P2P2 — Developing Professional
QA Engineer II
Independently performs design verification tasks, validation protocols, and supplier audits for low-to-moderate complexity items.
What this level means
Early-career professional; developing skills, handles routine tasks with some independence
- Scope
- Defined deliverables / small features
- Autonomy
- General supervision; reviewed at milestones
- Complexity
- Some non-routine problems; applies established patterns
- Impact
- Own and immediate-team deliverables
- Decision rights
- Routine technical choices within guidance
- Leadership
- May guide interns
- Typical experience
- 1–3 yrs
What you'd do
- Design verification tasks
- Validation protocols
- Supplier audits
- Ensure compliance with ISO 13485/21 CFR 820
- Analyze test results and report findings
- Participate in cross-functional teams
- Support process improvement initiatives
- Conduct training for junior staff
- Prepare audit reports
- Maintain supplier quality records
- Perform design verification
- Conduct supplier audits
- Develop validation protocols
Skills, knowledge & tools
- Design verification
- Validation protocol development
- Supplier auditing
- Analytical thinking
- Technical documentation
- Process analysis
- Regulatory compliance
- Team collaboration
- ISO 13485 standards
- 21 CFR 820 regulations
- Design verification processes
- Validation techniques
- Supplier quality management
- Analytical methods
- Process improvement strategies
- Technical writing
- Proficient with ISO 13485/21 CFR 820 requirements
- Strong analytical skills
- Attention to detail
- Process improvement
- Supplier management
- Technical writing
- Training and mentoring
- Regulatory compliance
What good looks like
- 2–5 years in QA/QE roles
- Proficiency in ISO 13485/21 CFR 820
- Strong analytical skills
Common titles
QA Engineer II
What it pays
Market-pay benchmarks for this family × level are being recalibrated across all survey sources and will return shortly.
O*NET / SOC: 51-0000 — Production Occupations (inferred)