The Senior Director of Quality Engineering will assume a strong, pro-active leadership role within the company to manage and advance quality engineering systems to improve and sustain compliance processes by partnering with peers, customers and functional department leaders.
- Oversee, improve and advance Quality Engineering functions and procedures including process, facility and equipment validation, supplier and materials management, manufacturing engineering controls, increase depth and understanding of engineering change control and implementation of system improvements
- Promote the recognition of quality engineering programs within the company to create a shared continuous improvement mindset across functional departments and reinforce basic continuous improvement principles.
- Lead employee development, communication and training programs in connection with the company's strategic goals, quality objectives, and operational systems.
• Bachelor's Degree in Engineering, Biology, Chemistry, or related field; or, equivalent combination of education and experience to perform at this level.
• Minimum 15 years of experience in quality engineering and /or quality systems
• Medical Device industry experience, preferably IVD
• Expert knowledge of US FDA and ISO requirements
• Five years of Supervisory or Department Lead experience in managing both processes and resources
• Strong computer skills
• Exceptionally strong team player with excellent interpersonal and communication skills, and experience working with end-users in a mentoring capacity
• Extremely detail-oriented with strong organizational skills and high quality standards
• Excellent written and verbal communication skills
• Master's Degree
• Experience working with a molecular diagnostic company
• Experience in a Class III medical device environment
• Experience in Operations, Manufacturing, and/or R&D