Quality Specialist I
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Apply Now Application ends in 27d 14h 11min
Job Detail
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Offered Salary 0
Job Description
Position Summary
The Quality Specialist I is an entry-level quality assurance and compliance role that supports day-to-day quality system activities in a regulated environment. This individual plays a key role in ensuring that Noxilizer’s products, services, and operations meet internal quality standards and comply with applicable regulations, including ISO 13485, FDA 21 CFR Part 820, and other relevant industry guidelines.
This role is ideal for someone detail-oriented, organized, and eager to grow their career in quality assurance within the life sciences or medical device industry.
Key Responsibilities:
- Assist in the maintenance and improvement of the company’s Quality Management System (QMS), including document control, training records, CAPAs, NCRs, and change controls
- Support internal audits, customer audits, and regulatory inspections through preparation and participation
- Perform review of batch records, quality documentation, and production reports to ensure compliance and accuracy
- Participate in deviation investigations, root cause analysis, and implementation of corrective and preventive actions (CAPA)
- Support the management of controlled documents such as SOPs, forms, quality policies, and specifications
- Coordinate quality-related training activities and maintain accurate training records for all departments
- Track and trend quality metrics and provide periodic reports to Quality leadership
- Monitor calibration and preventive maintenance schedules to ensure timely completion
- Work closely with manufacturing, R&D, and operations teams to ensure quality is integrated into all processes
- Maintain up-to-date knowledge of regulatory changes and quality system best practices
Qualifications:
- Associate’s or Bachelor’s degree in Life Sciences, Biology, Chemistry, Engineering, or related field (required)
- 0–2 years of experience in a regulated environment (pharma, biotech, medical device preferred)
- Understanding of basic quality principles, cGMP, ISO 13485, and/or FDA 21 CFR Part 820 (training will be provided)
- Strong attention to detail and organizational skills
- Excellent written and verbal communication skills
- Ability to handle multiple tasks, prioritize effectively, and work independently or as part of a team
- Proficiency in Microsoft Office Suite (Word, Excel, Outlook, PowerPoint)
Preferred Qualifications
- Prior internship or co-op experience in Quality Assurance or Regulatory Affairs
- Familiarity with electronic QMS tools and document control software
- Experience participating in audits or regulatory inspections
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Application ends in 27d 14h 11min