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Staff Supplier Quality Engineer
Requisition ID: 5486171127
Johnson & Johnson’s Cardiovascular & Specialty Solutions (CSS) Group within Medical Devices is recruiting for a Staff Supplier Quality Engineer for Sterilmed located in Plymouth, MN. Less than 25% domestic travel is required.
The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Surgical and Non-Surgical Aesthetics, Neurovascular, and Reprocessing. The CSS Group is committed to delivering innovative products, solutions and programs to address unmet customer and patient needs around the world. Our customers and the patients they treat are our first priority and these values are reflected in Our Credo, which guides our daily decisions and actions. Our relentless commitment to Quality and the principles that define us in Our Credo have helped us achieve significant milestones and continues to help us deliver significant growth year after year.
The Staff Supplier Quality Engineer participates, support, and lead activities related to suppliers of raw material, components, finished devices and services for the inspection of incoming materials, implementation of corrective/preventive actions, validations, certifications, qualifications and any project related to quality improvement.
Other responsibilities include:
• Work directly with suppliers to ensure that the product or service received meets requirements and specifications. Responsible for generating quality standards and maintaining current standards. Develop and implement improvement programs for suppliers. Attend and participate in quality metric reviews.
• Responsible for generating corrective and preventive actions to suppliers, and verification of the effectiveness of such actions for approval and closure. Responsible for follow ups, implementation and closure of corrective and preventive actions either internal or external. Collect and distribute supplier performance data.
• Support suppliers on the implementation of improvement plans (example SPC, Gage R&R, etc) Support and lead initiatives to improve supplier’s performance in order to certify them or reduce receiving inspection activities. Participate in the analysis of complaints related to suppliers.
• Participate in different projects like Kaizen, PE (GB/BB) and lean. Interact with other groups for the process of supplier selection. Support other groups of the company on any quality issues related to suppliers. Support the Quality Audit group providing quality metrics and supplier performance data. Participate and support the introduction of new products in relation to new components or finished devices provided by suppliers.
• Responsible for the generation or updates to Supplier Quality Agreements. Participate and support activities related to changes requested by suppliers. Participate in the investigation process and risk analysis of non-conformances caused by suppliers. Complete all training on time assigned by the quality compliance department. Responsible for approving and/or escalating deviations on product specifications or processes from suppliers.
• Responsible to review, create and approve changes to procedures, work instructions, forms, specifications, inspection reports and other related controlled documentation. Support receiving inspection group to take actions when a nonconformance is received.
• Visit and evaluate suppliers thru audits or technical assessments. Responsible for communicating business related issues or opportunities to next management level.
• A Bachelor’s degree in a Science, Technical or Engineering related field, is required.
• Professional experience of 5 years in a related industry is required.
• A minimum of 5 years of experience in Quality Assurance working with suppliers is required.
• Understands corrective and preventive action systems (CAPA), statistical analysis techniques, GMP, QSR, ISO 13485 requirements, validation, certification and auditing of suppliers is required.
• Understands basic project management tools is required.
• Understands specification drawings and departmental procedures. Understands Six Sigma tools, preferably Green Belt certified or higher, is required.
• Works under minimum supervision and takes self-directed action is required.
• Ability to develop and implement quality standards, understands business principles is required.
• ASQ certified in Quality Engineering is preferred.
Sterilmed, Inc. (6215)