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Quality & Compliance Specialist

Quality & Compliance Specialist
Empresa:

Johnson & Johnson


Detalles de la oferta

Quality & Compliance Specialist If you're passionate about your career every single day, we'd love to hear from you!

We invite you to read this Job Description and apply if you are passionate about the position and meet the requirements.

Medical Devices Segment- Johnson Medical
Our Medical Devices business segment produces a broad range of innovative products and solutions used primarily by health care professionals in the fields of orthopaedics, neurological disease, vision care, infection prevention, cardiovascular disease, and aesthetics.

Position Description:
Quality & Compliance Specialist will be responsible for the Supplier & Distributor Audits program supporting the execution of audits in the Southern Custer including the follow up of the corresponding CAPA plan. This role supports the Quality System Audits Inspection Readiness activities for JJRC Audits. Reports directly to the Business Quality Sr. Manager for Southern Cluster.

Insert Key Responsibilities:

1. Support the Supplier & Distributor audits for BQ MD LATAM and support the Cross Sector Supplier/Distributor Audit Program executing the assigned audits.
2. Maintains Audit Readiness processes to ensure the Quality Management System is maintained in a state of readiness to applicable regulations and local Health Authorities requirements.
3. Coordinates cluster preparations for external audits and inspections.
4. Support development of responses to address external audit and inspections results.
5. Responsible for reporting, tracking and timely closure of audit (supplier, distributor & external) applicable corrective and preventive actions.
6. Alert management of quality & compliance issues for proper and timely escalation to Regional and Franchise Management and to Management Review.
7. Performs & reports compliance metrics and drive improvement on those metrics.
8. Perform Field Actions and Change Control meetings including the the preparation of the corresponding monthly metrics.
9. Ensure results of monitoring process are routinely communicated to management through the Region Management Review process.
10. Serves on cross region project teams consistent with company goals and objectives to improve overall compliance & quality system performance to established metrics and requirements.
11. Ensure results of monitoring process are routinely communicated to BQ Cluster Sur management
12. Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings.

Qualifications
Qualifications:
1) Education level required: A Bachelor's degree is required. A degree in science, engineering or related field is preferred.
2) Years of Experience: A minimum of 3 years experience working in a regulated environment is required.
3) Required knowledge: Proficiency in the Microsoft Office suite of products is required.
4) Required skills: Attention to details, Strong written and verbal communication skills, Planning & Organization skills, Management of Complexity, Results Oriented, Ability to proactively identify improvement opportunities, Ability to manage multiple priorities and deliver excellent results, Proactive team player, able to take charge and follow-through, Strong teaming and collaboration skills.
5) Required Experience: Strong regulatory compliance experience is required. Medical Device and Pharmaceutical manufacturing experience is strongly preferred.
6) Language: Advanced English level
7) Certifications: Current Certified Quality Auditor (CQA), Certified Biomedical Auditor (CBA) and/or lead auditor certification is preferred, but not required.
8) Location of the role: Thames - San Isidro. Argentina.

Diversity and inclusion are central elements of the shared culture across the Johnson & Johnson Family of Companies.
Attracting, developing and retaining a workforce that reflects the diversity of our customers and communities is essential to our success.
We are committed to providing a respectful, inclusive and accessible work environment where all employees have the opportunity to achieve their potential.
We are proud to be an equal opportunity employer.

Primary Location
Argentina-Buenos Aires-Capital Federal-Colect.Panam.Oeste 1804-piso 2
Organization
Johnson & Johnson Medical S.A. (7435)
Job Function
Quality Systems
Requisition ID
2083190812


Fuente: Bebee

Requisitos

Quality & Compliance Specialist
Empresa:

Johnson & Johnson


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