Quality Manager - Fix term Contract

Convatec•Greensboro, NC

4d•Hybrid

About The Position

This is a fixed term contract opportunity that is expected to last approximately one year with the eligibility for extension. This function is responsible for the management and oversight of the Quality Management System. Responsible for developing, identifying, analyzing, and improving the quality management system. This process will follow the Convatec Quality Management Systems, Unomedical Quality System, and all applicable regulations and standards (e.g. Quality Management System Regulation - QMSR, ISO13485, Japan MO-169, Brazil ANVISA). The position requires empowerment and proactivity, time management skills, organization, and attention to detail. The role will have interaction and/or communication, when applicable, with employees, customers, suppliers, third parties.

Requirements

Two (2) years in regulated industries
Experience with QMS regulated software.
Knowledge of change control principles, quality systems, training, standards, and regulations of Medical Device Quality systems.
Demonstrated proficiency in complaints, non-conformance and CAPA management.
Skill on root cause, continuous improvement, and statistical tools.
Strong motivation to achieve good results is essential. Self-directed leadership, requiring minimal supervision and proactive attitude.
Bachelor’s degree in industrial engineer, business administration (desirable) or any other related grade.
Knowledge of the Quality Assurance standard for medical devices like ISO13485 and QMSR.
Knowledge of root cause analysis tools.
Speaking: Yes English and Spanish Advanced Required
Writing/Reading: Yes English and Spanish Advanced Required

Nice To Haves

1 year experience in management/principal/Sr. Engineering positions (preferred).
Experience in leading front or back rooms during external regulatory body Audits.
Experience leading external audits in sister plants (preferable).
Experience with submitting Local Registrations (preferable).
Experience leading investigations of Audit finding (preferable).
Experience in execution training programs (preferable).

Responsibilities

Supervise the Quality team and their support to all relevant product categories.
Assist and Coach the teams in conducting investigations of Trainings, Document activities, complaints, nonconformities and /or corrective preventive actions.
Oversee the Complaint system, assuring corresponding evaluations and/or investigations are completed in a timely manner, trends are analyzed, and applicable actions are executed (e.g. CAPAs, SS, HHE).
Report progress of investigations for complaints, nonconformities, preventive/corrective actions, internal/external audits, stop shipments, HHEs and any other applicable Quality System requirement.
Oversee the CAPA system, assuring corresponding investigations, corrections, containment, and corrective/preventive actions are taken, as well as insuring that their effectiveness is measured; this while also maintaining a system that complies with QMS requirements.
Oversee the Training and Document Management system, assuring corresponding activities, trainings, evaluations and/or investigations are completed in a timely manner, trends are analyzed, and applicable actions are executed.
Execute/report/Analyze trend analysis related to the quality management system.
Participate in local and/or corporate meetings representing the site Quality System and communicating any action/activities that are needed.
Oversee/prepare corresponding reports and/or meeting (e.g. trend analysis, management reviews) to assure the Quality System is robust and complies with requirements, and, if applicable raise corresponding action to keep in compliance.
Lead external audits and certification program, if needed.
Support and participate in company projects.
Identify, develop, and implement continuous improvement projects for products and processes.
Carry out, together with your team and if required, CAPA (Corrective and Preventive Actions).
Follow and enforce the corresponding policies and procedures, implementing solutions aligned to the needs of the business and its products.