Quality Engineer

Quality Senior Engineer I

We are seeking a Quality Senior Engineer I to support CAPA remediation, quality system compliance, and continuous improvement initiatives within a regulated medical device environment. This role is responsible for reviewing and remediating legacy CAPA records, driving quality investigations, ensuring compliance with FDA and ISO standards, and partnering cross‑functionally to improve product quality and regulatory compliance.

• Review, remediate, and migrate legacy CAPA records into the EtQ Quality Management System.
• Manage CAPAs from initiation through investigation, action tracking, effectiveness verification, and closure.
• Perform gap assessments and correct documentation deficiencies to meet regulatory and internal quality requirements.
• Partner with Quality, Regulatory, Engineering, Manufacturing, and Operations to support CAPA execution and remediation.
• Support compliance with global CAPA procedures, documentation standards, and record retention requirements.
• Assist with user training and guidance on CAPA processes and EtQ.

• Bachelor's degree in Engineering or a related technical field.
• 3–5 years of Quality Engineering experience, preferably within the medical device industry.
• Experience with CAPA, root cause analysis, FMEA, risk management, and quality investigations.
• Working knowledge of FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and ISO 14971.
• Experience using electronic Quality Management Systems (EtQ preferred).
• Strong technical writing, documentation review, analytical, and problem‑solving skills.
• Certified Quality Engineer (CQE) and orthopedic medical device experience are a plus.

If you're passionate about improving quality systems, driving compliance, and partnering across teams to resolve complex quality challenges, we'd love to hear from you!

We are an Equal Opportunity Employer committed to Diversity & Inclusion and incorporate non‑discrimination best practices in all our staffing processes. Mainz Brady Group does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, gender expression, age, disability, or any other protected class.