San Diego, CA · On-site
Maintain compliance with ISO 13485, AS9100, ISO 9001, ITAR, and customer-specific requirements. * Develop, revise, review, and control quality system procedures, policies, forms, and records.
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San Diego, CA · On-site
Maintain compliance with ISO 13485, AS9100, ISO 9001, ITAR, and customer-specific requirements. * Develop, revise, review, and control quality system procedures, policies, forms, and records.
Durham, NC · On-site
With integration of ISO 9001 (globally) recognized standard for Quality Management Systems and ISO 13485 (internationally recognized standard for Quality Management Systems designed for the medical ...
Durham, NC · On-site
With integration of ISO 9001 (globally) recognized standard for Quality Management Systems and ISO 13485 (internationally recognized standard for Quality Management Systems designed for the medical ...
Madison, WI · On-site
$30/hr
Follow all established procedures in compliance with FDA and ISO 13485:2008 standards. * Maintain documentation in accordance with GMP and company policies. * Adapt to various inspection assignments ...
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Madison, WI · On-site
$30/hr
Follow all established procedures in compliance with FDA and ISO 13485:2008 standards. * Maintain documentation in accordance with GMP and company policies. * Adapt to various inspection assignments ...
$90K - $105K/yr
Own ISO 13485 and ISO 22442 compliance end-to-end, with real authority over final release decisions * Sit at the center of a quality culture-building effort at a site the company is actively ...
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$90K - $105K/yr
Own ISO 13485 and ISO 22442 compliance end-to-end, with real authority over final release decisions * Sit at the center of a quality culture-building effort at a site the company is actively ...
$90K - $105K/yr
Own ISO 13485 and ISO 22442 compliance end-to-end, with real authority over final release decisions * Sit at the center of a quality culture-building effort at a site the company is actively ...
$90K - $105K/yr
Own ISO 13485 and ISO 22442 compliance end-to-end, with real authority over final release decisions * Sit at the center of a quality culture-building effort at a site the company is actively ...
Santa Clara, CA · On-site
$84K - $109K/yr
Lead design transfer and production support activities, ensuring compliance with FDA/ISO 13485 and alignment with manufacturing readiness. * Own multiple subassemblies for a surgical robotics ...
Santa Clara, CA · On-site
$84K - $109K/yr
Lead design transfer and production support activities, ensuring compliance with FDA/ISO 13485 and alignment with manufacturing readiness. * Own multiple subassemblies for a surgical robotics ...
Indianapolis, IN · On-site +1
This position requires a strong understanding of Design Control requirements and regulatory standards such as FDA 21 CFR Part 820, ISO 13485, and ISO 14971, ensuring compliance and maintaining Design ...
Indianapolis, IN · On-site +1
This position requires a strong understanding of Design Control requirements and regulatory standards such as FDA 21 CFR Part 820, ISO 13485, and ISO 14971, ensuring compliance and maintaining Design ...
Camarillo, CA · On-site
$95K - $105K/yr
Ensure suppliers meet ISO 13485 and FDA QSR/QMSR expectations. Supplier Auditing and Oversight * Plan and execute supplier audits in accordance with risk-based audit schedules. * Evaluate compliance ...
Camarillo, CA · On-site
$95K - $105K/yr
Ensure suppliers meet ISO 13485 and FDA QSR/QMSR expectations. Supplier Auditing and Oversight * Plan and execute supplier audits in accordance with risk-based audit schedules. * Evaluate compliance ...
$60K/yr
Working knowledge of ISO 13485 or other regulated quality systems.
$60K/yr
Working knowledge of ISO 13485 or other regulated quality systems.
ISO 13485 Compliance: Ensure manufacturing processes comply with ISO 13485 and regulatory requirements for medical device production. Quality & Process Improvement: Work closely with Quality ...
ISO 13485 Compliance: Ensure manufacturing processes comply with ISO 13485 and regulatory requirements for medical device production. Quality & Process Improvement: Work closely with Quality ...
Cincinnati, OH · On-site
$69K - $89K/yr
This role partners cross-functionally to ensure compliance with ISO 9001, ISO 13485, FDA Quality System Regulation (21 CFR Part 820), and applicable customer and regulatory requirements. The Quality ...
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Cincinnati, OH · On-site
$69K - $89K/yr
This role partners cross-functionally to ensure compliance with ISO 9001, ISO 13485, FDA Quality System Regulation (21 CFR Part 820), and applicable customer and regulatory requirements. The Quality ...
Drive and manage ISO 13485 certification, surveillance audits, and recertification cycles. * Oversee and execute FDA Site Registration, and ongoing regulatory maintenance for the manufacturing site.
Drive and manage ISO 13485 certification, surveillance audits, and recertification cycles. * Oversee and execute FDA Site Registration, and ongoing regulatory maintenance for the manufacturing site.
Atlanta, GA · On-site
Ensure manufacturing processes comply with ISO 13485 and regulatory requirements for medical device production. • Quality & Process Improvement: Work closely with Quality Assurance teams to ...
Atlanta, GA · On-site
Ensure manufacturing processes comply with ISO 13485 and regulatory requirements for medical device production. • Quality & Process Improvement: Work closely with Quality Assurance teams to ...
This role requires expertise in ISO 9001, ISO 13485, and IATF 16949 certifications, as well as lean daily management, Six Sigma, and strategic deployment tools like the Hoshin Matrix and Goal ...
