Senior Supplier Quality Engineer
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Senior Supplier Quality Engineer bij Johnson & Johnson, Galway, 40 uur/week, 12 maanden.
- Locatie
- Galway, IE
- Werkvorm
- op locatie
- Contractvorm
- detachering
- Eerste waarneming
- Opdrachtgever
- Johnson & Johnson
Eisen
- Knowledge of document control systems, preferably ADAPTIV, ETQ and JDE
- Basic knowledge on statistical analysis and problem-solving techniques
- Strong understanding of GMP, QSR, ISO 13485 requirements
- Experienced with validation certification and auditing of suppliers
- Ability to negotiate and mentor other engineers
- Works under minimum supervision and takes self-directed action
- Ability to take actions as needed based on J&J Credo
- Understands six sigma tools, preferably Green Belt certified or higher
- Professional experience of 5+ years in a related industry
- Understands specification drawings and departmental procedures
- Strong knowledge on corrective and preventive action systems (CAPA)
- Basic knowledge of project management tools
- Bachelor’s degree in an engineering discipline
- 5+ years of experience in Quality Assurance working with suppliers
Wensen
- Experience implementing tools
Omschrijving
Participate, support, and lead activities related to external 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. This position has responsibilities on Ethicon and Cardiovascular and Specialty Solution (CSS) Family of Johnson and Johnson companies, including multiple product platforms such as General Surgery Medical Devices, Sutures, ENT, Infection Preventions Electrophysiology, Neurovascular, Esthetic Surgical and non-surgical devices. Roles and Responsibilities: Supports different business units on the company, following up on situations related to supplier quality. Support the incoming inspection group (technician, team lead supervisor, etc.) on the decision-making process and follow up of material nonconformance with suppliers. Responsible to coordinate supplier investigations, related to material non-conformances. Participate in the investigation process and risk analysis of non-conformances caused by suppliers. Works directly with suppliers and external manufacturers to ensure the products and services received meet requirements and/or specifications. Responsible for approving and/or escalating deviations on product specifications or processes from suppliers. Responsible for generating corrective and preventive actions to suppliers, and verification of the effectiveness of such actions for approval and closure. 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 suppliers’ performance in order to certify them or reduce receiving inspection activities. Participate in the analysis of complaints related to suppliers. Interact with other groups (Sourcing, R&D, LCM, Engineering, etc.) for the process of supplier selection. Visit and evaluate suppliers through audits or technical assessments. Develop and implement improvement programs for 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. Supports the qualification, validation and certification of supplier's inspections methods and equipment. Responsible for the generation or updates to Supplier Quality Agreements. Participate with other functional groups and support activities related to changes requested by or to suppliers. Responsible to review, create and approve changes to company procedures, work instructions, forms, inspection reports and other related controlled documentation. Complete all training on time assigned by the quality compliance department. Responsible for follow ups, implementation and closure of company corrective and preventive actions either internal or external. Attend and participate in quality metric reviews. Participate in different projects like Kaizen, PE (GB/BB) and lean. Responsible for communicating business related issues or opportunities to next management level. Responsible for ensuring personal and Company compliance with all International, Federal, State, local and Company regulations, requirements, policies, and procedures. Performs other duties assigned as needed. How to Succeed: Bachelor’s degree in an engineering discipline is required. Professional experience of 5+ years in a related industry are required. 5+ years of experience in Quality Assurance working with suppliers is required. Strong knowledge on corrective and preventive action systems (CAPA). Basic knowledge on statistical analysis and problem-solving techniques. Basic knowledge of project management tools. Experience implementing tools in desired. Strong understanding of GMP, QSR, ISO 13485 requirements. Experienced with validation certification and auditing of suppliers.
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