This role serves as a subject matter expert in ISO 9001:2015 and manufacturing quality controls to ensure compliance while driving operational excellence
Job Summary
This role serves as a subject matter expert in ISO 9001:2015 and manufacturing quality controls to ensure compliance while driving operational excellence.
The position involves leading the internal audit program, driving systemic corrective actions, and partnering with Operations and Engineering to embed quality into production processes.
Candidates are offered a comprehensive Total Rewards package including medical plans, paid time off, retirement savings, and an Employee Stock Purchase Plan.
Matching Summary
This role serves as a subject matter expert in ISO 9001:2015 and manufacturing quality controls to ensure compliance while driving operational excellence.
Salary
Base: $83,300.00–$115,000.00; Bonus/Equity: Variable annual bonus based on performance; Benefits: Comprehensive medical, dental, vision, 401(k), and ESPP
Skills & Requirements
Must-have
ISO 9001:2015 QMS implementation
Internal and external audit execution
CAPA and deviation management expertise
Root cause analysis and investigation
Statistical analysis and data trending
Manufacturing environment PPE usage
Nice-to-have
Cross-functional team collaboration skills
Project management experience preferred
Risk assessment methodology knowledge
Continuous improvement tool proficiency
Strong technical writing capabilities
Key Requirements
Bachelor's Degree plus 5 years experience or Advanced Degree plus 3 years
Experience in regulated industries like pharmaceutical or biotech
Demonstrated expertise in root cause analysis techniques
Proficiency with quality systems software and MS Office Suite