We are seeking a talented and driven Quality Leader to oversee all Quality Systems and activities across our organization. This individual will be responsible for developing the quality team, strengthening our systems and processes, and ensuring compliance with ISO 13485, FDA 21 CFR Part 820, MDSAP, and other global regulatory standards.

As a key leader in our organization, you will work closely with cross-functional teams—R&D, Manufacturing, Regulatory Affairs, Supply Chain, Sales, etc.. to maintain a robust Quality Management System (QMS) and foster a culture of continuous improvement and operational excellence.

Key Responsibilities:

• Lead, mentor, and develop the Quality team; provide direction, coaching, and performance management to ensure team success.

• Define and execute the company-wide quality strategy, aligning quality objectives with business goals and regulatory expectations.

• Oversee the development, implementation, and maintenance of the Quality Management System (QMS) to meet ISO 13485, FDA, and other applicable standards.

• Ensure continued certification of QMS (ISO 13485, MDSAP) through successful management of internal and external audits and inspections.

• Monitor and report on quality performance metrics, drive data-based improvements, and lead CAPA (Corrective and Preventive Actions) initiatives.

• Lead risk management activities across the product lifecycle, including FMEA, fault tree analysis, and other quality tools.

• Support design control and product development processes to ensure manufacturability, compliance, and quality integration from concept to production.

• Manage the validation and verification of products and manufacturing processes with proper documentation and compliance oversight.

• Oversee handling of non-conformances, customer complaints, and field returns, ensuring timely resolution and root cause analysis.

• Maintain strong relationships with regulatory agencies, suppliers, customers, and external partners to ensure product quality and compliance.

• Promote and implement lean manufacturing, Six Sigma, and other continuous improvement methodologies to enhance product quality and reduce cost of poor quality.

• Collaborate with Regulatory Affairs to support domestic and international regulatory submissions and audits.

• Manage budgets related to quality operations and track financial metrics tied to quality performance and compliance.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related field (Master’s or advanced certifications preferred).

• 8+ years of experience in Quality roles, with 3+ years in a leadership capacity in the medical device industry.

• Strong knowledge of ISO 13485, FDA 21 CFR Part 820, MDSAP, and other relevant regulatory frameworks.

• Proven success in implementing and managing quality systems, leading audits, and driving continuous improvement initiatives.

• Hands-on experience with quality risk management tools such as FMEA and root cause analysis techniques.

• Familiarity with quality management software, document control systems, and data analysis platforms.

• Experience supporting the lifecycle of electronic medical devices, including remote troubleshooting, calibration, and field service support is a plus.

• Exceptional leadership, organizational, and interpersonal skills, with the ability to influence at all levels.

• Strong verbal and written communication skills for both technical and non-technical audiences.

• Ability to travel as needed to support field operations, audits, and customer interactions.

• Capable of lifting up to 50 pounds as needed for operational or support purposes.