At Convatec, we’re transforming our business for the better. Better products. Better ways of working. And better ways of delivering for our customers and each other. We’re aiming for nothing short of excellence. Join us on our journey to #ForeverCaring as our Site Quality Director and you’ll do the same.
The Quality function is responsible for the management and overseeing of the Quality Management Systems and operations from the Haina Plant. It is responsible for developing, identifying, analyzing, and improving the quality management system, operations and KPI as well as ensuring that the processes are in line with the ConvaTec Quality Management Systems. This includes applicable regulations and standards (e.g. 21 CFR Part 820, ISO13485, Japan MO-169, Brazil ANVISA)
This key role requires empowerment and proactivity, time management skills, organization, and attention to detail. The successful candidate will have interaction and/or communication across a wide variety of stakeholders including employees, customers, suppliers and third parties.
Key responsibilities include:
Lead the department of Quality at the ConvaTec Local plant.
Sponsor individual, local and potentially global development opportunities for Global Quality Management personnel, through the projection of the Quality Organization in a way that requires continuous advancement and skills and techniques
Assist and Coach the teams in conducting Improvements Events; Audits; Trainings; Document activities, Complaints, non-conformities and /or corrective preventive actions; among others, assuring that the Quality Management system of the plant is suitable and complies to requirements.
Serve as a guide and advisor to other team members, and collaborators, in other to guide the decision towards compliance and business benefit.
Develop, communicate and execute strategies and vision that are aligned with the business, corporation's objectives, and the overall direction of Global Quality Management.
Anticipate, evaluate and manage compliance and risks of current and future processes that have both direct and undirect impact on business success.
Develop and manage the local quality budget, meeting annual budget goals.
Drive the implementation of local and global efforts, including processes, resources and strategies.
Proactively ensure, supported by local and global teams, that the quality inspection system is always ready to audit the processes and work of everyone in the locality.
Create and communicate a commitment to quality and continuous improvement, maintaining a focus on achieving customer satisfaction throughout the product life cycle.
Create systems, processes and opportunities that motivate the leveling of Quality resources through the Regional Quality Management network and the Global Quality Management network.
Work closely with global support groups and individual plants, as appropriate, in leading plant operations activities and improvement efforts.
Partner with global support groups to execute and facilitate corporate initiatives to pursue and achieve established objectives.
Work closely with the Plant Quality Management Leaders to ensure a systemic and risk-based approach to our Quality Management System.
Representative of Senior Management, with responsibility and authority, but not limited, to:
Ensuring that the processes necessary for the management of the Quality System are documented.
Reporting to senior management on the effectiveness of the Quality Management System and any need for improvement.
Ensuring knowledge of applicable regulatory requirements and Quality Management System requirements throughout the organization.
Ensuring that the quality policy is understood, implemented and maintained throughout the organization.
Ensuring that there are competent and trained resources to be assigned to quality system management activities.
Ensure progress of investigations for complaints, non-conformities, preventive/corrective actions, internal/external audits, stop shipments, HHEs and any other applicable Quality System requirement are maintained and communicated accordingly.
Participate in local and/or corporate meetings representing the site Quality and communicating any action/activities that are needed.
Oversee/prepare corresponding reports and/or meeting, as needed, to assure the Quality System is robust and complies with requirements, and, if applicable raise corresponding action to keep in compliance.
Oversee, support, and or lead external and or internal audits and certification program.
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.
Your key responsibilities will include the following :
Leading the Quality department in our Haina plant
Sponsoring individual, local and potentially global development opportunities for Global Quality Management personnel, through the projection of the Quality Organization in a way that requires continuous advancement and skills and techniques
Assisting and coaching the teams in conducting Improvements Events; Audits; Trainings; Document activities, Complaints, non-conformities and /or corrective preventive actions; among others, assuring that the Quality Management system of the plant is suitable and complies to requirements.
Serving as a guide and advisor to other team members, and collaborators, to guide the decision making towards compliance and business benefit.
Developing, communicating and executing strategies and vision aligned with the business, corporation's objectives, and the overall direction of Global Quality Management.
Anticipating, evaluating and managing compliance and risks of current and future processes that have both direct and undirect impact on business success.
Developing and managing the local quality budget, meeting annual budget goals.
Driving the implementation of local and global efforts, including processes, resources and strategies.
Proactively ensuring that the quality inspection system is always ready to audit the processes and work of everyone in the locality, supported by both our local and global teams.
Creating and communicating a commitment to quality and continuous improvement, maintaining a focus on achieving customer satisfaction throughout the product life cycle.
Creating systems, processes and opportunities that motivate the leveling of Quality resources through the Regional Quality Management network and the Global Quality Management network.
Working closely with global support groups and individual plants, as appropriate, in leading plant operations activities and improvement efforts.
Partnering with global support groups to execute and facilitate corporate initiatives to pursue and achieve established objectives.
Working closely with the Plant Quality Management Leaders to ensure a systemic and risk-based approach to our Quality Management System.
Being a representative of Senior Management, with responsibility and authority, but not limited, to:
Ensuring that the processes necessary for the management of the Quality System are documented.
Reporting to senior management on the effectiveness of the Quality Management System and any need for improvement.
Ensuring knowledge of applicable regulatory requirements and Quality Management System requirements throughout the organization.
Ensuring that the quality policy is understood, implemented and maintained throughout the organization.
Ensuring that there are competent and trained resources to be assigned to quality system management activities.
Ensuring progress of investigations for complaints, non-conformities, preventive/corrective actions, internal/external audits, stop shipments, HHEs and any other applicable Quality System requirement are maintained and communicated accordingly.
Participation in local and/or corporate meetings representing the site Quality and communicating any action/activities that are needed.
Overseeing/preparing corresponding reports and/or meeting, as needed, to assure the Quality System is robust and complies with requirements, and, if applicable raise corresponding action to keep in compliance.
Overseeing, supporting, and or leading external and or internal audits and certification program.
Carrying out, together with your team and if required, CAPA (Corrective and Preventive Actions).
Following and enforcing the corresponding policies and procedures, implementing solutions aligned to the needs of the business and its products.
What we are looking for in you :
Skills & Experience:
At least 10 years' experience in medical devices industry, pharmaceutical, Bio or Chemical, in leading positions.
5 to 7 years' experience in management/principal positions (preferred).
Experience in leading front or back rooms during external regulatory body Audits.
Experience leading investigations of Audit finding (preferable).
Experience in execution training programs (preferable).
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.
Knowledge of the Quality Assurance standard for medical devices like ISO13485 and 21 CFR 820.
Knowledge and/or experience in global quality standards and/or regulations (e.g. applicable standards/regulations from Australian Therapeutic Goods Administration (TGA), Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA), Health Canada, and the U.S. Food and Drug Administration (FDA)., ISO 13485.
Knowledge of root cause analysis tool (e.g. 6M, Ishikawa, 5why) and problem-solving methodologies (e.g. DMAIC, PDCA, 8D)
Qualifications/Education:
Bachelor’s degree in industrial engineer, business administration (desirable) or any other related grade.
Certified Lead Auditor ISO 13485 (preferable).
Certified Lead Auditor EU MDR (preferable).
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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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