Associate Director of Quality
This position will report directly to the VP of Global Operations as you get to lead a team of quality professionals that drive key processes to include Quality Plan Creation, Training, Product Quality Review and assurance, Compliance Analysis, Validation protocols, CAPA Management, Non-Conformance Review & Approval and Supplier Evaluation, Selection and Management.
REQUIREMENTS:
- Global and Electromechanical Device Experience
- Lead and manage the quality team to achieve quality goals
- Manage team performance, including disciplinary matters, hiring, career development, and communication
- Develop a departmental strategy to meet customer expectations and improve global quality metrics
- Direct the collection and analysis of quality data for long-term quality strategy
- Lead production process analyses and recommend quality improvements
- Develop and implement program quality plans and procedures
- Promote a culture of process and product quality improvements
- Foster safety-first mentality and improve process efficiency and cost reduction
- Build strong relationships with internal and external stakeholders
- Establish and maintain supplier quality standards and inspection processes
- Collaborate with supply chain to improve purchase part quality
- Monitor critical suppliers through audit programs
- Facilitate cooperation with operations, engineering, and sales to enhance purchase part quality
- Communicate effectively with customers
- Prepare reports on product returns, root causes, corrective actions, and recommendations
- Apply problem-solving tools like lean manufacturing and six sigma
QUALIFICATIONS:
- Minimum of 10 years of engineering and/or Quality experience, preferably in a Med Device-related field, Minimum of 5 years of management
- Excellent personal skills in leadership, coaching, and both written and verbal communication.
- Proven success in leading diverse groups of engineers, managers, and technicians.
- In depth understanding and experience with Quality Systems, including ISO, MDD, and FDA requirements.
- General knowledge of pressure vessel codes.
- Experienced understanding of business software use, CAD systems, and Quality & Design Control systems.
- Thorough knowledge of quality standards, engineering design principles, and process flow evaluation and improvements.
