Minneapolis, MN · On-site
$75K - $97K/yr
This role will partner cross-functionally to ensure compliance with FDA and ISO standards throughout the product lifecycle. Key Responsibilities * Manage CAPAs, nonconformances, root cause ...
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Minneapolis, MN · On-site
$75K - $97K/yr
This role will partner cross-functionally to ensure compliance with FDA and ISO standards throughout the product lifecycle. Key Responsibilities * Manage CAPAs, nonconformances, root cause ...
Support and maintain ISO standards. * Ensure that organizational product quality levels are met utilizing company metrics and visuals to heighten employee awareness downstream. * Interface with all ...
Support and maintain ISO standards. * Ensure that organizational product quality levels are met utilizing company metrics and visuals to heighten employee awareness downstream. * Interface with all ...
ISO 13485 Lead Auditor certification and demonstrates leadership of 3rd party and customer audits. * At least 5 years of Medical Device industry experience under FDA 21 CFR part 820 and ISO 13485 ...
ISO 13485 Lead Auditor certification and demonstrates leadership of 3rd party and customer audits. * At least 5 years of Medical Device industry experience under FDA 21 CFR part 820 and ISO 13485 ...
Eden Prairie, MN · On-site
ISO 13485 Lead Auditor certification and demonstrates leadership of 3rd party and customer audits. * At least 5 years of Medical Device industry experience under FDA 21 CFR part 820 and ISO 13485 ...
Eden Prairie, MN · On-site
ISO 13485 Lead Auditor certification and demonstrates leadership of 3rd party and customer audits. * At least 5 years of Medical Device industry experience under FDA 21 CFR part 820 and ISO 13485 ...
Perform both internal ISO audits and external supplier audits. Participate in the supplier certification process and develop qualification requirements for purchased components and services. * Assure ...
Perform both internal ISO audits and external supplier audits. Participate in the supplier certification process and develop qualification requirements for purchased components and services. * Assure ...
New Brighton, MN · On-site
$64K - $110K/yr
Perform both internal ISO audits and external supplier audits. Participate in the supplier certification process and develop qualification requirements for purchased components and services. * Assure ...
New Brighton, MN · On-site
$64K - $110K/yr
Perform both internal ISO audits and external supplier audits. Participate in the supplier certification process and develop qualification requirements for purchased components and services. * Assure ...
Osseo, MN · On-site
$100K - $115K/yr
Conduct supplier audits (process, system, and product) to ensure compliance with ISO 9001, AS9100, and applicable regulatory standards. * Manage incoming quality issues, root cause analysis, and ...
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Osseo, MN · On-site
$100K - $115K/yr
Conduct supplier audits (process, system, and product) to ensure compliance with ISO 9001, AS9100, and applicable regulatory standards. * Manage incoming quality issues, root cause analysis, and ...
Osseo, MN · On-site
$100K - $115K/yr
Conduct supplier audits (process, system, and product) to ensure compliance with ISO 9001, AS9100, and applicable regulatory standards. * Manage incoming quality issues, root cause analysis, and ...
Osseo, MN · On-site
$100K - $115K/yr
Conduct supplier audits (process, system, and product) to ensure compliance with ISO 9001, AS9100, and applicable regulatory standards. * Manage incoming quality issues, root cause analysis, and ...
$100K - $115K/yr
Conduct supplier audits (process, system, and product) to ensure compliance with ISO 9001, AS9100, and applicable regulatory standards. * Manage incoming quality issues, root cause analysis, and ...
$100K - $115K/yr
Conduct supplier audits (process, system, and product) to ensure compliance with ISO 9001, AS9100, and applicable regulatory standards. * Manage incoming quality issues, root cause analysis, and ...
Vadnais Heights, MN · On-site
$140K/yr
Support and maintain ISO standards. * Ensure that organizational product quality levels are met utilizing company metrics and visuals to heighten employee awareness downstream. * Interface with all ...
Vadnais Heights, MN · On-site
$140K/yr
Support and maintain ISO standards. * Ensure that organizational product quality levels are met utilizing company metrics and visuals to heighten employee awareness downstream. * Interface with all ...
Bloomington, MN · Hybrid
$86K - $111K/yr
Support, maintain, and improve the company's AS9100 and ISO 9001 Quality Management Systems across multiple manufacturing sites. * Lead internal audits, support external audits, and ensure ongoing ...
Bloomington, MN · Hybrid
$86K - $111K/yr
Support, maintain, and improve the company's AS9100 and ISO 9001 Quality Management Systems across multiple manufacturing sites. * Lead internal audits, support external audits, and ensure ongoing ...
