[Hiring] Quality Manager @Convatec

Role Description

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, and third parties.

Key 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 ensuring 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 meetings (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.

Authority

This role has signatory rights as listed on Quality Management systems records and procedures.

Skills & Experience

• Two (2) years in regulated industries.
• 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).
• 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.

Qualifications

• Bachelor’s degree in industrial engineering, 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.

Dimensions

• Team: Quality applicable personnel.

Principal Contacts & Purpose of Contact

• Internal: Directors, Managers, Engineers, and Supervisors (all departments).
• External: Directors, Managers, Specialists, Engineers, Supervisors (other manufacturing locations). External auditors, Global Complaint Handling Unit, Global CAPA Handling unit (all departments).

Travel Requirements

You will be expected to travel an estimated 30% of the time, mainly to different Convatec plants (depending on business requirements).

Languages

• Speaking: Yes English and Spanish Advanced Required.
• Writing/Reading: Yes English and Spanish Advanced Required.

Working Conditions

• Office Working.
• EH&S requirements are established in local procedures.
• Employee will not be exposed to any chemicals.
• Maintain general awareness of the CVT’s EHS policy and supporting standards.
• Understand EHS risks and applicable legal requirements associated with their job responsibilities and the appropriate controls in place to manage those risks and requirements.
• Carry out job responsibilities with due professional care and in compliance with legal requirements and internal standards without compromising their own safety or that of others.
• Be alert to EHS hazards in the workplace, responding to them as appropriate and communicating them to responsible management as they are identified (e.g., spills).
• Participate in training, awareness, and community initiatives as appropriate.
• Help drive continuous EHS performance improvement by suggesting potential improvements to responsible management.

Special Factors

• Working flexibly.
• Willingness to work weekends, if required.