Senior Director, Quality Engineering

About the role

Edwards is hiring a leader in Quality Engineering who will be responsible for new product introduction, lifecycle management, and continuous improvement of products and processes in a fast-paced manufacturing environment. The role works cross-functionally with manufacturing operations and sales teams and contributes to the delivery of products for patients with cardiovascular disease.

Key responsibilities

• Plan, prioritize and direct strategic program activities, including product, process and quality projects, using engineering methods such as Six Sigma and LEAN in line with compliance standards
• Lead risk identification, mitigation strategies, alternative solutions and issue resolution with cross-functional groups
• Collaborate with leadership on operational strategy and help deliver business objectives
• Provide technical guidance on quality engineering activities across complex product lines and systems, including root cause analysis, complaint product evaluation, corrective actions and product/process change approvals
• Optimize quality engineering processes and define and implement core competencies based on business needs
• Develop talent development and succession planning aligned with the quality organization's growth strategy
• Align with network and COE teams on standardized programs and processes
• Support audits with resources, technical and procedural expertise, presentations and issue resolution

Required profile

• Bachelor's degree in a related field with at least 10 years of experience in engineering and leadership positions in the medical device industry
• Experience in Quality Engineering, Quality Management and/or Regulatory Compliance within the medical device industry
• Demonstrated track record managing technical and/or engineering disciplines
• Proven interaction with regulators and Notified Bodies
• Ability to influence teams in a global environment

Required skills

• Preferred: project management leadership, Microsoft Office Suite and related systems
• Expertise in design of experiments, process capability studies, FMEA, statistical process control, industrial statistics and Lean Manufacturing
• Expert knowledge of domestic and international regulatory requirements
• Ability to direct teams, coach employees and handle hire/fire decisions in partnership with HR
• Ability to integrate metrics that show the value of quality engineering to the business