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Senior Quality Specialist

QA EngineerQA EngineerFull TimeRemoteTeam 501-1,000H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

14 days ago

Salary

Not specified

No structured requirement data.

Job Description

Quality Specialists plays a critical role in ensuring that products, services, and processes meet internal and external standards and requirements. The Senior Quality Specialist supports quality initiatives by managing audits and suppliers, analyzing quality data, managing client complaints, internal deviations, and CAPAs, overseeing the document and change management processes, participating in root cause analysis, and collaborating cross-functionally to drive continuous improvement across the organization. Maintain and enforce company quality systems in accordance with applicable standards (e.g., ISO 9001, GxP) Ensure compliance with internal procedures, customer requirements, and regulatory guidelines. Compile quality system data for presentation in Management Review Participate in internal and external audits and support audit readiness efforts. Coordinate and provide oversight to the supplier management process. Promote a culture of continuous improvement, accountability, and operational excellence. Own the document control process and assist in the creation, review, revision, and approval of standard operating procedures. Support change management processes, ensuring proper documentation and validation activities. Manage the end-to-end process for addressing complaints, deviations, and CAPAs. Lead or support the investigation and documentation of complaints and deviations including root cause analysis and identification of CAPA. Ensure all complaint and deviation records are accurate, complete, and compliant with applicable regulatory and quality standards. Monitor complaint and deviation trends and provide regular reports to management with recommendations for improvement. Track and verify the effectiveness of implemented CAPAs. Develop and/or deliver training materials on quality-related policies, procedures, and processes. Serve as a resource for teams on quality standards and best practices. Coordinate with the Learning and Development team to ensure development and assignment of quality-related training. Analyze quality metrics, prepare trend reports, and suggest opportunities to optimize processes and reduce quality risks. Collaborate with cross-functional teams to implement process improvements and quality initiatives.

Job Requirements

  • Bachelor’s degree in Life Sciences, Engineering, Quality, or a related field.
  • 2-5 years of experience in Quality Assurance, Quality Control, or Quality Systems (regulated industry or professional services preferred).
  • Demonstrated experience in at least two of the following areas:
  • Complaint and/or Deviation
  • CAPA
  • Document control
  • Audits
  • Change Management
  • Supplier Management
  • $80,000 - $95,000 a year (Average base salary range - not including benefits).

Benefits

  • Comprehensive Health Insurance coverage
  • 24 days of Paid Time Off
  • ESOP/401K - 15% Company Contribution (US Only)
  • Company paid Life Insurance
  • Company paid Long Term Disability

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