"Caring for the world… one person at a time” … inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo
DePuy Synthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we created one organization that will be agile and better equipped in today’s evolving health care environment. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world.
For our site in Grenchen we are looking for an experienced
Quality Engineer (m/f)
1. Overall responsibilities
The Quality Engineer conducts assignments encompassing complete projects or portions of major projects. They determine methods and techniques to be used or adapt standard methods to meet variations.They coordinate phases of work internally and externally. The Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product lifecycle. The incumbent will also utilize Quality Engineering principles and problem solving skills to improve and maintain products /processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. This person will support processes in base business.
2. Position duties and responsibilities
— Support quality improvement initiatives such as process and product characterizations that lead to
continuous / cost improvements.
— Review/analyze the effectiveness of PDCA, Six Sigma, Kaizen, Lean Techniques and/or other
improvement tools and programs.
— Conduct benchmarking to develop more effective methods for improving quality
— Supports the development of quality engineering and quality compliance with the right skill sets for new product introductions, and product life cycle management.
— Review/analyze whether current product and processes (including actions or decisions conducted)
are in compliance to standards such as the QSRs, ISO 13485, etc.
— Champions compliance to applicable Global Regulations and standards (e.g. QSRs, ISO, EN and
Medical Device Directive (MDD) requirements) including providing support during internal and
— Conduct periodic line audits to assess for production controls such as lot segregation. Review
results of area audits to ensure that corrective and preventive actions are adequate.
New Product/Process Introduction
— 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.
— Supports new product introduction as part of design transfer.
Product Quality, Control & Disposition and Performance Standards
— Supports activities related to the Material Review Board.
— Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
— Accountability and ownership for material identification, material segregation, classification of defect types including the successful application of these techniques on a day-to-day basis in manufacturing.
— Analyze/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
— Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality Product/Process Qualification
— Approve IQ, OQ, PQ, TMV or Software Validation Production/Process Controls including Control Plans
— Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
— Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
— Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
— Develop, interpret and implement standard and non-standard sampling plans
— Assess effectiveness of measurement tools, destructive tests, non-destructive tests, measurement system analysis.
— Assess and interpret common versus special cause variation in manufacturing processing and
determine adequacy of current process limits.
— Document, justify, review or analyze whether a proposed change to a process will not enhance the
risk level in some way beyond capability of current controls or whether change will result in
potential non-compliance to a required standard such as the QSRs
— 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
— Ensures effective quality strategies are created for the validation of test methods, process and
— A minimum of a Bachelor’s Degree, preferably in Engineering or related technical field.
— In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
— Generally requires 2-4 years related experience.
— Experience working in both an FDA and European regulatory environment is preferred.
— This position will require relevant experience working in manufacturing/operations.
— Technical training and experience using Statistics, Lean and Six Sigma Methodologies is preferred
including Measurement System Analysis, SPC, DOEs, Reliability, etc.
— Experience with a proven track record of implementing appropriate risk mitigation.
— Strong 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.
— The ability to perform "hands on" troubleshooting and problem solving is preferred. The ability to
think on the feet and providing sound judgment is highly desired.
— Good technical understanding of manufacturing equipment and processes is required.
— Understanding of the NPI (New Product Introduction) process and Process Validation expertise is
— A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
— Advanced knowledge and experience in the areas listed in the Duties and Responsibilities
associated with the position.
— Demonstrated project management and project leadership abilities are preferred.
German: Very good English: Very good
Synthes Produktions GmbH (7117)Job Function
Quality (Eng)Requisition ID