Design Quality Engineer

Design Quality Engineer (Product)

Location: Zuchwil, Switzerland

Hours: 40h, Hybrid way of working, on-site 3 days per week

DePuy Synthes, the Orthopaedics Company of Johnson & Johnson, provides one of the most comprehensive Orthopaedics portfolios in the world that helps heal and restore movement for the millions of patients we serve. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, in addition to the VELYS™ Digital Surgery portfolio, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. 

Building on our proud product innovation and legacy of industry firsts, we are reimagining the orthopaedic landscape with new advancements in medical technologies and digital surgery across the entire continuum of care to Keep People Moving today and tomorrow.

The role 

Support the New Product Development and Sustaining Design Quality Group for the TECA business, mainly for launching and sustaining orthopedic implants and associated instrumentation.

Significant contributor to a multi-discipline team in all aspects of the Quality System from new product development initiation to post-launch life cycle management.

May additionally support other company Quality Systems as needed once trained to the relevant procedures (i.e. Mitek, Crossroads).

This position interacts with other internal roles such as R&D, Regulatory, Marketing, Supplier Quality, Regulatory Compliance, Packaging, Sterility, Labeling.

Key responsibilities:

• Product development team member focused on product development and life cycle management activities related to the Trauma/CMF business.

• Lead design and development planning activities for new projects.

• Participate in all aspects of the creation and execution of functional/design requirements for new projects.

• Conduct formal technical design reviews throughout the phases of the product development process.

• Support and approve design verification/validation activities including mechanical testing, tolerance analyses, design rationales, and surgeon based anatomical labs.

• Apply statistical methods and design excellence tools to design verification and validation activities.

• Support risk management activities including planning, design & clinical risk management, production risk management, and overall risk benefit reporting.

• Lead the cascade of critical to quality design features to product quality plans and downstream manufacturing & quality processes.

• Support transfer to manufacturing activities both in product development and base businesses.

• Support product life cycle management activities such as design changes and cost improvement initiatives.

• Enhance the design control and risk management processes to better reflect state of the art practices and drive continuous improvement.

• Provide leadership in all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, nonconforming materials, risk management, and audit support functions.

• Provide leadership in the understanding of medical device regulations to other disciplines.

• Work closely with suppliers on the qualification of new parts and processes supporting product development.

• Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Product Development, Regulatory, Manufacturing, and Marketing.

• Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics, and compliance at all times.

• Diligently participate in our compliance program-related activities as denoted by your supervisor or our Chief Compliance Officer.

• 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.

• Performs other duties assigned as needed.

how to succeed:

• BS In Engineering and/or Technical Science 

• Strong working knowledge of QSR (21 CFR 820) and ISO (13485, 14971) quality requirements is preferred.

• Blueprint literacy including GD&T preferred.

• Knowledge of process and design excellence tools is strongly preferred. Certification is a plus.

• Excellent problem solving, decision-making, and root cause analysis skills.

• Interpersonal skills that foster conflict resolution as it relates to technical situations.

• Embrace teamwork, change, risk-based decision making and flexibility.

• Self-motivated to take action.

• Have excellent written and verbal communication skills.

• Proven track record implementing Quality System improvements to meet compliance and overall business goals.

• Proficiency with the Microsoft Office Suite is required.

Benefits

This role offers a competitive hourly rate & a supportive working environment. 

About Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

https://www.jnj.ch/

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. Please apply via the link.

Diversity, Equity & Inclusion

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 are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each 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”.