Quality Manager - Fixed Term Contract

About Convatec

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com

Pioneering trusted medical solutions to improve the lives we touch: Convatec is a global medical products and technologies company, focused on solutions for the management of chronic conditions, with leading positions in Advanced Wound Care, Ostomy Care, Continence Care, and Infusion Care. With more than 10,000 colleagues, we provide our products and services in around 90 countries, united by a promise to be forever caring. Our solutions provide a range of benefits, from infection prevention and protection of at-risk skin, to improved patient outcomes and reduced care costs. Convatec’s revenues in 2024 were over $2 billion. The company is a constituent of the FTSE 100 Index (LSE:CTEC). To learn more please visit http://www.convatecgroup.com

This is a Fixed Term Contract opportunity expected to last approximately 1 year with the ability to be extended.

Position Overview:

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 all product categories.
• 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.

Authority (if applicable):

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

Skills & Experience:

• Seven (7) to ten (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 minimal supervision 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.

Dimensions:

Team

Quality Systems Leads and applicable personnel.

Principal Contacts & Purpose of Contact:

• Internal: Directors, Managers, Engineers, and Supervisors (all departments)
• External: Directors, Managers, Specialists, Engineers, Supervisors and (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/Spanish Advanced Required

• Writing/Reading: Yes English/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.

Ready to join us?

At Convatec, we’re pioneering trusted medical solutions to improve the lives we touch. If you’re ready to make a real impact, apply today and help us bring our Forever Caring promise to life.

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Equal opportunities

Convatec provides equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, gender identity, military or veteran status, genetic predisposing characteristics or any other basis prohibited by law.

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