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This role requires expertise in ISO 9001, ISO 13485, and IATF 16949 certifications, as well as lean daily management, Six Sigma, and strategic deployment tools like the Hoshin Matrix and Goal ...
Alpharetta, GA · On-site
ISO 13485 Compliance: Ensure manufacturing processes comply with ISO 13485 and regulatory requirements for medical device production. * Quality & Process Improvement: Work closely with Quality ...
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Alpharetta, GA · On-site
ISO 13485 Compliance: Ensure manufacturing processes comply with ISO 13485 and regulatory requirements for medical device production. * Quality & Process Improvement: Work closely with Quality ...
Atlanta, GA · On-site
ISO 13485 Compliance: Ensure manufacturing processes comply with ISO 13485 and regulatory requirements for medical device production. * Quality & Process Improvement: Work closely with Quality ...
Quick apply
Atlanta, GA · On-site
ISO 13485 Compliance: Ensure manufacturing processes comply with ISO 13485 and regulatory requirements for medical device production. * Quality & Process Improvement: Work closely with Quality ...
ISO 13485 Compliance: Ensure manufacturing processes comply with ISO 13485 and regulatory requirements for medical device production. Quality & Process Improvement: Work closely with Quality ...
ISO 13485 Compliance: Ensure manufacturing processes comply with ISO 13485 and regulatory requirements for medical device production. Quality & Process Improvement: Work closely with Quality ...
Drive and manage ISO 13485 certification, surveillance audits, and recertification cycles. * Oversee and execute FDA Site Registration, and ongoing regulatory maintenance for the manufacturing site.
Drive and manage ISO 13485 certification, surveillance audits, and recertification cycles. * Oversee and execute FDA Site Registration, and ongoing regulatory maintenance for the manufacturing site.
Drive and manage ISO 13485 certification, surveillance audits, and recertification cycles. * Oversee and execute FDA Site Registration, and ongoing regulatory maintenance for the manufacturing site.
Drive and manage ISO 13485 certification, surveillance audits, and recertification cycles. * Oversee and execute FDA Site Registration, and ongoing regulatory maintenance for the manufacturing site.
Indianapolis, IN · On-site
... 820, ISO 13485, ISO 14971, and applicable regulatory standards. • Strong knowledge of Design Controls and medical device product development. • Experience with Design History File (DHF ...
Indianapolis, IN · On-site
... 820, ISO 13485, ISO 14971, and applicable regulatory standards. • Strong knowledge of Design Controls and medical device product development. • Experience with Design History File (DHF ...
$14.90 - $17.26
20% of jobs
$17.55 is the 25th percentile. Wages below this are outliers.
$17.26 - $19.62
43% of jobs
$21.29 is the 75th percentile. Wages above this are outliers.
$19.62 - $21.98
18% of jobs
$21.98 - $24.34
5% of jobs
$24.34 - $26.70
13% of jobs
$26.70 - $29.06
2% of jobs
$29.06 - $31.42
0% of jobs
$31.42 - $33.78
0% of jobs
$33.78 - $36.15
0% of jobs
$36.15 - $38.51
0% of jobs
$38.51 - $40.87
0% of jobs
$14
$21
$40
Professionals in an ISO 13485 quality assurance role are typically responsible for developing, implementing, and maintaining quality management systems specific to medical devices. Their daily tasks include preparing documentation, conducting internal audits, ensuring compliance with regulatory standards, managing nonconformances, and coordinating corrective actions. They often collaborate closely with engineering, manufacturing, and regulatory affairs teams to address quality issues and facilitate continuous improvement. This position involves significant attention to detail and communication to uphold the organization’s quality objectives and regulatory commitments.
An ISO 13485 job typically involves roles in quality management, regulatory compliance, and manufacturing within the medical device industry. Professionals in these roles ensure that companies adhere to ISO 13485, the international standard for quality management systems in medical devices. Responsibilities may include managing audits, maintaining documentation, overseeing regulatory compliance, and improving quality processes. These jobs are crucial for ensuring product safety, consistency, and compliance with regulatory requirements.
To thrive in an ISO 13485 role, you need a strong understanding of quality management systems for medical devices, regulatory requirements, and risk management principles, often supported by a background in engineering, life sciences, or quality assurance. Familiarity with audit processes, CAPA (Corrective and Preventive Action) systems, and certifications like Certified Quality Auditor (CQA) or ISO 13485 Lead Auditor are highly valued. Attention to detail, problem-solving abilities, and effective communication set outstanding candidates apart. These skills ensure compliance with stringent regulations and help maintain product quality and patient safety in the medical device industry.
Full-time
Medical, Dental, Vision, Retirement, PTO
Posted 23 days ago
Position Summary
The Quality Systems Engineer is the primary owner and administrator of the XLR8 EMS Quality Management System (QMS). This role is responsible for maintaining, monitoring, and continuously improving the company's quality system to ensure compliance with ISO 13485, AS9100, ISO 9001, ITAR, customer requirements, and applicable regulatory standards. The position is focused exclusively on quality system management, compliance, audits, document control, CAPA administration, training compliance, and certification maintenance, and does not have responsibility for manufacturing process quality, supplier quality, inspection activities, or product quality engineering.
Key Responsibilities
Required Qualifications
Preferred Qualifications
Benefits
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Electrical equipment, appliance, and component manufacturing
51 - 200 Employees
San Clemente, CA, US
2013
