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This function is responsible for the management and overseas of the Quality Systems. Responsible for developing, identifying, analyzing, and improving the quality system. This process will follow the ConvaTec Quality Management Systems, as well as applicable regulations and standards (e.g. 21 CFR Part 820, 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.

Key Responsibilities:

• Supervise the Quality systems team and their support to both Ostomy and Wound Care plants.

• Assist and Coach the teams in conducting investigations of Trainings, Document activities, complaints, non-conformities and /or corrective preventive actions.

• Oversea 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, non-conformities, preventive/corrective actions, internal/external audits, stop shipments, HHEs and any other applicable Quality System requirement.

• Oversea 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.

• Oversea 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.

• Manage the Quality Audit Process. Oversee/prepare the schedule and coordination of both internal audits and external audits. Conduct audits and support auditors. Conduct audits according to the program and communicate their results. Report non-conformities found during audits. Prepare and submit audit reports.

• Lead external audits and certification program.

• 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.

Skills & Experience:

· 7 to 10 years in medical devices industry in leading positions.

· 1 year experience in management/principal 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).

· 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 minimalsupervision and proactive attitude.

Qualifications/Education:

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 21 CFR 820.

· Knowledge of root cause analysis tools.

Travel Requirements:

You will be expected to travel an estimated 5% -10% of the time, mainly to different Convatec plants

(depending on business requirements).

Languages:

· Speaking: Yes English/Spanish Advanced Required

· Writing/Reading: Yes English/Spanish Advanced Required

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