We’re a company of agile, customer-oriented individuals with a shared commitment to integrity, servant leadership, and teamwork. Our associates take pride and ownership in their work, and innovate to provide the highest quality, life-enhancing medical technology in the world. Together, We’re in It for Life.
Requirements
- Support and uphold Viant Values: Customer Oriented, Integrity, Servant Leadership, Own It, Teamwork, and Be Agile.
- Provide strategic leadership for all quality assurance and regulatory programs, ensuring continuous improvement and compliance with FDA, ISO 13485, and customer requirements.
- Lead the design, implementation, and maintenance of systems for document control, training, corrective and preventive action, discrepancy handling, complaint handling, product release, and environmental monitoring.
- Review and approve quality system documentation; develop and maintain procedures for QA and regulatory functions.
- Collaborate with plant leadership and corporate quality to drive adherence to processes and achieve KPIs.
- Manage quality engineering support and indirect inspection teams to improve efficiency and resolve root causes.
- Interact with customers and suppliers on all quality matters, ensuring strong relationships and satisfaction.
- Handle direct selection, training, and development of quality personnel; coach and mentor team members.
- Oversee internal/external audits, CAPA programs, and implement corrective actions to improve product quality.
- Communicate and act on revisions, validations, and quality-related requirements; ensure robust QMS and customer satisfaction.
- Manage and communicate all quality-related information, including revisions, validations, audits, and customer requirements.
- Interpret and implement corrective actions to address product quality issues as requested by customers.
- Maintain a robust Quality Management System that meets all FDA, ISO 13485 and customer requirements.
- Perform other duties as needed
Benefits
- Medical, dental, and vision benefits
- Company-paid life insurance and disability benefits
- Generous Paid time off and 10 paid Holidays
- 401k Plan with Company Match
- Tuition Reimbursement
- Voluntary Universal Life and Long-Term Care
- Voluntary Legal Plan
- Pet Insurance
- Home Ownership Program
