Quality Assurance Senior Analyst
Há 2 dias
We are seeking a Quality Assurance Senior Analyst to join our team in Brazil. The ideal candidate will have experience in managing MedTech GxP Suppliers process, qualification, monitoring, periodic audits, and audits action plan management.
Key Responsibilities:
- Manage the MedTech GxP Suppliers process - Qualification, monitoring, periodic audits, and audits action plan management.
- Collaborate with business partners such as Procurement, Legal, and Marketing to ensure new Supplier qualification on time for new BIDs.
- Represent Brazil in Latam Purchasing Controls COP.
- Lead regulatory requirements gap assessment and implementation in partnership with Regulatory Affairs and other business partners.
- Represent J&J MedTech in appropriate trade associations and external events as required.
- Support MedTech Brazil Internal and External audit programs as Internal Auditor and Brazil point of contact for external audits.
- Support business stakeholders as Commercial Quality point of contact.
- Lead Non-Conformances and CAPA investigation for the processes under responsibility. Escalate issues as appropriate.
- Propose and lead improvement initiatives for the processes under responsibility.
Required Skills and Qualifications:
- Bachelor's degree in any area. Health sciences and Engineering are preferred.
- Advanced English is mandatory. Intermediate Spanish is also required.
- Advanced Office Package knowledge is necessary.
- Solid ANVISA regulation for Medical Device products is required. Knowledge in INMETRO regulation is a plus.
- Minimum 3 years' experience in Quality Assurance is necessary.
- Previous experience in Suppliers management is desired.
- Previous experience in Regulatory Affairs and regulatory processes is a plus.
- Project Management skills are a plus.
Benefits:
- Opportunity to work with a leading global company
- Collaborative and dynamic work environment
- Chance to develop your career in a growing industry
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