Provide strategic direction and leadership for the QA and QC teams, ensuring compliance with regulatory requirements and industry standards including, but not limited to 21 CFR 820 and 211, ISO 13485, MDSAP, and ISO 14971.
Analyze data and metrics to identify areas for improvement and implement corrective/preventive actions.
Drive continuous improvement initiatives to enhance product quality, reduce defects, and improve manufacturing processes.
Work closely with cross-functional teams, including R&D, Manufacturing, and Regulatory Affairs, to ensure quality standards are met throughout the product lifecycle.
Ensure timely completion of quality-related projects and activities, supporting overall project timelines and goals.
Maintain a state of audit readiness, ensuring all quality systems and processes are compliant with regulatory requirements and prepared for internal and external audits.
Provide thought leadership and guidance to all site teams, fostering a culture of quality and continuous improvement.
Oversee the development and maintenance of quality documentation, including SOPs, work instructions, and quality records.
Collaborate with Corporate Training department to develop and implement training programs to ensure all employees are knowledgeable about quality standards and procedures.
Identify and mitigate quality risks, ensuring proactive measures are in place to address potential issues.

Bachelor's degree in relevant discipline
10+ years of experience in the medical device or biologics industry
7+ years of leadership experience
Excellent verbal and written communication
Microsoft Office Suite, intermediate Excel
Statistical techniques
Problem-solving methodologies
Technical writing
Quality Management System (QMS) software
Up to 20% of travel may be required
Move or lift objects up to 25 pounds
Frequent (>75%) stationary position (standing or sitting) while utilizing digital displays
Frequent (>75%) fine manipulation using hands and fingers (typing, opening, writing, clicking, paper sorting, etc.)

Quality Director

Key skills