Β
Key Responsibilities:
Β· Manage and execute quality compliance activities as required by the local regulations.
Β· Responsible for ensuring the renewal and maintenance of the company licenses and authorizations
required for the commercialization and distribution of medical devices and cosmetics within LATAM countries.
Β· Active participation in internal and external audits, both regulatory and certification-related, ensuring compliance with established standards and best practices. Quality Management System
Β· Establish and maintain management process and SOP according to local regulations. Work with different functions to implement established processes. Β· Develop, write, implement, and maintain documented QA procedures.
Β· Monitor and provide support in managing the quality system, reviewing procedures and ensuring that all quality records are up to date from time to time. Input and update proper data in global Convatec Systems. Non-conformance & Complaint Management
Β· Coach the QA Analyst and raise non-conformity based on the input information provided by the distribution warehouse within LATAM countries.
Β· Manage customer complaint handling process, coach the QA Analyst to report complaints into Trackwise system within 24 hours of awareness. Β· Monitor trend of defects raised and escalate to regional QA if any abnormal trend observed.
Β· Coordinate quality related concern raised by distributor and customers with relevant team.
Β· Manage and share customer response letter with distributor and customers and escalate if there is further concern.
Β· Monitor complaints which overdue for closure and follow up with relevant team
Β· Ensure GxP suppliers within LATAM countries are qualified as required in according to Global procedure. Compile and submit all necessary qualification document and certificate to Global supplier Quality team for evaluation and onboarding process.
Β· Overseeing the Distribution quality aspect of the distribution center activities in LATAM. Ensure Quality Agreements and all the onboarding documentations are up to date and uploaded to Trackwise Supplier Module timely.
Β· Manage and oversee all quality aspects relating to distribution chains, include but not limited to quality agreement and quality related certificate.
Β· Assisting the activities related to quality system at the warehouse, ensuring compliance with requirements for storage, transportation, traceability of products, products inspections and products releases. Support trainings and the documentation as needed.
Β· Coordinate the stop ship activities with local distribution centers and Country QA.
Β· Coordinate the re-inspection according to the protocol or procedure issued by the manufacturing site and report back the inspection results timely
Represent Supplier Quality in the Quarterly Review meeting with the respective distribution center and escalate issue to regional Quality if needed for continuous improvement actions.
Β· Audit distribution center and transportation providers within LATAM region at the planned frequency.
Β· Ensure all audit reports are compiled and uploaded into the Trackwise system in accordance to related Global procedure.
Β· Manage complaints investigation with the distribution centers and Supplier Corrective action request (SCAR) resulted from complaints or audit findings. Ensure all SCARs are processed and closed timely.
Β· Investigate with the transporters/ logistic partner if the complaints were related to the transportation from the LATAM Distribution center Post Market Surveillance Management
Β· Execute post-market related activities such as recalls and corrections. Responsible to consolidate the response form, update the customer service tracker, reconciliation of recall quantity, and report to Global Quality on status of recall for LATAM countries. Local Labelling Activities Management
Β· Develop, write, implement, and maintain documented procedures (Work Instruction) for local labeling activities.
Β· Work closely with Regulatory and Sales to implement any new artwork in the case of new tender or business partner. Review and manage local label artwork.
Β· Coordinate with supply chain and local distribution center on implementation of local labelling. CAPA Management
Β· To implement the CAPA Trackwise Module throughout LATAM countries. Raise, coordinate and track all corrective and preventive actions (CAPA) within LATAM countries and ensure closure within agreed timeline. Training Management
Β· Organizing and conducting internal training sessions, educating teams on regulatory standards, best practices and quality procedures.
Β· Establish, update and maintain training matrix which related to operation for LATAM countries.
Β· Create and update Training Curricular in Compliance Wire for LATAM countries.
Skills & Experience:
Β· A minimum of a bachelorβs degree in science, Engineering, or Medical Technology is required
Β· Previuos experience in post-market quality assurance in medical device industry. Regional experience in managing stakeholders across multiple countries is desirable.
Β· Proficiency in English is mandatory.
Β· Experience in Quality Management Systems, such as ISO-13485:2016 requirements.
Β· Familiarity with national and international regulations applicable to the medical devices and cosmetic products (ANVISA, RDCs, ISO, among others).
Β· Executed or managed a field safety action is desirable.
#LI-ML1
#LI-HybridΒ
Β
Β
Beware of scams online or from individuals claiming to represent Convatec
A formal recruitment process is required for all our opportunities prior to any offer of employment. This will include an interview confirmed by an official Convatec email address.
If you receive a suspicious approach over social media, text message, email or phone call about recruitment at Convatec, do not disclose any personal information or pay any fees whatsoever. If youβre unsure, please contact us at careers@Convatec.com.
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.
Notice to Agency and Search Firm Representatives
Convatec is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Convatec employee by a third party agency and/or search firm without a valid written and signed search agreement, will become the sole property of Convatec. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Already a Convatec employee?
If you are an active employee at Convatec, please do not apply here. Go to the Career Worklet on your Workday home page and View "Convatec Internal Career Site - Find Jobs". Thank you!