Senior Source Quality Engineer

About MedTech

Fueled by innovation at the intersection of biology and technology were 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 Cardiovascular

Fueled by innovation at the intersection of biology and technology were 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 thats 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 are searching for the best talent for SENIOR SOURCE QUALITY ENGINEER to be in Juarez Chih. Horizontes Plant

Purpose: The Senior Supplier Quality Engineer (Sr. SQE) 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 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 the 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 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:

• Provide timely business support for the assigned CSS Supplier Quality Management (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 to minimize/prevent business disruptions.
• 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 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 drives 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.).
• Understand or anticipate the customers needs and adds value by providing specific metric information tailored to the particular business environment.
• Take actions to identify internal customer requirements and translate customer requirements into potential proactive improvements to components or supplier quality systems.
• Proactively pursue clarification to confirm understanding of internal customer needs and requirements.
• Follow up on commitments and keeps customer management and appropriate parties apprised.
• Respond proactively to changing regulatory and business needs.
• Lead component qualification change projects in collaboration with key business partners and the suppliers applicable functional groups.
• Apply appropriate Quality Engineering and 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
• 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.
• For those who supervise or manage a staff responsible for ensuring that subordinates follow all Company guidelines related to Health Safety and Environmental practices and that all resources needed to do so 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
• Performs other duties assigned as needed

Qualifications / Requirements:

• A minimum of a bachelors degree in Engineering an Applied Science or a related technical and quality field is required.
• A minimum of 4 years of experience in Quality Engineering or Quality Assurance including data analysis risk assessment and risk mitigation is required.
• Prior manufacturing plant or technical background is required.
• Working experience in good manufacturing practice regulated environment is preferred (medical device pharmaceutical etc.).
• 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 nonconformance CAPA systems and investigations laboratory controls production and process controls is required.
• Experience with documentation and technical writing skills in a regulated compliance environment is required.
• Component Qualification/Process Validation experience is preferred. New product introduction experience is desired.
• Prior experience with FDA inspections is desirable.
• Broad knowledge of Quality System Regulations and Supplier Quality Management principles are desired.
• Demonstrated ability to identify compliance risks and assess business impact is required.
• Ability to manage complexity and work in a diverse team environment is essential.
• Ability to deal with complex issues using deductive reasoning critical analysis skills and systematic approaches.