Staff Quality Engineer.

Job content

Caring for the world… one person at a time” inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo.

DePuy SynthesCompanies 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. Our broad array of inspired, innovative and high-quality offerings, help advance the health and wellbeing of people around the world.

We Are Looking For a Highly Committed

Staff Quality Engineer based in Neuchâtel

(Permanent)

Overview

Staff Quality Engineer resides under the Supply Chain Quality structure and reports to the Quality Operations Manager. Under the direction of the Quality Operations Manager and with the objective of maintaining high quality standards of the product manufacturing process and compliance with regulatory requirements, supports Quality Operations in day-to-day activities supporting the site business for adequate quality support, documentation review, support projects, use engineering principles, tools and techniques to develop, optimize, and support systems and processes that are aligned with the overall company strategy and mission affecting continuous quality improvement, prepares, conducts, monitors and reports on audits of all quality system categories to assess compliance to good manufacturing practices, equipment engineering system, and international organization for standardization standards.

Further Responsibilities And Duties Are

Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Support the leading of Quality Operations department to ensure all quality objectives and goals are met and help develop and drive strategic direction of the organization in the areas of quality operations and compliance.
• Capable of developing quality engineers and quality technicians in the use of Process Excellence tools and Quality Systems to make data driven, risk-based decisions that ensure the quality of the product.
• Support, consult, train and lead quality improvement projects throughout the life cycle of Ethicon products, including product design and development, and manufacturing.
• Utilize Quality Engineering tools and techniques to establish sampling plans, develop quality plans, conduct and participate in FMEA activities, support reliability engineering activities, conduct process and systems audits and support specification development.
• Analyzes routine and test data looking for improvement opportunities. Designs and implements experiments (DOE’s) for process and product improvement and validation testing.
• Provides with the subject matter expertise and support for sampling plan analysis, DOEs, Pareto, ANOVA, and SPC applications, and other statistical applications as required.
• Evaluate manufacturing quality performance capability and develop criteria to monitor and improve existing processes.
• Serves as technical review for validation activities, i.e. protocols and reports.
• Investigate nonconforming material and the determination of cause, corrective action and recommendation of disposition. Apply research and benchmarking activities to create innovative solutions, validate their effectiveness and facilitate their implementation.
• Develop personal performance objectives based upon the facility quality objectives, reporting monthly on progress made against those goals. Prioritizes work to achieve deadlines.
• Comprehension of the quality System Regulation (21 CFR PART 820), ISO 13485 requirements, MDD, Canadian Regulation and other applicable regulations.
• Serves as the Quality Engineering expert on assigned responsibility areas and has conceptual understanding of all Quality functions and business areas.
• Conduct strategic planning with site leaders and Engineering Team. Partnership with other functions to establish business priorities and resource allocation.
• Ensures effective quality strategies are created for the validation of test methods, process and design.
• Perform/support Internal Audits to ensure compliance with QSR, ISO 13485, MDD and Canadian Regulation in accordance with the Internal Audit schedule.
• Support the nonconformance investigation and bounding of nonconforming product through the Nonconforming System.
• Responsible for communicating business related issues or opportunities to next management level.
• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
• Support all new product introductions to include process validation of new processes and/or process confirmations for changes to processes that are within the validated parameters.
• Performs other duties assigned, as needed.
  
  

Additional duties and responsibilities as part of Ethicon Sarl Legal Manufacturer for products manufactured in Ethicon San Lorenzo, Puerto Rico:

• Ensures that performance and quality of products conform to established company and regulatory standards.
• Assist in ensuring the safety, performance, and integrity of products at all stages of the manufacturing, distribution process and end-to-end supply chain.
• Initiates and maintains interplant communication of quality issues.
• Assures compliance with all local government regulatory requirements and requirements related to sampling plans, design control, and quality systems.
• Coordinates and oversees activities related to internal and external audits to assure compliance with company, state, federal, and international standards.
• Co-host external audits/inspections for the site and/or supports the audits.
• Responsible for communicating business related issues or opportunities to next management level.
• Utilize quality engineering principles and problem-solving skills to develop and optimize products/processes that are aligned with the overall Quality and Business vision.
  
  

Qualifications

• University/Bachelor’s Degree or Equivalent in Engineering or Science.
• Minimum of 5 years of experience in Operations, Engineering and/or Quality Assurance is required.
• 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 are preferred.
• 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.
• Demonstrated influential, leadership skills, and able to work on cross-functional teams are required.
• Demonstrated project management skills with strong results orientation, required.
• 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 identify and simplify complex issues.
• Good interpersonal, organization, and oral/written communication skills.
  
  

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we in Switzerland are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!

If you want to be a change agent in a challenging environment and shape the future quality organization, please send us your online application (CV, Motivation Letter, Working References etc.).

Primary Location

Switzerland-Neuchâtel-Neuchâtel-

Organization

Ethicon SarL (8786)

Job Function

Engineering

Requisition ID

2206026764W