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.
Quality Engineer - Internship
- 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
- 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
- Project management and
- Abililty to work in a
- 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
- 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
- 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.
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 Quality
Management System data and investigates for improvement opportunities.