Senior QA Engineer II — Medical Devices (Onsite Clinic)

Merit Medical Systems; Pearland (TX); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Onsite medical clinic

Onsite cafeterias

Paid time off

Job summary

Merit Medical Systems in Pearland, TX seeks a Senior Quality Assurance Engineer II to independently evaluate and apply standard engineering techniques across product lines. You will manage risk, approve ECNs, and drive CAPA actions to ensure quality system effectiveness.

Requirements include a Bachelor's in Engineering and 3+ years of quality engineering, with working knowledge of 21 CFR 820, ISO 13485 and related standards. Experience with supplier audits and CAPA handling is preferred.

Qualifications

• Bachelor's Degree in Engineering or related field required.
• 3+ years quality engineering experience.
• Knowledge of 21 CFR 820, ISO 13485, ISO 14791 and other medical device standards.

Responsibilities

• Evaluate and apply standard engineering techniques to assigned product lines.
• Manage risk documentation and drive CAPA planning and corrective actions.
• Review and approve ECNs and update verification/validation methods and test protocols.
• Participate in supplier quality management and audits as needed.
• Ensure containment of nonconforming product and maintain quality system effectiveness.

Education

Bachelor's Degree in Engineering

Tools

SmartCAPA

Oracle

Crystal Reports

Job description

Merit Medical Systems in Pearland, TX seeks a Senior Quality Assurance Engineer II to independently evaluate and apply standard engineering techniques across product lines. You will manage risk, approve ECNs, and drive CAPA actions to ensure quality system effectiveness.

Requirements include a Bachelor's in Engineering and 3+ years of quality engineering, with working knowledge of 21 CFR 820, ISO 13485 and related standards. Experience with supplier audits and CAPA handling is preferred.