Why This Role ExistsThis is a hands-on Quality Systems leadership role responsible for owning and evolving our ISO 9001 Quality Management System (QMS). This role is critical to how we scale ensuring quality systems remain strong, consistent, and able to support increasing operational and customer demands without relying on reactive problem-solving.
What You'll OwnQuality System Ownership & Audit Readiness- Own and continuously improve the ISO 9001 Quality Management System
- Maintain audit readiness across internal, customer, and third-party audits
- Manage document control (SOPs, Work Instructions) and training alignment
- Track and report weekly quality metrics and trends
- Ensure systems remain aligned with how work is carried out
Nonconformance, CAPA & Root Cause- Lead the Material Review Board (MRB) for nonconforming materials
- Own nonconformance investigations from initiation through closure (internal and customer)
- Strengthen and standardize the CAPA system
- Drive structured root cause analysis (5 Whys, Fishbone, etc.)
- Manage quarantine inventory and material disposition
- Close Supplier Corrective Action Requests (SCARs)
Change Control & Governance- Lead Change Review Board (CRB) and change control governance
- Implement and maintain a risk-based change control framework
- Ensure consistent application across teams and functions
Supplier Quality- Develop supplier qualification and performance programs
- Implement risk-based supplier segmentation and monitoring
- Partner cross-functionally to resolve supplier quality issues
Data Integrity & Documentation Systems- Improve SDS (Safety Data Sheet) lifecycle management and governance
- Ensure alignment across SDS, CoA, specifications, and internal records
- Establish standards for data integrity, traceability, and GHS compliance
Operational Quality Programs- Manage equipment calibration program (no overdue items)
- Oversee chemical disposal program and vendor coordination
What You Bring- 5-10+ years in Quality Systems / QA (chemical, pharma, or regulated manufacturing)
- Experience leading or developing a small team
- Strong working knowledge of ISO 9001 (cGMP familiarity preferred)
- Experience building or improving CAPA, change control, audits, or supplier quality systems
- Comfortable leading cross-functional governance forums (MRB, CRB, or similar)
- Degree in Chemistry, Chemical Engineering, or related field (or equivalent experience)
- ASQ certification (CMQ/OE, CQA) a plus
What Success Looks Like- A structured, scalable, consistently applied QMS
- Strong audit readiness with minimal reactive fixes
- Effective CAPA and change control systems with clear ownership
- Nonconformances and SCARs closed on time with root cause resolution
- Improved supplier accountability and visibility
- Reliable, consistent quality data and documentation
Why Join Us- Direct ownership of the quality system at a growing company
- Opportunity to build structure during a key scaling phase
- High visibility and collaboration with leadership
- Real impact on how the business operates as it grows
Compensation$100,000 - $130,000 base salary + target 7% annual performance bonus (based on individual and company performance)
Benefits- Medical, Dental, and Disability Insurance
- 401(k) with company match
- Paid Time Off
