The role requires collaborating with cross-functional teams to resolve complex quality issues while ensuring adherence to global GMP regulations
Job Summary
The role requires collaborating with cross-functional teams to resolve complex quality issues while ensuring adherence to global GMP regulations.
Candidates will lead investigations, root cause analyses, and corrective action plans for deviations and operational inefficiencies within the medical device sector.
Vertex offers a competitive salary range, annual bonuses, equity awards, and comprehensive benefits including student loan repayment and flexible hybrid work options.
Matching Summary
The role requires collaborating with cross-functional teams to resolve complex quality issues while ensuring adherence to global GMP regulations.
Salary
Base: $109,600 - $164,400; Bonus/Equity: Eligible for annual bonus and equity awards; Benefits: Medical, dental, vision, 401(k), paid time off, educational assistance
Skills & Requirements
Must-have
5 years experience in quality systems
3 years medical devices field experience
Knowledge of 21 CFR Parts 4 and 820
ISO 13485 and ISO 14971 compliance
Root cause analysis and CAPA leadership
Veeva electronic management system experience
Lean Six Sigma continuous improvement
Nice-to-have
Power BI data analysis skills
Cross-functional team collaboration
Project management expertise
Training curriculum development
Risk mitigation planning
Key Requirements
Bachelor's degree in Engineering or Life Sciences
Minimum 5 years total experience in Quality Systems
Minimum 3 years specific medical device industry experience
In-depth knowledge of cGMPs in medical device settings