Senior/Supervisor, Quality Systems

Job Description Summary

Supervise a team of QS related roles coordinators and/or associate specialists and ensure appropriate and necessary documentation is in place to meet EW Quality System in compliance with regulatory requirements.

Job Description

Key Responsibilities:

1. 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.
2. 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.
3. 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.
4. Ensure compliance with internal procedures, and implemented change control process continuously meet EW Quality System in compliance with regulatory requirements.
5. SME for Quality Systems. Provide training to employees across functions to ensure appropriate understanding and deployment of the system. Provide multifunctional guidance to the user to facilitate the performance of their required training.
6. Review and analyze performance metrics. Share trend metrics with management.
7. Other incidental duties assigned by Leadership.

Education and Experience:

1. Bachelor's Degree in Engineering or related field.
2. 4 years' experience using a document product life cycle management system.
3. Proven expertise in both Microsoft Office Suite and Enterprise Resource Planning (ERP) system, preferably JDE.
4. Excellent written and verbal communication.
5. Solid understanding of medical device documentation development activities.
6. Full understanding of quality procedures while applying acquired expertise to analyze and solve problems without clear precedent.
7. 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 management.
8. Strong documentation, communication and interpersonal relationship skills including negotiating and relationship management skills.
9. Must be able to work with cross-functional teams as well as with colleagues from other departments within assigned area.