Quality Specialist, NA
About The Position
The Quality Specialist provides administrative, technical, and operational support for organizational Quality System activities. The role helps maintain quality records, support investigations, manage documentation, coordinate quality activities, and ensure compliance with company procedures. Working under general supervision, the specialist develops knowledge of quality systems, regulatory requirements, supplier quality processes, and risk-based decision-making. This developmental position is designed to prepare individuals for progression into Quality Specialist roles.
Requirements
- 1–3 years of experience in Quality, Manufacturing, Regulatory, Operations, Supply Chain, or a related field.
- Strong organizational and time-management skills.
- Attention to detail and accuracy.
- Effective verbal and written communication skills.
- Proficiency with Microsoft Office applications.
- Ability to manage multiple priorities and meet deadlines.
- Ability to work collaboratively across functions.
Nice To Haves
- Experience in a regulated environment is preferred but not required.
- An associate's or bachelor's degree in Science, Engineering, Quality, Business, or a related field is preferred; an equivalent combination of education and relevant experience may be considered.
Responsibilities
- Support day-to-day quality activities in accordance with company procedures.
- Maintain quality records and databases so documentation is complete, accurate, and audit-ready.
- Assist with document control, including routing, tracking, filing, and archiving quality documents.
- Support training record management and quality system compliance activities.
- Prepare, organize, and manage quality documentation.
- Assist with creating and revising procedures, forms, work instructions, and specifications.
- Maintain records in accordance with retention and compliance requirements.
- Support data entry and maintenance within quality management systems.
- Assist with investigations, deviations, nonconformances, and CAPA activities.
- Gather supporting documentation and evidence for investigations.
- Track action items and follow up with stakeholders to support timely completion.
- Support quality event trending and reporting.
- Assist with supplier qualification and monitoring activities and organize supplier documentation.
- Track supplier corrective action requests and follow-up activities.
- Prepare supplier performance reports and quality metrics for review.
- Assist with preparation for internal, supplier, customer, and regulatory audits; collect and organize requested documentation.
- Track audit commitments and follow-up actions, and help maintain inspection readiness.
- Compile quality data for management reporting and support dashboards, scorecards, and trend analyses.
- Maintain tracking tools used to monitor quality performance and communicate status updates to team members and stakeholders.
- Participate in quality improvement projects and initiatives, identify opportunities to improve quality processes, and support implementation of process improvements.
- Contribute to a culture of continuous improvement and compliance.
Benefits
- Medical, dental, and vision coverage
- 401(k)
- Life, accident, and disability insurance
- Wellness programs
- Eligible roles may include a bonus and long-term incentive as part of the total rewards package
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
No Education Listed
