Job Information
J&J Family of Companies Supplier Quality Engineer in Grecia, Costa Rica
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com (https://www.jnj.com.) .
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
Job Function:
Quality
Job Sub Function:
Supplier Quality
Job Category:
Professional
All Job Posting Locations:
Grecia, Costa Rica
Job Description:
About MedTech
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
About Cardiovascular
Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that’s reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
We are searching for the best talent for Supplier Quality Engineer.
Purpose:
Supplier Quality Engineer provides overall quality assurance leadership in the management of Direct, Indirect Suppliers and/or External Manufacturers engaged in the production of Johnson and Johnson products. The SQE will be responsible for external suppliers of direct and indirect materials, finished goods and services for the CSS franchise. He/she leads the deployment of Supplier Quality Management (SQM) strategies and associated standards, policies, procedures, programs, systems, processes, and initiatives for suppliers of the CSS supply chain.
This individual will leverage talents and coordinate teams (SQEs and others), collaborate with Strategic Sourcing/Procurement, R&D, Engineering/Technical Operations, Quality, Operations, business partners/stakeholders, and external suppliers to implement solutions and improve suppliers’ quality and overall service and performance. In this role, the individual supports the execution of plans/strategies, and implementation of systems, processes, and procedures to ensure robust supplier/purchasing controls with regards to the determination, selection, qualification, monitoring, and disengagement of suppliers. She/he proactively identifies, develops, and leads the investigation and resolution of supplier- related challenges, and implements appropriate Quality Engineering methodologies, statistical techniques, process capability analyses/improvements, DOE/process optimization, and other technical or Process Excellence (PEx) tools in support of supplier-related changes, risk management, product/process transfers, innovations, and continuous process enhancements to improve supplier reliability, minimize risks, and ensure sustainable sources of material supply capable of meeting or exceeding Quality, Compliance, and Business requirements.
You will be responsible for :
In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
Provide timelybusiness supportfor the assignedCSSSupplierQualityManagement(SQM) function globally.
Lead, develop, and implement supplier/purchasing controls and associated activities including Approved Supplier List management.
Participate in and/or support the identification, selection, qualification, monitoring, and disengagement of suppliers for Supplier Quality Management. May lead this process under the guidance of Supplier Quality Manager and/or management representative.
Collaborate with suppliers and business partners to ensure robust materials, products, processes, and systems.
Partner with Procurement, R&D, Engineering/Technical Operations, Quality, Operations, and Suppliers in the timely investigation, resolution/prevention of supplier-related issues.
Monitor and analyze supplier performance metrics, identify areas of opportunity, communicate supplier risks, and drive the resolution of supplier quality issues and risk control processes.
Implement supplier change management process including change notification, dissemination of information, impact assessment, approval of changes, and supports material/supplier qualifications.
Own, drive, and lead the assigned Supplier Quality related projects, activities, initiatives with limited supervision.
Utilize Project Management methodologies to plan, organize, connect, shape, lead, and deliver results for SQM projects.
Utilize analytical and problem-solving skills to develop and optimize supplier performance by working in conjunction with the Worldwide Supplier Quality Management Team.
Analyze quality data and identify trends impacting risk benefits requirements of product and quality systems for external suppliers. Actively participates in discussions to drive resolution.
Collaborate with operations and franchise operations development on process/product improvement projects.
Prepare Supplier Quality Agreements and have discussion with supplier while consulting Supplier Quality Manager and/or management representative.
Develop/execute Quality Risk Management process for supplier-related matters with partnerships of subject-matter experts
Own and lead the Supplier Quality Relationship Management (SQRM) process for the assigned suppliers (e.g., Lead periodic SQRM meetings including supplier quality performance reviews, supplier investigation follow- ups, investigation responsiveness/cycle time, targeted improvement plans (TIP), closed loop corrective actions, NC reductions, supplier quality metrics, etc.).
Respond proactively to changing regulatory and business needs.
Lead component qualification changes projects in collaboration with key business partners and the supplier’s applicable functional groups.
Comply with all applicable quality management system, environmental, safety and occupational health policies. (For example, ISO 13485, ISO14001 & OSHAS18001).
Responsible for communicating business related issues or opportunities to next management level.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
Performs other duties assigned as needed
Qualifications / Requirements:
Experience and education
A minimum of a Bachelor’s Degree in Engineering, an Applied Science or a related technical and quality field is required.
0 to 2 years of experience in Supplier Quality or Quality, including data analysis, risk assessment and risk mitigation is required.
Experience in the medical device and/or pharmaceutical industry is preferred
Demonstrated knowledge of manufacturing principles and practices, and procedures.
Direct experience in plant and/or supplier GMP auditing is preferred.
Broad experience with quality systems, including but not limited to validation, non-conformance, CAPA systems and investigations.
Broad knowledge of Quality System Regulations and Supplier Quality Management principles are desired.
Required knowledge, skills, abilities, certifications/licenses and affiliations
Working knowledge of regulatory compliance requirements (i.e. Quality System Regulations (QSRs), Medical Device Directive (MDD), ISO 9001, ISO 13485, ISO 14971 or other international standards) required.
Working knowledge of Quality issue investigation, Non-Conformance Reports (NCRs), Corrective and Preventative Actions (CAPAs) preferred.
ASQ Improvement Associate / Quality Auditor certifications, desirable.
Strong analytical skills, metrics development and ability to identify trends are desirable.
Knowledge of specific business practices and software applications skills (Word®, Excel®, PowerPoint®, Minitab®, Visio®, Microsoft Project®) is preferred
Ability to communicate effectively in English.
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Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Compliance Management, Controls Compliance, Cross-Functional Collaboration, Execution Focus, ISO 9001, Issue Escalation, Performance Monitoring, Persistence and Tenacity, Quality Auditing, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Technologically Savvy, Vendor Selection