Director of Quality

SUMMARY:

The Director of Quality Management will be responsible for the Quality Management System (QMS) and communication with certifying and regulatory bodies. The position requires excellent communication skills and the ability to lead employees and customers in the correct and effective use of QMS processes, documentation, and reporting.

PRIMARY RESPONSIBILITIES:

• Act as the Quality Representative for the Quality Management System by overseeing all quality aspects by defining testing standards, and strategies, formalizing processes, utilizing best practices, and establishing metrics.
• Define and maintain the Quality Management System with respect to required standards and regulations.
• Leads internal and external customer audits.
• Implementation of quality monitoring systems and control of component, process, and product quality
• Effective, fact-based risk control in case of incidents
• Implementation and execution of a periodic Management Review
• Participation in management and staff meetings related to Quality Management topics.
• Accept other job duties related to the Quality Management System and product quality.
• Continually strive for 100% Right First Manufacturing

EDUCATION / EXPERIENCE REQUIREMENTS:

• Master’s degree in Electronic Engineering, Material Science, Mechanical Engineering, Physics, or related technical degrees.
• A minimum of 10 years of experience in electronic product or medical device manufacturing is required.
• Minimum of 10 years of experience with ISO 13485 certified Quality Management Systems required.
• Excellent leadership and communication skills (verbal & written), experience in training and mentoring employees.
• Strong team player

ADDITIONAL PREFERRED KNOWLEDGE, SKILLS, ABILITIES:

• Ability to lead teams and influence decisions based on facts and process thinking.
• Ability to build credibility and trust by demonstrating high ethical standards.
• Excellent organizational, interpersonal, and time management skills
• Excellent verbal and written communication skills that are action-oriented and customer service-focused.
• SMT assembly experience or electronic component manufacturing
• Experience with reliability testing and related statistical methods
• Experience with Manufacturing Execution Systems (MES) and related Business Intelligence Reporting (BI)
• Experience with digital Product Lifecycle Management (PLM) Systems
• Characterized by a cooperative leadership style at eye level, inner calm, and great perseverance.
• Regulatory inspection experience preferred.
• Coach and lead a team effectively. 

SUPERVISORY RESPONSIBILITIES:

• Direct supervision and leadership of the Quality Assurance team.

PHYSICAL DEMANDS & WORK ENVIRONMENT:

• Light physical effort for the occasional movement of product or documentation.
• Regularly required to sit, stand, or walk throughout the facility.
• This position requires periods of working at a desk and performing tasks on a computer.
• Significant periods of standing or walking throughout the facility to interface with other team members.
• Use PPE appropriately when in the manufacturing environment.

TRAVEL REQUIREMENTS:

• Must be able to travel internationally and domestically with an estimated travel time of less than 20%.