Johnson & Johnson Careers
Staff Quality Engineer, New Product Development
Requisition ID: 2791180601
Biosense Webster, Inc., a Member of Johnson & Johnson's Family of Companies is recruiting for a Staff Quality Engineer, NPD for its wholly subsidiary Coherex Medical, to be located in Salt Lake City, UT.
If you want to work with brilliant people in a fast paced environment, help make a huge difference in patient’s lives and want to be responsible for providing the most innovative technology in the field of cardiac Left Atrial Appendage Closure, then Biosense Webster/Coherex Medical is the place for you!
Our products are used by prominent physicians around the world and help improve thousands of patient’s lives. Simply put, we are a highly innovative entrepreneurial company with a truly global and diverse culture, backed with the support structure of the Johnson & Johnson Corporation – quite a winning combination! Our commitment to quality and our Credo have helped us achieve significant milestones as a company.
- Participate, support, and lead activities related to suppliers of raw material, components, finished devices and services for the inspection of incoming materials, implementation of corrective/preventive actions, validations, certifications, qualifications and any project related to quality improvement
- Work with NPD and suppliers to ensure that the product or service received meets requirements and specifications. Responsible for generating quality standards and maintaining current standards. Develop and implement improvement programs for Coherex. Attend and participate in quality metric reviews.
- Perform and manage Quality Engineering duties related to new product introduction (NPI) and product lifecycle management -LCM (post-launch) activities for Pulsar Vascular.
- Function as the Quality team lead, thus, responsible for Product Risk Management (design, stability, and process) Post Market Surveillance, Cost reduction programs, Labeling, packaging, sterilization and product improvements, and supplier quality activities.
- Quality Engineering techniques shall be used, such as, risk analysis, test method development, statistical data analysis, statistical process control, and the development of sample plans.
- Review and approve project documents, strategies, as required.
- Support, lead and participate in CAPA activities as assigned.
- Establish proper planning for test method validations, while ensuring the development of appropriate test methods for product and process performance.
- Be responsible for the effective and consistent application of Quality Engineering, Process Excellence/Six Sigma tools and techniques, including active and thorough investigation of quality issues and effective corrective and/or preventive action.
- Effectively utilize Process Excellence to solve problems and develop optimal products and processes to ensure compliance with company policies and procedures as well as provide guidance and recommendations involving the implementation of regulatory requirements (e.g., Quality System Regulation, EU MDD, ISO standards, etc.).
- Partner with Research & Development, Product Management, and other cross-functional areas to ensure the application of design controls and design transfer are used.
- In collaboration with Research & Development, the Staff Quality Engineer will also assist with identifying Product Critical to Quality (CTQs) and ensure they are validated.
- Be responsible for partnering with Engineering and Suppliers to ensure the application of process validation, process control, and process risk management, are complying, as well as complete and assure the accurateness of investigations and corrections of process failures.
- Partner with Manufacturing Quality Engineering to implement and monitor process capability prior to Design transfer.
- Be responsible for providing proper review and direction during change control and continuous improvement activities for any changes that could affect the product design (form, fit, function and labeling requirements).
- If required, ensure supplier/OEM performance is monitored and addressed as needed, providing leading metrics to Quality Assurance and Regulatory Affairs Directors.
- Be responsible for Lifecycle Management Lead/Support, will partner with Operations Engineering and program management to maintain world-wide compliance.
- Be responsible to review, create and approve changes to procedures, work instructions, forms, specifications, inspection reports and other related controlled documentation. Support receiving inspection group to take actions when a nonconformance is received. Visit and evaluate suppliers thru audits or technical assessments. Responsible for communicating business related issues or opportunities to next management level.
- Be responsible for communicating business related issues or opportunities to next management level
- Be responsible for ensuring 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
- Be responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
- Work independently and in teams to accomplish their goals and objectives.
- Perform other duties assigned as needed
- A Bachelor’s degree is required.
- A minimum of 6 years relevant working experience with a minimum of 5 years quality engineering experience is required.
- A BA/BS degree (BS Engineering preferred) or equivalent in a Life Science, Engineering, or Physical Science is preferred.
- Familiarity with regulatory submission content (PMA/510(k)) is preferred.
- Medical Device experience is preferred.
- Familiarity with six sigma training and statistical tools is required.
- A Six Sigma Green Belt Certification and/or a Six Sigma Black Belt Certification is preferred.
- An ASQ Certification is preferred.
- Experience with New Product Introduction/Development is required.
- Experience collaborating with external suppliers is preferred.
- Experience with Design Controls is preferred.
- Experience with product reliability, reliability engineering and stability is preferred.
- Risk Management experience is preferred.
- Process Capability experience and Process Validation experience is required.
- A Demonstrated knowledge and application of industry regulations is required.
- QSR, MDD, ISO 13485, ISO 14971,cGMP, and other international standards is preferred.
- Data analysis (statistical analysis, sampling plans, Statistical Process Control, etc) experience is required.
- Experience with root cause investigations is required.
- Prior CAPA experience is preferred.
- Prior experience leading teams and/or having direct reports is preferred.
- Prior experience with statistical software is required.
- Proficiency in Minitab is preferred.
- The ability to work in a clean room environment is required.
- This position will be located in Salt Lake City, UT and may require up to 10% domestic and/or international travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
United States-Utah-Salt Lake City
Coherex Medical, Inc. (6226)