Senior Quality Engineer

Planet Pharma; Draper (UT); On-site; USD 110,000 - 140,000; Full time

Job summary

Planet Pharma seeks a CAPA Engineer to own end-to-end CAPA processes from issue assessment to effectiveness checks in a regulated medical device environment. You will lead structured investigations and ensure compliant documentation within the eQMS, partnering with Manufacturing, R&D, and QA teams to implement corrective actions.

The role requires a Bachelor's degree in engineering and experience with ISO 13485:2016 and FDA 21 CFR 820.100.

Qualifications

• Bachelor's degree in engineering is required.
• Experience with ISO 13485:2016 and FDA 21 CFR 820.100 preferred.
• Strong technical writing and investigation/reporting skills.

Responsibilities

• Lead CAPA investigations and closure per regulatory requirements.
• Draft high-quality CAPA investigation reports and documentation.
• Ensure eQMS entries are complete, traceable, and data-integrity compliant.
• Support updates to SOPs, work instructions, forms, DHRs, and inspection methods.
• Collaborate with Manufacturing, Operations, R&D, and Supplier Quality on corrective actions.
• Define and execute effectiveness checks using statistical methods and trend analysis.
• Present status at the CAPA Review Board.

Skills

CAPA management

Root cause analysis

5 Whys

Ishikawa

8D DMAIC

Quality systems

Statistics

Education

Bachelor's degree in engineering

Tools

TrackWise

Agile

Veeva

Job description

Take personal ownership of assigned individual CAPAs and all related processing - from issue assessment and containment through root cause, action plan execution, implementation verification, and effectiveness check closure - in compliance with ISO 13485:2016 (Clauses 8.5.2/8.5.3) and 21 CFR 820.100.

Support overall CAPA process acceleration: drive assigned records to committed due dates, reduce cycle time and aging, escalate blockers early, and hold cross-functional task owners accountable.

Lead structured root cause investigations using 5 Whys, Fishbone/Ishikawa, Fault Tree Analysis, and 8D/DMAIC, documenting conclusions with clear, defensible technical rationale.

Author high-quality investigation reports and CAPA documentation that withstand FDA, Notified Body, and internal audit scrutiny - strong technical writing is a core requirement of this role.

Ensure documentation compliance across all assigned records: complete, accurate, traceable, and contemporaneous entries in the eQMS, with full data integrity and GDP adherence.

Support Quality System updates and modifications, including revisions to SOPs, work instructions, forms, DHRs, and inspection methods resulting from CAPA actions.

Partner with Manufacturing, Operations, R&D, and Supplier Quality on the floor to implement corrections and corrective/preventive actions, and confirm actions do not adversely affect finished product or patient safety.

Define and execute effectiveness check methodology, applying statistical techniques and trend analysis of NC, complaint, and audit data to confirm sustained resolution; present record-level status at the CAPA Review Board.

Preferred: eQMS experience (TrackWise, Agile, Veeva, or equivalent), Class II/III implantable or combination device experience, CQE/CQA.

Education/Experience:

• Bachelor's degree in engineering required.