Quality Assurance Specialist
Listed on 2026-09-20
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Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, Regulatory Compliance Specialist, Quality Control - QC Analysts/Managers
Job Summary
We begin with dreams. Dreams drive our motivation. Dreams are our future. The world’s dreams, people’s dreams, our dreams. Our passion creates ideas that make dreams come alive. Technology and products that were only dreams become reality. All for dreams. Dreams challenge and the Nidec-Group will continue to meet the challenge. For the world’s and people’s tomorrows; the world’s first, the world’s best technologies and products;
we will continue our part in creating a better society. The Quality Assurance Specialist is an intermediate professional role responsible for independently executing and maintaining key Quality Management System (QMS) processes to ensure ongoing compliance with internal standards, customer requirements, and applicable regulations. This role applies strong procedural discipline, technical compliance knowledge, and professional judgment to support audit readiness, issue resolution, and continuous improvement.
The Quality Assurance Specialist owns one or more defined quality system processes or work streams (e.g., document control, CAPA coordination, audit support, training compliance). The role moves beyond entry‑level execution into independent ownership, interpretation of requirements, and influence on compliance outcomes. This position typically reports to a Senior Quality Specialist, Quality Systems Manager, Quality Manager, or Compliance Leader.
Key Responsibilities- Independent Quality System Execution
Independently execute assigned Quality Management System (QMS) processes
Ensure quality activities are completed accurately, on time, and in compliance with procedures
Serve as the point of accountability for defined quality system work streams - Documentation Control & Records Management
Manage the lifecycle of quality documents and records (creation, revision, approval, archiving)
Ensure documentation complies with internal policies and regulatory requirements
Conduct periodic reviews to maintain document accuracy and relevance - Nonconformance & CAPA Coordination
Independently document, track, and coordinate nonconformances and deviations
Support root‑cause analysis activities and CAPA development
Track corrective and preventive actions to completion and perform effectiveness checks - Audit Support & Compliance Execution
Support internal, customer, and third‑party audits with minimal supervision
Prepare audit evidence, participate in audits, and coordinate responses
Track audit actions and ensure timely and effective closure - Quality Data, Metrics & Reporting
Collect, verify, and maintain quality metrics and KPIs
Ensure data accuracy and integrity across quality systems
Support trend analysis and identification of recurring compliance issues - Training & Qualification Management
Maintain training and qualification records for personnel
Coordinate required training and monitor completion status
Escalate training gaps or compliance risks as needed - Cross‑Functional Collaboration
Partner with Manufacturing, Operations, Engineering, Supply Chain, and Regulatory teams
Communicate quality requirements, findings, and expectations clearly
Support implementation of corrective actions across functions - Process Improvement & Standardization
Identify opportunities to improve quality system efficiency or clarity
Support updates to quality procedures, templates, and workflows
Apply lessons learned to strengthen compliance and execution discipline - Knowledge Sharing & Informal Mentorship
Provide informal guidance to Quality Assurance Specialist I roles
Share best practices related to documentation, audits, and CAPA execution
Support onboarding of new quality specialists as needed
- Education & Experience
Bachelor’s degree in Quality, Life Sciences, Engineering, Manufacturing,…
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