Search Jobs
Quality Engineer
17221 Red Hill Avenue Irvine, CA 92614 US
Job Description
*Depending on experience
Summary:
The Quality Engineer will collaborate with a cross-functional design team to develop novel cardiovascular device/therapy, providing quality leadership and vision throughout the initial product development cycle up to commercialization, while ensuring compliance to 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 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.
Job Responsibilities:
• 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 project in compliance to appropriate external standards and corporate policies, to ensure critical to 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 project and across the organization
• Mentor engineers in 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 successful 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/ technician work.
Skills:
• 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 ability to apply to work product
• Strong technical and analytical engineering skills. Able to understand drawings and device design at a practical level.
• Excellent verbal and written communication skills. Able to communicate clearly and concisely yet thoroughly.
• Strong leadership skills and ability to influence change
• Ability to handle multiple tasks simultaneously.
• Must be accurate in handling detailed information/data.
• Experience in early human use 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.
Education/Experience:
• Bachelor's Degree or equivalent in Engineering with 4 years in related industry experience OR
• Master's Degree in Engineering with 3 years in related industry experience
The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.
Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
Share This Job:
Related Jobs:
About Irvine, CA
Are you sure you want to apply for this job?
Please take a moment to verify your personal information and resume are up-to-date before you apply.