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**Job Function: **
Quality
**Job Sub Function: **
R&D/Scientific Quality
Job Category:
Professional
All Job Posting Locations:
Zuchwil, Switzerland
Job Description:
**Purpose: **Support the New Product Development and Sustaining Design Quality Group for the TECA business, mainly for launching and sustaining orthopedic implants and associated instrumentation.
You will be responsible for:
- 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 support 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.
- 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.
Qualifications/Requirements:
- Education: B.S. in Engineering and/or in a Technical Science
- Minimum of 1 year experience in a GMP and/or ISO regulated industry is required (internships, co-ops, practical experience).
- New product development experience or previous experience in a medical device or a healthcare discipline is preferred.
Preferred:
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.
New product development experience or previous experience in a medical device or a healthcare discipline is preferred.
**Required Skills: **
Preferred Skills:
Agility Jumps, Business Behavior, Compliance Management, Continuous Improvement, Database Backup, Data Gathering and Analysis, Data Savvy, Disruptive Innovations, Execution Focus, Issue Escalation, Process Oriented, Product Improvements, Quality Control (QC), Quality Control Testing, Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Report Writing