Senior Quality Engineer, CAPA (Wayne, NJ)
$115,000–$130,000 year
Hybrid · Wayne, New Jersey, United States
Job Summary
Senior Quality Engineer to lead CAPA and QMS compliance for Cardiac Assist, driving CAPA investigations, root-cause analysis, TrackWise management, audits, and continuous improvement in ISO 13485/FDA-regulated environment. Hybrid role based in Wayne, NJ, with 1-2 days remote per week, reporting to the Wayne headquarters. The role emphasizes CAPA initiation and tracking, CAPA ownership support, audit preparation, development of quality metrics, and documentation upkeep (SOPs, quality manuals) while collaborating across departments.
Required Qualifications
- Bachelor’s Degree in engineering, Science, or a related field is required
- Minimum 5 years hands-on experience with management of CAPAs and CAPA process is required
- ASQ Certified Quality Auditor (CQA) and/or Certified Quality Engineer (CQE) or an equivalent is preferred
- Experience with electronic CAPA management programs (TrackWise) is preferred
- Excellent understanding of QMS principles and CAPA methodologies
- Strong analytical and problem-solving skills with a focus on root cause analysis and corrective actions
- Effective communication and interpersonal skills, with the ability to work collaboratively across departments
- Proficiency with quality management software and tools
- Working knowledge of quality systems; familiarity with Minitab preferred
- Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, or equivalent)
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