Overview
Director Quality Operations Jobs in Lawrence, USA at Weber & Company
The Director of Quality Operations will lead quality strategy and operational execution for an exciting fast-paced, high-growth medical device company. This role is responsible for ensuring the consistent delivery of safe, compliant, and high-quality products while driving operational excellence across quality systems, manufacturing quality, supplier quality, and regulatory compliance activities.
The successful candidate will thrive in a dynamic environment, partnering cross-functionally to scale quality operations, support business growth, and maintain compliance with FDA QSR, ISO 13485, MDR, and other global regulations.
Key Responsibilities
- Lead and continuously improve the Quality Management System (QMS) to ensure global regulatory compliance.
- Oversee manufacturing quality, supplier quality, CAPA, audits, nonconformance management, and inspection readiness activities.
- Serve as the quality lead during FDA inspections, notified body audits, and customer audits.
- Drive a culture of continuous improvement using Lean and Six Sigma methodologies.
- Partner closely with Operations, Supply Chain, Regulatory Affairs, and R&D to support rapid growth and operational scalability.
- Establish and monitor KPIs to improve product quality, operational efficiency, and compliance performance.
- Build, mentor, and develop high-performing quality teams in a fast-moving environment.
Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Quality, Operations, or related field.
- 10+ years of quality experience within medical devices or other highly regulated industries.
- 5+ years of leadership experience in fast-paced manufacturing or operational environments.
- Strong working knowledge of FDA QSR (21 CFR Part 820), ISO 13485, MDR, and global quality regulations.
- Proven experience leading audits, quality improvement initiatives, and supplier quality programs.
- Strong leadership, communication, and problem-solving skills with the ability to operate effectively in a high-growth environment.
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Title: Director Quality Operations
Company: Weber & Company
Location: Lawrence, USA
Category:
