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Iso 11607 Jobs in Colorado (NOW HIRING)

Technical Quality Manager

Denver, CO · On-site

$77K - $87K/yr

Previous experience with ISO/IEC 17025 requirements is preferred. * Preferred Previous experience in a Quality Control related role is preferred. * Must have proven technical experience and knowledge ...

Technical Quality Manager

Denver, CO · On-site

$77K - $87K/yr

Previous experience with ISO/IEC 17025 requirements is preferred. * Preferred Previous experience in a Quality Control related role is preferred. * Must have proven technical experience and knowledge ...

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CNC Quality Inspector

Louviers, CO · On-site

$26 - $35/hr

We are AS9100 and ISO 9001 certified, and completing CMMC Level 2 certification. Shift: Day shift Role Summary We're looking for an experienced Quality Inspector to support first article, in-process ...

Quality Assurance Specialist

Monument, CO · On-site

$65K - $70K/yr

Maintain and support the company's quality management system (QMS) in accordance with ISO 13485, FDA QSR (21 CFR Part 820), and other applicable regulatory requirements. * Create, revise, and ...

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Quality Assurance Specialist

Monument, CO · On-site

$65K - $70K/yr

Maintain and support the company's quality management system (QMS) in accordance with ISO 13485, FDA QSR (21 CFR Part 820), and other applicable regulatory requirements. * Create, revise, and ...

Quality Assurance Specialist

Monument, CO · On-site

$65K - $70K/yr

Maintain and support the company's quality management system (QMS) in accordance with ISO 13485, FDA QSR (21 CFR Part 820), and other applicable regulatory requirements. * Create, revise, and ...

Quality Engineer II

Denver, CO · On-site

$74K - $95K/yr

Support and improve ISO-aligned QMS compliance , including participation in internal, customer, and registrar audits. * Drive progress toward strategic business and quality KPIs (e.g., FQR reduction ...

Desgin Quality Engineer

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 ...

Maintain the local Quality Management System (QMS) and ensure ongoing ISO 9001 certification readiness * Lead internal quality audits and support external audits, including certification, customer ...

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Quality Engineer

Englewood, CO · On-site

$28 - $41/hr

Help maintain and apply our AS9100 / ISO 9001-aligned quality processes * Work closely with engineers to compose quality-at-the-source principles * Support customer audits and source inspections ...

Help maintain and apply our AS9100 / ISO 9001-aligned quality processes * Work closely with engineers to compose quality-at-the-source principles * Support customer audits and source inspections ...

QMS Ownership (IATF 16949 & ISO 9001): Establish, maintain, and improve the site Quality Management System. Act as the lead auditor for internal audits and the primary contact for registrar and ...

Showing results 21-40

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 Colorado? For Iso 11607 jobs in Colorado, the most frequently searched job titles are:
What job categories do people searching Iso 11607 jobs in Colorado look for? The top searched job categories for Iso 11607 jobs in Colorado are:
What cities in Colorado are hiring for Iso 11607 jobs? Cities in Colorado with the most Iso 11607 job openings:
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.

Technical Quality Manager

SGS U.S. Holding Inc.

Denver, CO • On-site

$77K - $87K/yr

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 21 days ago


Job description

Company Description

We are SGS - the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.

Job Description

This position is responsible for monitoring the technical aspects of the SGS Natural Resources, Energy, North American Operations in conjunction with requirements of the Quality Management System and ISO/IEC17025. This includes method validation, verification, method transfer, assessment of client data, technical internal audits and proficiency testing/round robin (PT/RR) performance. This position involves travel and flexibility to meet both the needs of the laboratory as well as the clientele.

  • Establish, improve and maintain lean and effective method validation, verification and method consistency to align with the current technical requirements and with the international standard ISO/IEC 17025 for testing laboratories
  • Prepare technical templates for protocols and procedures as applicable.
  • Reviews and approves method validation / verification / transfer / development
  • Support effective corrective action to on time closure with other responsible personnel; follow up on effectiveness of corrective action
  • Liaise with site Operations Managers, Quality Systems Manager, Chief Chemists and Client Services personnel in response to complaints involving data non-conformances
  • Work with Chief Chemists and department Supervisors to continuously improve lab technical capabilities and services.
  • Contribute to the training and development of all technical staff in standardised, technical quality policies and procedures.
  • Remote interrogation of NAM SLIM databases to monitor Quality Control conformance as well as organize and schedule site audits, if necessary, for same.
  • Review and evaluate QC deviations for impact assessment.
  • Monitor internal QC and PT/RR performance for biases and trends across the regional business operations and recommend actions as required.
  • Prepare statistical data evaluation for client complaints, audit findings, PT/RR performance and/or quality control failures as assigned
  • Advises and reviews LIMS performance module set ups to ensure appropriate tolerances, limits and verification criteria are in place when methods are developed/modified and/or equipment is introduced.
  • Prevent release of any report, Certificate of Analysis, or information to the customer when a deficiency is identified during a technical audit.
  • Approve method development forms provided by the client or SGS for method transfer studies (changes, validation, verification etc.)
  • Ensure major technical non-conformances are brought to the attention of the Quality Systems Manager and Regional Business Manager.
  • May work as a backup in designated areas in the absence of Quality Systems Manager
Qualifications
  • A minimum of a BSc degree (or equivalent) is required.
  • Previous experience in validation and verification of methods is required.
  • Previous experience in statistical evaluation is required.
  • Previous experience with ISO/IEC 17025 requirements is preferred.
  •  Preferred Previous experience in a Quality Control related role is preferred.
  • Must have proven technical experience and knowledge in analytical laboratory operations
  • Must have experience and expertise in data analysis and statistical evaluation
  • Relevant technical knowledge in ISO/IEC 17025 Candidates must be proficient in using various type of computer software (Word, Excel, Outlook etc.).
  • Must be able to multitask and schedule on time delivery: Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment.
  • Demonstrates excellent verbal and written communication skills including grammar and composition.
  • Ability to work well with others & independently.
  • Works well under pressure.
  • Ensures full compliance with the company's Health & Safety, Code of Integrity, and Professional Conduct policies.
  • Appropriate attitude, constant vigilance, attention to detail and following SGS policies and procedures applicable to the business
Additional Information

Compensation

The expected salary range for this position is $77,300 to $87,500 annually. This range represents the minimum and maximum base salary we reasonably expect to pay for this role. Actual compensation within the range will depend on skills, experience, and qualifications.

Our Benefits

We care about your total well-being and will support you with the following, subject to your location and role.

  • Health: Medical, dental and vision insurance, life insurance, employee assistance programs.
  • Wealth: In addition to base pay, we offer 401(k) with company match (immediate vesting upon enrollment).
  • Happiness:
    • Professional Growth: Online training courses, virtual and classroom development experiences, tuition reimbursement program
    • Work-Life Balance: Paid-time off and family leave

In compliance with applicable state and local pay transparency laws, we provide clear and equitable compensation information for all applicants.

Position anticipated to close August 3rd, 2026. 

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.

This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time.

If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a call back.  Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.