Senior Quality Engineer (CAPA)

TL;DR

Senior Quality Engineer (CAPA): Leading and supporting activities to ensure QMS compliance with an accent on the Corrective and Preventive Action (CAPA) process. Focus on driving cross-functional problem-solving teams, conducting root cause analysis, and ensuring audit readiness of CAPA records.

Location: Hybrid, must be based in or report to Wayne, NJ

Salary: $115,000 – $130,000

Company

hirify.global provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows.

What you will do

• Lead cross-functional problem-solving teams to maintain timeliness of CAPA activities and documentation.
• Guide CAPA owners through investigation, root cause analysis, action planning, and effectiveness checks.
• Oversee QMS compliance in accordance with ISO 13485, FDA 21 CFR Part 820, and other relevant regulations.
• Conduct internal audits and manage external audits to ensure regulatory compliance.
• Develop and monitor quality metrics to assess the performance of the QMS and CAPA processes.
• Prepare and maintain critical documentation, including quality manuals, SOPs, and work instructions.

Requirements

• Bachelor’s Degree in engineering, Science, or a related field.
• Minimum of 5 years hands-on experience with management of CAPAs and the CAPA process.
• Strong understanding of QMS principles and CAPA methodologies.
• Proficiency with Microsoft Office tools (Word, Excel, PowerPoint).
• Must be able to work from the Wayne, NJ headquarters (Hybrid: 1-2 days from home).

Nice to have

• Master of Science in Engineering or Science.
• ASQ Certified Quality Auditor (CQA) and/or Certified Quality Engineer (CQE).
• Experience with TrackWise electronic CAPA management programs.
• Familiarity with Minitab analytical software applications.

Culture & Benefits

• Hybrid work arrangement with 1-2 days of remote work per week.
• Annual bonus of 10%.
• Professional development opportunities within a diverse, global team.
• Focus on creating life-saving technology accessible for more people.