Quality Assurance Specialist
About The Position
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. Role Overview The Quality Assurance Specialist owns one or more defined quality system processes or workstreams (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.
Requirements
- Typically, 2–4 years of experience in quality systems, compliance, audits, or regulated environments
- Working knowledge of Quality Management Systems and compliance requirements
- Ability to independently execute quality processes within defined scope
- Strong attention to detail and documentation discipline
- Ability to interpret and apply procedures, standards, and regulations
- Proficiency with document control systems and quality tracking tools
- Clear written and verbal communication skills
- Professional judgment, accountability, and strong follow‑through
Nice To Haves
- Bachelor’s degree in Quality, Life Sciences, Engineering, Manufacturing, Business, or related field Preferred.
- IPC -610 A Industry Printed Cricut board strongly recommended
Responsibilities
- 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 workstreams
- 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
- 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
- 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
- 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
- Maintain training and qualification records for personnel
- Coordinate required training and monitor completion status
- Escalate training gaps or compliance risks as needed
- Partner with Manufacturing, Operations, Engineering, Supply Chain, and Regulatory teams
- Communicate quality requirements, findings, and expectations clearly
- Support implementation of corrective actions across functions
- 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
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
