Experience Required: Minimum 3 Years
Education: Bachelor’s Degree Preferred
We are seeking a detail-oriented and experienced Quality Assurance Specialist to support quality operations and compliance initiatives in a regulated environment. This individual contributor role requires sound professional judgment, the ability to work independently with minimal supervision, and a strong understanding of quality systems, regulatory compliance, and process improvement.
The ideal candidate will have hands-on experience implementing quality standards, supporting audits and inspections, and ensuring compliance throughout all stages of operational and production processes.
This position is an on-site office position. Must live in the local area.
Key Responsibilities
-
Implement and maintain quality standards across all stages of the process
-
Ensure compliance with internal procedures, regulatory requirements, and quality systems
-
Assess potential quality and compliance risks and provide recommendations for mitigation
-
Take ownership of quality control activities related to:
-
Service Processes
-
Testing and operations
-
Production processes
-
Finished products and services
-
Facilitate internal audits and regulatory inspections
-
Coordinate and support quality training initiatives
-
Apply professional expertise and independent judgment to resolve quality-related issues
-
Collaborate cross-functionally to drive continuous improvement and compliance excellence
Qualifications
-
Bachelor’s degree preferred or equivalent in experience
-
Minimum of 3 years of relevant quality assurance or quality control experience
-
Strong understanding of quality systems, compliance standards, and regulated environments
-
Experience supporting audits and regulatory inspections
-
Ability to work independently with minimal supervision
-
Strong analytical, organizational, and communication skills
-
Practical knowledge gained through hands-on industry experience preferred
Preferred Skills
-
Experience in medical device, pharmaceutical, biotech, or healthcare environments
-
Familiarity with GMP, GLP, GCP, FDA, or ISO standards
-
Strong problem-solving and risk assessment capabilities
