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.

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:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

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 Experienced Quality Engineer.

Purpose:

The Experienced Engineer, Quality Engineering provides overall leadership in quality assurance for the management of direct, indirect suppliers and/or external manufacturers involved in the production of Johnson & Johnson products. The Sr. 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 CSS supply chain suppliers. This individual will leverage their talents and coordinate teams (SQEs and others), collaborate with Strategic Sourcing/Purchasing, R&D, Engineering/Technical Operations, Quality, Operations, business partners/stakeholders, and external suppliers to implement solutions and improve supplier quality, service, and overall performance. In this role, the person supports the execution of plans/strategies and the implementation of systems, processes, and procedures to ensure strong supplier/purchasing controls regarding supplier determination, selection, qualification, monitoring, and disengagement. He/She proactively identifies, develops, and leads the investigation and resolution of supplier-related challenges, and implements appropriate Quality Engineering methodologies, statistical techniques, process capability analysis/improvements, process optimization (DOE), and other technical or Process Excellence (PEx) tools to support supplier-related changes, risk management, product/process transfers, innovations, and continuous process improvements to enhance supplier reliability, minimize risks, and ensure sustainable sources of 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 Johnson & Johnson corporate procedures and guidelines, this position:

• Provides timely business support for the assigned CSS Supplier Quality Management (SQM) function globally.
• Leads, develops, and implements supplier/purchasing controls and associated activities, including management of the Approved Supplier List.
• Participates in and/or supports the identification, selection, qualification, monitoring, and disengagement of suppliers for Supplier Quality Management. May lead this process under the guidance of the Supplier Quality Manager and/or management representative.
• Collaborates with suppliers and business partners to ensure robust materials, products, processes, and systems
• Partners with Purchasing, R&D, Engineering/Technical Operations, Quality, Operations, and Suppliers in timely investigation, resolution/prevention of supplier-related issues to minimize/prevent business disruptions.
• Monitors and analyzes supplier performance metrics, identifies areas of opportunity, communicates supplier risks, and leads resolution of quality issues and risk control processes.
• Implements supplier change management processes, including change notification, information dissemination, impact assessment, change approval, and support in material/supplier qualifications.
• Is responsible for, drives, and leads assigned projects, activities, and initiatives related to Supplier Quality with limited supervision.
• Uses Project Management methodologies to plan, organize, connect, structure, lead, and deliver results in SQM projects.
• Analytical and problem-solving skills apply to develop and optimize supplier performance in conjunction with the global Supplier Quality Management team. • Analyzes quality data and identifies trends impacting product risk-benefit requirements and supplier quality systems. Actively participates in discussions to drive resolution.
• Collaborates with franchise operations and operations development on process/product improvement projects.
• Prepares Supplier Quality Agreements and leads discussions with suppliers in consultation with the Supplier Quality Manager and/or management representative.
• Develops/executes Quality Risk Management processes for supplier-related matters in collaboration with subject matter experts.
• Is responsible for and leads the Supplier Quality Relationship Management (SQRM) process for assigned suppliers (e.g., leads periodic SQRM meetings including supplier quality performance reviews, investigation follow-ups, investigation response times, specific improvement plans, closed corrective actions, reduction of non-conformances, supplier quality metrics, etc.).
• Understands or anticipates customer needs and adds value by providing metric-specific information tailored to the particular business environment.
• Takes action to identify internal customer requirements and translates them into potential proactive improvements for supplier components or quality systems.
• Proactively seeks clarification to confirm understanding of internal customer needs and requirements. Follows up on commitments and keeps the customer, management, and relevant parties informed.
• Proactively responds to regulatory changes and business needs.
• Leads component requalification change projects in collaboration with key business partners and applicable supplier functional groups.
• Applies appropriate Quality Engineering and Process Excellence (PEx) tools (e.g., PM/VSM, Kaizen, DMAIC, FMEA/FTA, RCA, MSA, SPC, Cp/Cpk/Cpm/Ppk, Hypothesis Testing, ANOVA/DOE/EVOP, etc.) to support innovations and continuous improvements.
• Complies with all applicable quality, environmental, occupational health and safety management system policies. (e.g., ISO 13485, ISO14001, and OSHAS18001). • Responsible for communicating business-related issues or opportunities to the next level of management.
• For those who supervise or manage personnel, responsible for ensuring their subordinates follow all Company guidelines related to Health, Safety, and Environmental practices, and that all necessary resources are available and in good condition, if applicable.
• Responsible for ensuring personal and Company compliance with all federal, state, local, and Company regulations, policies, and procedures.

Qualifications / Requirements:

Experience and education

• University bachelor’s degree in engineering: Mechanical, Electrical, Industrial or applicable science.
• 2 to 4 years of work experience or demonstrated performance

Required knowledge, skills, abilities, certifications/licenses and affiliations

• Practical knowledge of regulatory requirements is required (e.g., QSRs, MDD, ISO 9001, ISO 13485, ISO 14971, or other international standards).
• Practical experience in quality issue investigation, nonconformance reports (NCRs), and corrective and preventive actions (CAPAs) is preferred.
• ASQ certifications such as Certified Quality Engineer (CQE), Certified Quality Manager (CQM), and/or Certified Supplier Quality Professional (CSQP) are preferred.
• Qualifications as a Quality Auditor or certifications such as ASQ Lead Auditor (CQA) or Biomedical Auditor (CBA) are preferred.
• Training and certification in Flawless Project Execution (FPX) or Project Management Professional (PMP) are preferred.
• Six Sigma certification (Black Belt/Green Belt – CSSBB/CSSGB) or Lean certification from a recognized program, or PE leadership training, is preferred.
• Strong analytical skills, metric development, and trend identification capabilities are desired.
• Knowledge of specific business practices and proficiency in software applications (Word®, Excel®, PowerPoint®, Minitab®, Visio®, Microsoft Project®) is preferred.
• Good business judgment is required. Ability to collaborate with all levels of management in a cross-functional team environment is essential.
• Effective communication skills in English are required.

#LI-Onsite 

 

 

Required Skills:

 

 

Preferred Skills:

Analytical Reasoning, Coaching, Customer Centricity, Data Savvy, Document Management, Financial Competence, Good Automated Manufacturing Practice (GAMP), Lean Supply Chain Management, Process Improvements, Quality Control Testing, Quality Services, Quality Standards, Quality Systems Documentation, Quality Validation, Science, Technology, Engineering, and Math (STEM) Application, Supervision, Supply Planning, Technologically Savvy