Johnson & Johnson Careers
Requisition ID: 1805686202W
The Quality Engineer applies intermediate Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, and industry best practices to assignments. Plans and conducts projects and assignments with technical responsibility or strategic input. Receives intermittent, moderately detailed instructions from technical Quality leaders at various levels, in addition to other stakeholders.
For our location in Neuchatel we are looking for a
- Lead and/or support Quality and Supplier Quality change projects.
- Utilize quality engineering principles and problem-solving skills to develop and optimize products/processes. Utilize statistical tools and techniques to establish sampling plans.
- Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements.
- Develop and implement control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
- Develop and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
- Ensure the development of a comprehensive risk management plan for the product and process.
- Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs, internal audit observations, and customer complaints. Escalation of quality issues as appropriate
- Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
- Responsible for pFMEA documentation and leading pFMEA meetings.
- Support Base Business and Production Improvement Initiatives
- Ensure that Test Methods and Quality procedures are executed in compliance with specifications and standards. Work in development, writing, updating and review of test methods, SOPs, protocols and specifications as required.
- Subject Matter Expert for Quality Engineering subjects during audits.
- Provide guidance to project teams and business partners to ensure compliance with company policies and procedures as well as medical device regulations.
- Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges. Work closely with R&D in support of development, validation and transfer of test methods to laboratory and/or production.
- Supports the development of quality strategies related to the transfer of products, materials and components within J&J or externally. Supports new product introduction as part of design transfer.
- Ensure effective quality strategies for Process, Test Method and CSV validation. Reviews process validation documentation (e.g. IQ, OQ, PQ and verification studies) and provide support during OQ and PQ validation. Supports engineering activities in process and vendor specification development.
- Execute/Manage Test Method and (Lab) Test Equipment lifecycle management (including development, validation & transfer).
- Monitor quality data and metrics on a regular basis to that ensure appropriate investigation, correction action, and/or escalation is conducted as required for recurring trends. Analyzes process-, product-, test-, Lab- and Quality Management System data and investigates for improvement opportunities.
- University/Bachelor’s Degree or Equivalent in Engineering or Science.
- Minimum of 4 years of experience in Quality.
- Experience with ISO 9000, ISO 13485 and GMP, knowledge of product/process Risk Management (FDA and ISO standards) is required
- Green Belt or Black Belt certification is desirable.
- Experience in Design, Process and Test Method validation.
- Quality and Statistical tools knowledge.
- Technical training and experience using Risk analysis (DFMEA, PFMEA), Statistics, Lean and Six Sigma Methodologies is required including Measurement System Analysis, DOEs, Gage R&R, etc.
- Knowledge of statistical software packages is preferred with the ability to preview, graph and analyze data in order to present data that facilitates/drives decision making.
- Understanding of the NPI (New Product Introduction) process and Process Validation expertise is preferred.
- Good level in written and spoken English. French is desirable.
- Proactive and able to take decisions.
- Well organized and systematic approach to issues.
- Able to work in a team.
- Able to identify and simplify complex issues.
- Good interpersonal, organization, and oral/written communication skills.
Ethicon SarL (8786)