Source Job

$100,000–$125,000/yr
US Unlimited PTO 12w maternity 12w paternity

  • Lead implementation and improvement of quality management systems, including certifications. - Develop solutions for complex quality challenges and provide training on quality processes. - Conduct audits, manage non-conformance investigations, and drive continuous improvement.

Quality Management Process Improvement Auditing Compliance Data Analysis

10 jobs similar to Sr Quality Systems Specialist

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$134,985–$163,247/yr
US

  • Lead the execution and continuous improvement of quality management systems to ensure compliance with FDA, ICH, GCP, and ISO 9001 standards.
  • Manage electronic Quality Management System (eQMS) including document control, CAPA, risk management, and audit processes.
  • Provide quality oversight for clinical trial activities and software development lifecycle, collaborating with cross-functional teams.

The partner company is a fast-growing healthcare and life sciences organization focused on improving clinical research. It values collaboration, curiosity, and continuous improvement, and supports teams through scalable systems and risk management.

$92,800–$150,000/yr
US

  • Lead quality monitoring initiatives across multi-channel crisis and support services.
  • Develop and implement performance measurement frameworks and operational audits.
  • Drive continuous improvement through data analysis and AI-enabled quality solutions.

The company provides behavioral health and crisis support services at scale through national service networks. It is a mission-driven organization with a collaborative culture focused on professional growth and innovation.

US

  • Provide strategic quality oversight for global clinical operations, including decentralized clinical trials and patient-focused healthcare services.
  • Ensure compliance with global regulations, sponsor expectations, and established quality systems through risk management and continuous improvement.
  • Lead investigations, audits, and CAPA activities to support safe, efficient, and reliable clinical trial delivery.

The partner company is a mission-driven organization focused on improving access to healthcare solutions. They foster a supportive, inclusive, and collaborative work environment with a remote-first culture.

US

  • Lead quality initiatives, audits, and compliance programs to align with client and regulatory standards.
  • Analyze performance data and collaborate with cross-functional teams to implement process improvements.
  • Develop executive reports and tools to drive quality excellence and support operational accuracy.

The partner company operates in the US security and IT sector, focusing on quality and operational excellence. It maintains a dynamic, collaborative culture that values continuous improvement and client satisfaction.

UK 5w PTO

  • Support the development and implementation of quality management systems and continuous improvement initiatives.
  • Track performance metrics, identify process optimization opportunities, and collaborate with cross-functional teams.
  • Participate in root cause analysis, quality inspections, and assist in training staff on quality practices.

Hitachi Energy is a global technology company leading the energy transition with innovative solutions and services. The company fosters a diverse and inclusive workplace with a strong focus on quality and continuous improvement.

US

  • Lead Quality Systems and Regulatory Affairs to ensure compliance with FDA, ISO 13485, and EU MDR.
  • Optimize the electronic Quality Management System (eQMS) and drive sustainable process improvements.
  • Serve as primary quality and regulatory representative during audits, inspections, and regulatory submissions.

CEFALY Technology develops medical devices for migraine relief. It is a growing organization that values quality, compliance, and mentorship.

$77,300–$87,500/yr
US

  • Monitor technical aspects of SGS Natural Resources, Energy, North American Operations in conjunction with Quality Management System and ISO/IEC 17025 requirements.
  • Establish and maintain lean and effective method validation, verification, and consistency to align with technical requirements.
  • Support corrective actions, liaise with site operations and quality managers, and contribute to training technical staff.

SGS is the world's leading testing, inspection and certification company, recognized as the global benchmark for sustainability, quality and integrity. With 99,600 employees operating a network of 2,600 offices and laboratories, they work together to enable a better, safer and more interconnected world.

US

  • Oversee GCP quality systems and provide QA leadership for global clinical operations including decentralized trials.
  • Lead investigations, CAPAs, risk assessments, and audits to ensure regulatory compliance.
  • Review clinical documentation, support vendor qualification, and mentor QA staff.

WEP Clinical partners with biopharmaceutical sponsors to deliver clinical trial services, home health, and market access solutions. With over 15 years of global experience across 150+ countries, the company fosters a collaborative and mission-driven culture.

$180,000–$220,000/yr
US Unlimited PTO

  • Build, maintain, and continuously improve the company's Quality Management System (QMS) and oversee GxP CSV requirements.
  • Own the design and administration of the electronic QMS, including validation, document control, and compliance activities.
  • Lead internal audit and inspection-readiness programs, supporting regulatory inspections and promoting a culture of quality.

Loyal is a clinical-stage veterinary medicine company developing longevity drugs for dogs, targeting the underlying drivers of aging to delay disease and preserve quality of life. As a well-funded startup with teams of scientists, veterinarians, engineers, and creatives, it is pioneering the first FDA-approved lifespan extension medicine.

$160,000–$200,000/yr
US

  • Own Cadence's QMS strategy and regulatory operating model for AI-enabled healthcare software, SaMD, and technology-enabled care workflows.
  • Lead quality system governance across design controls, risk management, CAPA, change control, document control, training, and audit readiness.
  • Partner with Product, Engineering, and Clinical teams to assess regulatory pathway, device classification, and QMS requirements for new software capabilities.

Cadence is a clinical AI company that delivers continuous, proactive care for older adults with chronic conditions. They operate as a full clinical care delivery organization with clinicians working alongside health system partners, helping Medicare save $2M a week.