Senior Quality Engineer
22 Days Old
- Collaborate with a cross-functional design team to develop Client cardiovascular device/therapy, providing quality leadership and vision throughout the initial product development cycle up to commercialization, while ensuring compliance with applicable internal and external requirements.
- In this position, the engineer will work closely with R&D to define strategy, as well as refine and finalize the design per the NPD process. In addition, the engineer will work with the Operations team to help facilitate the successful transfer/launching of robust products.
- This position provides an opportunity to work in a fast-paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success.
- Collaborate with the R&D and Operations teams in the areas of Design Engineering, Risk Management, Design Controls, Design Verification, Statistical Techniques, Test Method Development, Process Development, Quality Assurance, and Regulatory Compliance.
- Lead Risk Management process for the project in compliance with appropriate external standards and corporate policies, to ensure critical quality features are identified and addressed appropriately.
- Responsible for creating and maintaining risk management documentation such as risk management worksheet, FMEAs in alignment with ISO:14971.
- Provide integral technical input for the development of project plans, project timelines and strategy to support premarket approval of products.
- Partner with R&D engineers to support design verification/validation strategy and testing, including test method development/validation activities. Strong leadership and collaboration with other leaders in the project and across the organization.
- Mentor engineers in the understanding of quality systems and strategies within new product development.
- Support root cause investigations/product evaluations for product failures encountered during clinical use using engineering methods (Six Sigma, DMAIC, etc.).
- Support resolution of manufacturing and compliance issues (i.e. CAPA, non-conformances, audit observations, etc.) utilizing problem-solving tools.
- Support Quality Engineering activities to improve customer satisfaction and the achievement of company quality objectives.
- Responsible for ensuring compliance with all National/Federal, local, and company regulations, policies and procedures.
- Train, coach, and guide lower-level employees on more complex procedures.
- Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/technicians' work.
- In-depth knowledge of Design Control, Risk Management, and related standards, as applicable for medical devices.
- Knowledge of Quality Engineering and Six Sigma concepts with the ability to apply to work product.
- Strong technical and analytical engineering skills.
- ble to understand drawings and device design at a practical level.
- Excellent verbal and written communication skills.
- ble to communicate clearly and concisely yet thoroughly.
- Strong leadership skills and ability to influence change.
- bility to handle multiple tasks simultaneously.
- Must be accurate in handling detailed information/data.
- Experience in early human use of NPD strongly preferred.
- Experience in Design for Manufacturing (DFM) preferred.
- Certified Six Sigma Black belt / CQE preferred.
- Experience with electronic devices, data transmission/acquisition a plus.
- Microsoft Office, Minitab.
- NPD experience as Quality/Design Assurance in Early Human Use, ISO 13485, ISO 14971.
- Experience in early medical device development as Design Assurance/Quality Engineer, results-driven, flexible and critical thinking.
- Design control in medical devices, NPD Quality Assurance, Risk Management.
- Design Six Sigma, ISO 14971, Early Human Use.
- Bachelor's Degree or equivalent in Engineering with 4 years of related industry experience OR master's degree in engineering with 3 years of related industry experience.
- Location:
- Irvine
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