Quality Engineer

This is a fully remote position, open to applicants in United States.

📋 Description

• Assist with internal and external audits (CLIA/CAP, ISO 13485, and customer audits).

• Aid in CAPA, Deviation, Change Requests, and Nonconformance investigations and reporting.

• Draft and update procedures and forms as necessary.

• Conduct statistical analyses and hypotheses testing (AQLs, etc.) as required.

• Ensure compliance with Quality systems regarding CLIA, FDA QSR, ISO 13485, and HIPAA.

• Engage in the management of Approved Suppliers.

• Adhere to established company standard operating procedures and maintain good documentation practices.

• Review manufacturing and QC batch records.

• Perform other duties as assigned.

⛳️ Requirements

• Bachelor’s degree or equivalent in science, engineering, or a related field.

• Minimum of 4 years of experience in the medical diagnostics, CLIA laboratory, or Life Sciences industry; 2 years of experience in a Quality role is preferred.

• Experience in auditing, including internal audits, third-party audits, and/or regulatory audits.

• American Society of Quality certifications (CQE) are preferred.

🏝️ Benefits

• Comprehensive medical, dental, vision, life, and disability plans for eligible employees and their dependents.

• Complimentary testing for employees and their immediate family members.

• Fertility care benefits available.

• Leave for pregnancy and baby bonding.

• 401k benefits provided.

• Commuter benefits offered.

• Generous employee referral program.