Manager, Quality Operations
Position Summary
The Manager of Quality Operations will support quality strategy and day-to-day operational quality activities for a fast-paced, high-growth medical device company. This role is responsible for ensuring product quality, regulatory compliance, and continuous improvement across manufacturing quality, supplier quality, and quality systems processes.
The successful candidate will work cross-functionally to maintain compliance with FDA QSR, ISO 13485, MDR, and other applicable regulations while driving operational efficiency and supporting business growth.
Key Responsibilities
- Support the maintenance and continuous improvement of the Quality Management System (QMS).
- Manage quality operations activities including CAPA, nonconformance management, change control, audits, and supplier quality.
- Partner with Manufacturing, Supply Chain, Regulatory Affairs, and R&D to resolve quality issues and improve processes.
- Support FDA inspections, notified body audits, and customer audits, ensuring inspection readiness.
- Drive continuous improvement initiatives using Lean and problem-solving methodologies.
- Monitor and report quality KPIs, identify trends, and implement corrective actions.
- Lead and develop quality team members while promoting a strong culture of quality and compliance.
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Quality, Operations, or related field.
- 5+ years of quality experience within medical devices or other regulated industries.
- Prior leadership or supervisory experience preferred.
- Strong knowledge of FDA QSR (21 CFR Part 820), ISO 13485, MDR, and quality systems requirements.
- Experience supporting audits, supplier quality activities, and manufacturing quality operations.
- Strong communication, organizational, and problem-solving skills with the ability to thrive in a fast-paced environment.
