Director of Quality Assurance

The Director of Quality Assurance Olive Branch plays a crucial role in ensuring the quality, safety, and regulatory compliance of the company. This leadership position is responsible for developing and implementing quality and regulatory strategies, managing compliance with applicable regulations, and fostering a culture of quality throughout the organization.

Key Responsibilities

Quality Management

Oversee the implementation, adherence, and maintenance of companys Quality Management System (QMS) at the Olive Branch facility.

Establish and monitor key quality performance indicators (KPIs) to track and improve product quality.

Oversee the documentation and record-keeping processes to ensure traceability and transparency.

Oversee the training program.

Implement corrective and preventive actions (complaints, CAPAs) as necessary to address product issues.

Regulatory Compliance

Stay updated with relevant medical device regulations and standards (e.g., FDA 21 CFR 820 & 1271, ISO 13485:2016, NABP) and ensure the companys products comply with these requirements.

Coordinate and lead regulatory inspections and audits, ensuring preparedness and compliance.

Team Leadership

Build and lead a high-performing team of quality professionals, providing mentorship, training, and development opportunities.

Ensure tasks and responsibilities are clearly communicated and executed.

Foster a culture of quality, compliance, and accountability throughout the organization.

Communication and Collaboration

Act as the primary point of contact for the facility for regulatory agencies and notified bodies.

Act as the primary point of contact with customers on new program implementation and higher-level quality issues that may arise.

Lead and collaborate with cross-functional teams to align quality efforts with business objectives.

Audit Management

Manage external and internal audits, ensuring compliance with regulatory standards and addressing findings and observations effectively.

Process Improvement

Identify areas for process improvement within the organization, with a focus on enhancing quality, efficiency, and effectiveness.

Budget and Resource Management

Develop and manage the departments budget, ensuring efficient allocation of resources to meet departmental goals.

Requirements

Bachelors degree in a relevant field; advanced degree (e.g., Masters) preferred.

A minimum of 8-10 years of experience in quality in the medical device industry (or related), with 5-7 years in a leadership role.

Strong knowledge of relevant medical device regulations and standards (e.g., FDA 21 CFR 820 & 1271, ISO 13485:2016, NABP).

Excellent leadership, communication, and team-building skills.

Experience with quality management tools and methodologies (e.g., Six Sigma, Lean).

Strong problem-solving and analytical abilities.

Exceptional attention to detail and organizational skills.