Analista de Qualidade e Conformidade Sr

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities, and forward progress. That’s why for more than 135 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body, and environment within reach of everyone, everywhere. Every day, our more than 140,000 employees across the world are blending heart, science, and ingenuity to profoundly change the trajectory of health for humanity.

Diversity, Equity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years. Regardless of your race, belief, sexual orientation, religion, or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.

When You Join Johnson & Johnson, Your Move Could Mean Our Next Breakthrough.

At Johnson & Johnson MedTech, we unleash diverse healthcare expertise, purposeful technology, and a passion for people to transform the future of medical intervention and empower everyone to live their best life possible. For more than a century, we have driven breakthrough scientific innovation to address unmet needs and reimagine health. In surgery, orthopedics, vision, and interventional solutions, we continue to help save lives and create a future where healthcare solutions are smarter, less invasive, and more personalized.

**We are searching for the best talent for ANALISTA DE QUALIDADE E CONFORMIDADE SR to be in Sao Paulo.**

**Purpose**:This position is responsible for Brazil MedTech Commercial Quality processes governance and improvement. This may include but is not limited to leading local processes execution according to J&J standards and procedures and keep audit readiness culture for internal and external audits, announced or unannounced.

Additionally, this position is responsible for leading and supporting continuous improvement initiatives in collaboration with J&J MedTech local and regional Commercial, Quality and Global stakeholders to ensure Brazil business sustainability and growth.

**You will be responsible for**:

- Manage MedTech GxP Suppliers process - Qualification, monitoring, periodic audits, and audits action plan management. Routine support to Suppliers, and risks / potential risks are also part of this position´s responsibilities.
- 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 new regulatory requirements gap assessment and implementation in partnership with Regulatory Affairs and other business partners.
- Represent J&J MedTech in the 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.
- Collaborate with the overall Brazil and Latam Commercial Quality community as part of One Team.

**Qualifications**:

- Bachelor’s degree in any area. Health sciences and Engineering are preferred.
- Advanced English and mínimally intermediate Spanish are mandatory.
- Advanced Office Package knowledge is required.
- Solid ANVISA regulation for Medical Device products is required. Knowledge in INMETRO regulation will be a plus.
- Minimum 3 years’ experience in Quality Assurance is required.
- Previous experience in Suppliers management is desired.
- Previous experience in Regulatory Affairs and regulatory processes will be a plus.
- Project Management skills will be a plus.