Sr Engineer

Hydrogen Group; Draper (UT); On-site; USD 110,000 - 150,000; Full time

Job summary

Hydrogen Group is seeking an experienced CAPA/Quality professional to own CAPAs from issue assessment through closure in a regulated medical device environment. You will lead structured root cause investigations and author comprehensive reports meeting FDA and Notified Body requirements.

Responsibilities include ensuring GDP-compliant eQMS documentation, supporting quality system updates, and partnering with Manufacturing, Operations, R&D, and Supplier Quality to verify corrective actions and

Qualifications

• Bachelor's degree in Engineering is required.
• 5-7 years of relevant professional experience.
• Experience managing CAPAs and conducting structured root cause investigations.
• Strong technical writing and quality system documentation skills.
• Knowledge of ISO 13485:2016 and 21 CFR 820.100.

Responsibilities

• Take ownership of CAPAs from issue assessment to closure per ISO 13485:2016 and CFR 21 CFR 820.100.
• Lead root cause investigations using 5 Whys, Fishbone, Fault Tree Analysis, and 8D/DMAIC with clear rationale.
• Prepare CAPA reports and documentation for FDA audits and internal audits.
• Ensure records are complete, traceable, and GDP-compliant in the eQMS.
• Collaborate with Manufacturing, Operations, R&D, and Supplier Quality to implement corrective actions.
• Define and execute effectiveness checks using statistics and trend analysis.
• Present CAPA status at CAPA Review Board meetings.

Skills

CAPA management

Root cause investigations

Technical writing

Quality system documentation

ISO 13485 familiarity

21 CFR 820.100 familiarity

Implantable devices experience

Education

Bachelor's degree in Engineering

CQE or CQA certification

Tools

TrackWise

Veeva

Agile

Job description

• Take ownership of assigned CAPAs and all related activities, from initial issue assessment and containment through root cause investigation, action plan execution, implementation verification, effectiveness checks, and closure, in accordance with ISO 13485:2016 (Clauses 8.5.2/8.5.3) and 21 CFR 820.100.
• Support CAPA process acceleration by driving assigned records toward committed due dates, reducing cycle time and aging, escalating blockers promptly, and ensuring cross-functional task owners complete assigned actions.
• Lead structured root cause investigations using methodologies such as 5 Whys, Fishbone/Ishikawa, Fault Tree Analysis, and 8D/DMAIC, documenting conclusions with clear and defensible technical rationale.
• Author comprehensive investigation reports and CAPA documentation designed to meet FDA, Notified Body, and internal audit requirements. Strong technical writing skills are essential.
• Ensure assigned records are complete, accurate, traceable, and contemporaneously documented within the electronic Quality Management System (eQMS), maintaining data integrity and Good Documentation Practices (GDP).
• Support Quality System updates resulting from CAPA activities, including revisions to SOPs, work instructions, forms, Device History Records (DHRs), and inspection methods.
• Partner cross-functionally with Manufacturing, Operations, R&D, and Supplier Quality to implement corrections and corrective/preventive actions and verify that changes do not adversely affect finished product or patient safety.
• Define and execute effectiveness-check methodologies, applying statistical techniques and trend analysis of nonconformance, complaint, and audit data to confirm sustained resolution.
• Present CAPA record status and progress during CAPA Review Board meetings.

Qualifications

Required:

• Bachelor's degree in Engineering.
• 5-7 years of relevant professional experience.
• Experience managing CAPAs and conducting structured root cause investigations.
• Strong technical writing and Quality System documentation skills.
• Knowledge of ISO 13485:2016 and 21 CFR 820.100.

Preferred:

• Experience with an eQMS platform such as TrackWise, Agile, Veeva, or equivalent.
• Experience supporting Class II/III implantable or combination medical devices.
• Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) certification.