Make a meaningful difference to patients around the world. At Edwards Lifesciences facilities around the world, our Manufacturing teams create the tools, technologies, and devices that transform patients’ lives. As part of our sewing, assembly, delivery, and distribution teams, your attention to detail and commitment to continuous improvement will help us turn innovative ideas into reality. Your purpose-driven work will help leave lasting and positive impacts on patient lives.
How you’ll make an impact:
Supervise a team of QS related roles coordinators/associate and oversee the daily activities, including establishing schedules, organizing and overseeing the execution of complex change efforts, ensuring staff is appropriately trained to perform assigned work, and provide guidance and coaching.
Lead in the evaluation of current and new processes, the identification of opportunities and the implementation of solutions to improve the efficiency of processes within and between related functional areas. Identify technical and/or process problems to determine the root cause, propose recommendations and develop improvement strategies to fill the skills/competence gaps.
Act as a liaison between corporate team and people for unresolved issues. Work with global team to have common approach to compliance management and lead improvement initiatives across functional/global boundaries for QS related roles.
Ensure compliance with internal procedures, and implemented change control process continuously meet EW Quality System in compliance with regulatory requirements.
SME for Quality Systems. Provide training to employees across functions to ensure appropriate understanding and deployment of the system.
Provide multi-functional guidance to the user to facilitate the performance of their required training.
Review and analyze performance metrics. Share trend metrics with management
Other incidental duties assigned by Leadership
What you'll need (Required):
Bachelor's Degree in Engineering or related field.
4 years’ experience using a document product life cycle management system.
Previous related experience with full responsibility for all personnel including hire/fire authority and handling all aspects of employee relations in manufacturing, quality and/or product development engineering required.
What else we look for (Preferred):
Proven project management expertise
Experience working in a medical device industry preferred
Proven expertise in both Microsoft Office Suite, Enterprise Resource Planning (ERP) system, preferably JDE.
Excellent written and verbal communication, and interpersonal relationship skills; possessing strong collaboration skills in partnering with cross functional stakeholders in order to achieve objectives, as well as mediating and negotiating the needs of other areas to achieve consensus.
Solid understanding of medical device documentation development activities.
Full understanding of quality procedures while applying acquired expertise to analyze and solve problems without clear precedent.
Demonstrated ability to supervise 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 of employee.
Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills.
Ability to interact professionally with all organizational levels.
Must be able to work with cross-functional teams as well as with colleagues from other departments within assigned area.
Complete understanding and wide application of principles, theories, and concepts in business area.
Ability to develop creative solutions to challenging problems; adept and experienced problem solver who is capable to determine root cause of technical issues and implements effective solutions in a timely manner.
