- Entry level
- No Education
- Salary to negotiate
Caring for the world, one person at the time, has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science – bringing innovative ideas, products and services to advance the health and well-being of people.
Johnson & Johnson is one of the leading health care companies in the world, with over 6,000 people working for Johnson & Johnson companies in Switzerland. Johnson & Johnson’s footprint covers sites and companies across three of its sectors - Consumer Health Care, Medical Devices and Pharmaceuticals businesses, situated in a number of locations across Switzerland.
Junior Quality Engineer - Internship
Job requirements (education, background skills, personal aptitudes / skills)
University level in Engineering or Science
Experience with ISO 9000, ISO 13485 and GMP, knowledge of product/process Risk Management (FDA and ISO standards) is advantageous
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 and be able to present data that facilitates/drives decision making.
Project management and resource prioritization
Abililty to work in a team environment
People development - Ability to communicate across multiple levels in the organization
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 (eg. 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
About the company
If you’re thinking about taking your career to a place where you can be seen for the talent you bring to your work, where you’ll have a chance to be the driver of your own career, and where others share your passion for caring and success, then we invite you to explore Johnson & Johnson. BE VITAL in your career and make a unique mark. Join the approximately 129,000 men and women who work within our companies and touch the lives of more than a billion people around the world every day.