QA Specialist, Medical Devices & Regulatory Compliance

Stratix Corporation; Peachtree Corners (GA); On-site; USD 60,000 - 90,000; Full time

Job summary

Stratix Corporation seeks a Quality Assurance Specialist to ensure provisioning, configuration, and kitting of medical devices meet regulatory and customer requirements. The role enforces quality systems, supports risk assessment, CAPA, and documentation practices on the production floor.

The ideal candidate has a bachelor’s degree in a related field and at least 2 years of QA experience in regulated manufacturing, with strong RCA and CAPA skills and a focus on data integrity and HIPAA/medical

Qualifications

• Bachelor’s degree in a related field or equivalent experience.
• Minimum 2 years in quality assurance in regulated manufacturing.
• Experience with RCA, CAPA, and quality documentation.
• Knowledge of medical device regulations and compliance frameworks.
• Strong attention to detail and data integrity.

Responsibilities

• Provide quality oversight of provisioning, configuration, and kitting operations.
• Ensure compliance with ISO 13485, ISO 9001, and QSR requirements.
• Create and maintain DHRs/DMRs, batch records, and related docs.
• Support risk management, FMEA, and CAPA activities.
• Train production personnel on quality standards and SOPs.

Skills

RCA

CAPA

Quality documentation

Data integrity

Regulatory knowledge

Cross-functional collaboration

Education

Bachelor’s degree in Quality/Engineering/Life Sciences

Tools

PPAP

CoC

Supplier quality controls

Job description

Stratix Corporation seeks a Quality Assurance Specialist to ensure provisioning, configuration, and kitting of medical devices meet regulatory and customer requirements. The role enforces quality systems, supports risk assessment, CAPA, and documentation practices on the production floor.

The ideal candidate has a bachelor’s degree in a related field and at least 2 years of QA experience in regulated manufacturing, with strong RCA and CAPA skills and a focus on data integrity and HIPAA/medical