Senior Director of Quality Engineering

hace 1 mes

Ciudad de México, Ciudad de México Edwards Lifesciences A tiempo completo
Join Our Team as a Senior Director of Quality Engineering

Imagine how your expertise can shape the development of groundbreaking technologies to ensure the highest standards of integrity and safety. Our Quality teams collaborate with various teams to influence decision-making for a product's entire lifecycle. Your work will involve optimizing product development to impact patients around the world with pioneering technology.

Key Responsibilities:
  • Direct a team with responsibilities for quality engineering activities, including process and test methods validations, product transfer, process improvements, non-conformance investigation, corrective action, product disposition, complaint analysis, and risk management.
  • Plan, prioritize, and direct strategic program activities, including product, process, and quality projects using engineering methods to align with applicable compliance standards.
  • Collaborate with leadership to develop operational strategy and partner with cross-functional groups/resources to achieve tactical execution of business objectives.
  • Provide technical guidance to cross-functional teams on quality engineering activities that integrate into multiple product lines and/or systems with significant complexity.
  • Identify and lead efforts to optimize quality engineering processes and define and implement core competencies.
  • Develop robust talent development and succession planning in alignment with functional growth strategies across the quality organization.
  • Collaborate and align with network and COE teams in driving standardized programs and/or processes.
  • Provide quality engagement to audits, including resources support, technical and procedural expertise, presentation of information, and effective resolution of issues.
Requirements:
  • Bachelor's Degree in a related field with experience in engineering and skill levels exceeding the requirements of the Director.
  • Experience in quality engineering, quality management, and regulatory compliance within the medical device industry.
Preferred Qualifications:
  • Proven successful project management leadership skills.
  • Proven expertise in both Microsoft Office Suite and related systems.
  • Excellent problem-solving, organizational, analytical, and critical thinking skills, including high discretion/judgment in decision making.
  • Excellent documentation and communication skills and interpersonal relationship skills, including negotiating and relationship management skills with the ability to drive achievement of objectives.
  • Expert understanding of engineering procedures while looking beyond existing methodologies and own discipline to define and resolve complex problems.
  • Expert understanding of related aspects of quality engineering processes and/or systems.
  • Expert knowledge of domestic and international regulatory requirements, including FDA, GMPs, and ISO/EN standards.
  • Expert knowledge of design of experiments, process capability studies, failure mode and effects analysis, statistical process control, industrial statistical methods, and Lean Manufacturing.
  • Knowledge of financial acumen as it relates to the business as well as quality engineering.
  • Demonstrated ability to direct teams and provide coaching and feedback, including responsibility for all employee actions, including hire/fire authority, and partnering with HR on all aspects of employee relations.
  • Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of quality engineering to the business.
  • Serve as a core partner to senior leaders in Business Units, Functional Groups, Regions, and IT.
  • Strict attention to detail.
  • Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization.
  • Ability to work and excel within a fast-paced, dynamic, and constantly changing work environment.
  • Interact with senior management and others concerning matters of significance to the company.
  • Conduct business and technical briefings for senior and top management and for external representatives.
  • Regularly interact with executives and/or major customers; interactions frequently involve special skills, such as negotiating with customers or management or attempting to influence senior-level leaders regarding matters of significance to the organization.
  • Dedicated to quality client service and pro-active and responsive to client needs.
  • Develop peer, cross-functional, and cross-business relationships to maximize best practice sharing and team effectiveness.
  • Provide leadership and direction to large cross-functional teams to successfully implement global enterprise systems and related solutions.
  • Develop relationships and leverage them to influence change.
  • Support and solicit input from team members at all levels within the organization.
  • Adhere to all company rules and requirements, including pandemic protocols, Environmental Health & Safety rules, and take adequate control measures in preventing injuries to themselves and others as well as to the protection of the environment and prevention of pollution under their span of influence/control.

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