P3P3 — Mid-Level Professional
Research & Development / Quality Assurance Specialist
Ensures product design controls and development activities comply with regulatory standards.
What this level means
Fully competent professional; works independently on standard projects
- Scope
- Features or a sub-system end-to-end
- Autonomy
- Works independently on standard work; reviewed on the non-standard
- Complexity
- Diverse problems; adapts existing approaches
- Impact
- Project / team outcomes
- Decision rights
- Owns implementation decisions for own scope
- Leadership
- Mentors juniors informally
- Typical experience
- 3–5 yrs
What you'd do
- Design Control Oversight
- Risk Management
- Document Control & Records
- Procedure and SOP Development
- Training & Guidance
- Internal Audits & Readiness
- Ensure compliance with regulatory standards
- Coordinate with R&D teams to integrate quality processes
- Conduct quality reviews and assessments
- Develop and implement quality assurance strategies
- Oversee design control processes
- Manage risk assessments
- Maintain document control systems
- Develop SOPs and training materials
- Conduct internal audits
Skills, knowledge & tools
- Quality management
- Regulatory compliance
- Process documentation
- Risk assessment
- Training development
- Audit preparation
- Communication
- Problem-solving
- Quality assurance principles
- Regulatory standards
- Design control processes
- Risk management frameworks
- SOP development
- Audit procedures
- Product development lifecycle
- Medical product regulations
- Detail-Oriented
- Strong communication
- Problem-solving mindset
- Regulatory compliance
- Quality assurance expertise
- Process improvement
- Analytical skills
- Collaboration
What good looks like
- Bachelor’s degree in Engineering, Life Sciences or a related field
- 3–6 years of experience in quality assurance
- Advanced degree in Quality Management or Regulatory Affairs preferred
- ASQ Certified Quality Engineer (CQE) preferred
- Proven track record in quality assurance
Common titles
Research & Development / Quality Assurance Specialist
What it pays
Market-pay benchmarks for this family × level are being recalibrated across all survey sources and will return shortly.
O*NET / SOC: 19-0000 — Life, Physical, & Social Science Occupations (inferred)