Be Seen First
Maple Grove, MN · On-site
$66K - $83K/yr
Conduct 6S audits, internal ISO audits, and process confirmation audits. Monitor the results for conformance, broadly communicate audit results, and drive findings to closure within required ...
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Be Seen First
Maple Grove, MN · On-site
$66K - $83K/yr
Conduct 6S audits, internal ISO audits, and process confirmation audits. Monitor the results for conformance, broadly communicate audit results, and drive findings to closure within required ...
Bloomington, MN · On-site
$86K - $111K/yr
Support, maintain, and improve the company's AS9100 and ISO 9001 Quality Management Systems across multiple manufacturing sites. * Lead internal audits, support external audits, and ensure ongoing ...
Bloomington, MN · On-site
$86K - $111K/yr
Support, maintain, and improve the company's AS9100 and ISO 9001 Quality Management Systems across multiple manufacturing sites. * Lead internal audits, support external audits, and ensure ongoing ...
Minneapolis, MN · On-site
$75K - $97K/yr
Conduct 6S audits, internal ISO audits, and process confirmation audits. Monitor the results for conformance, broadly communicate audit results, and drive findings to closure within required ...
Minneapolis, MN · On-site
$75K - $97K/yr
Conduct 6S audits, internal ISO audits, and process confirmation audits. Monitor the results for conformance, broadly communicate audit results, and drive findings to closure within required ...
Maple Grove, MN · On-site
$75K - $97K/yr
Conduct 6S audits, internal ISO audits, and process confirmation audits. Monitor the results for conformance, broadly communicate audit results, and drive findings to closure within required ...
Maple Grove, MN · On-site
$75K - $97K/yr
Conduct 6S audits, internal ISO audits, and process confirmation audits. Monitor the results for conformance, broadly communicate audit results, and drive findings to closure within required ...
Must be able to demonstrate understanding of medical device regulations (ISO 13485, 21 CFR 820, etc.). Accountabilities & Responsibilities Develop and maintain quality systems, processes, and ...
Must be able to demonstrate understanding of medical device regulations (ISO 13485, 21 CFR 820, etc.). Accountabilities & Responsibilities Develop and maintain quality systems, processes, and ...
Big Lake, MN · On-site
$64K - $110K/yr
Experience working in an ISO environment, preferably AS9100, and conducting internal and supplier audits. * LEAN / Six Sigma training and demonstrated application. * Proficient PC skills in a Windows ...
Big Lake, MN · On-site
$64K - $110K/yr
Experience working in an ISO environment, preferably AS9100, and conducting internal and supplier audits. * LEAN / Six Sigma training and demonstrated application. * Proficient PC skills in a Windows ...
Experience working in an ISO environment, preferably AS9100, and conducting internal and supplier audits. * LEAN / Six Sigma training and demonstrated application. * Proficient PC skills in a Windows ...
Experience working in an ISO environment, preferably AS9100, and conducting internal and supplier audits. * LEAN / Six Sigma training and demonstrated application. * Proficient PC skills in a Windows ...
$88K - $108K/yr
Ensure compliance with applicable regulatory standards (e.g., FDA CFR 820, ISO 13485, ISO 14971) and support audit readiness and execution * Maintain and assess effectiveness of CAPAs and quality ...
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$88K - $108K/yr
Ensure compliance with applicable regulatory standards (e.g., FDA CFR 820, ISO 13485, ISO 14971) and support audit readiness and execution * Maintain and assess effectiveness of CAPAs and quality ...
Plymouth, MN · On-site
$77K - $99K/yr
Understanding of FDA regulations and ISO 13485 standards * Strong problem-solving and analytical skills
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Plymouth, MN · On-site
$77K - $99K/yr
Understanding of FDA regulations and ISO 13485 standards * Strong problem-solving and analytical skills
| Aspect | Iso 11607 | Packaging Technician |
|---|---|---|
| Certifications | Standards for sterile packaging | Often certified in packaging processes |
| Work Environment | Manufacturing and sterile packaging facilities | Packaging lines, production areas |
| Industry Usage | Medical device and pharmaceutical packaging | Medical device, pharmaceutical, and consumer goods |
| Primary Focus | Ensuring packaging meets sterilization and safety standards | Assembling, 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.
$75K - $97K/yr
Contractor
Re-posted 21 days ago
Job Title: Quality Assurance Engineer – Medical Devices
Location: Northwest Minneapolis Metro Area
Type: 6-Month Contract-to-Hire
Job Summary
Seeking a Quality Assurance Engineer to support quality systems, manufacturing operations, CAPA, validation, audits, and DHF activities within a medical device environment. This role will partner cross-functionally to ensure compliance with FDA and ISO standards throughout the product lifecycle.
Key Responsibilities
Required Qualifications
