Senior Engineer I – QA Design
Artex Risk Solutions
Senior Manager, Supplier Quality and Quality Management Systems
CellCarta
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteSalary
💰 $90,000 - $105,000 per year
Job Level
Senior
About the role
- Lead the development and execution of supplier quality strategies, ensuring alignment with corporate quality objectives and regulatory requirements.
- Oversee supplier performance, risk management, and compliance.
- Lead comprehensive supplier assessments, including risk evaluations, audits, and qualification questionnaires.
- Serve as the primary interface with corporate suppliers, fostering strategic partnerships and ensuring alignment with quality expectations.
- Maintain and negotiate quality agreements.
- Plan, execute, and oversee supplier audits, ensuring thorough documentation and follow-up.
- Contribute to the development and implementation of a robust third-party IT vendor management program.
- Maintain and enhance systems for managing supplier complaints and SCARs.
- Participate in ISO certification audits, including ISO 27001 and ISO 13485.
- Serve as a subject matter expert on Quality Management Systems; perform and support QA review of CSV deliverables related to CellCarta systems.
- Collaborate across business units to develop harmonized policies, procedures, and work instructions.
- Lead initiatives to standardize key quality system SOPs.
- Partner with internal stakeholders to identify and implement process improvements that enhance quality system performance.
- Manage and update corporate documents, including corporate supplier management materials, to present in management reviews.
Requirements
- Minimum BA/BS in science or health-related discipline.
- Minimum of 5 years’ experience managing supplier quality systems.
- Specific experience in managing supplier quality and performing CSV reviews (preferred).
- Two years of audit experience is preferred.
- Knowledge of GCLP, GMP, and global regulatory frameworks.
- Proficiency in ISO 13485, ISO 15189, and CAP/CLIA requirements.
- Lead supplier quality alignment initiatives, including development and negotiation of quality agreements.
- Knowledge of compliance requirements for different stages of development and applicable global regulations.
- Exceptional written and verbal communication skills.
- Influence cross-functional teams; excellent project management skills.
- Experience reviewing CSV documentation is preferred.
