, with a strong preference for experience in regulated medical device environments.
Work Schedule:
  • Full-time support at 40 hours per week through November 2026, then part-time (20 hours per week) through April 2027.
  • Onsite 4 days per week, with one day remote allowed.
Interview Timeline:
  • As soon as possible, ideally within 1 to 2 weeks of candidate submission.

Meet Your Recruiter
Manikandan H
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About LanceSoft

Sourced by ZipRecruiter

Established in 2000, LanceSoft is a Certified MBE and Woman-Owned organization. Lancesoft Inc. is one of the highest rated companies in the industry. We have been recognized as one of the Largest Staffing firms and ranked in the top 50 fastest Growing Healthcare Staffing firms in 2022. Lancesoft offers short- and long-term contracts, permanent placements, and travel opportunities to credentialed and experienced professionals throughout the United States. We pride ourselves on having industry leading benefits. We understand the importance of partnering with an expert who values your needs, which is why we're 100% committed to finding you an assignment that best matches your career and lifestyle goals. Our team of experienced career specialists takes the time to understand your needs and match you with the right job Lancesoft has been chosen by Staffing Industry Analysts as one of the Best Staffing Firms to Work for.LanceSoft specializes in providing Registered Nurses, Nurse Practitioners, LPNs/LVNs, Social Workers, Medical Assistants, and Certified Nursing Assistants to work in Acute Care Centers, Skilled Nursing Facilities, Long-Term Care centers, Rehab Facilities, Behavioral Health Centers, Drug & Alcohol Facilities, Home Health & Community Health, Urgent Care Clinics, and many other provider-based facilities.

Industry

Recruiting and staffing services

Company size

1,001 - 5,000 Employees

Headquarters location

Herndon, VA, US

Year founded

2000

Social media

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