Align is the industry leader and innovator in medical devices which focuses on revolutionizing the dental and orthodontic industry. Align, the makers of Invisalign ® is looking for aManager, Product Quality Engineer. This exciting new role would be part of a culture that is helping to improve lives every day through digital dentistry.Thewill lead our efforts to ensure the highest standards of product quality, emphasizing performance and customer satisfaction over mere regulatory compliance. This role requires a proactive approach to enhancing product excellence, incorporating innovative quality improvement methods, and fostering a culture of continuous improvement within the product development lifecycle.
In this role, you will…
- Quality Leadership:Develop and implement quality assurance strategies that align with business objectives and operational requirements. Manage the product quality team to ensure that product standards are met and exceeded.
- Process Improvement:Continuously assess and refine quality processes, employing modern quality management tools and techniques to enhance product reliability and performance.
- Cross-Functional Collaboration:Work closely with the product development, manufacturing, and supply chain teams to integrate quality control measures throughout the product lifecycle.
- Quality Metrics:Define and monitor key performance indicators (KPIs) for product quality. Regularly report on quality outcomes, trends, and improvement opportunities to senior management.
- Customer Focus:Ensure that customer feedback is integral to quality improvement initiatives. Lead root cause analysis and corrective actions to resolve product issues efficiently.
- Training and Development:Cultivate a high-performing quality team through targeted training, mentoring, and development activities. Promote a strong quality culture across the organization.
- Regulatory Awareness:Although not reporting to Regulatory Affairs, maintain an informed understanding of relevant industry regulations to ensure that quality practices align with current standards.
Typically:
- Bachelor’s degree in Quality Management, Business Administration, Engineering, or a related field. A Master’s degree is preferred.
- Minimum of 7 years’ experience in quality management, with at least 3 years in a leadership role within a product-focused industry.
- Strong analytical skills and proficiency in quality improvement tools and methodologies (e.g., Six Sigma, Lean Manufacturing).
- Excellent communication and interpersonal skills, with the ability to lead cross-functional teams and interact effectively with all levels of the organization.
- Demonstrated ability to drive change and implement innovative quality initiatives in a complex business environment.
- Proficiency in English.
