The Staff Quality Engineer applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and Edwards' systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. The Quality Engineer (QE) will focus on design control, design verification/validation failure analysis, FMEA, specification development, statistical reliability, quality/process control, acceptance sampling, and inspection/test methodologies. Will work in a fast paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success.
- Critical review and approval of design changes, partner with R&D in the design of safe and effective THV device.
- Partner with Manufacturing Engineers to develop critical manufacturing processes and provide technical quality support for the pilot production of clinical devices.
- Root cause analysis investigation for component and device non-conformances.
- Develop technical content of risk management files.
- Managing purchased component quality issues and working directly with suppliers.
- Oversee Quality support tasks; gives instruction to engineers/technicians on conducting tests; trains engineers/ technicians and provides feedback; and may coordinate engineers/ technician work.
- Provide technical quality support for design qualifications, design transfer, activities for Regulatory submissions, development and implementation of design control documents, presentations for design reviews, and approval of product/process changes.
- Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
- A Bachelor of Science degree in Mechanical, Biomedical, or equivalent engineeringdegree is required.
- Minimum of 6 years’ experience in Quality or Manufacturing is required.
- Knowledge of equipment qualification and design verification in the medical device industry or other regulated industries is required.
- ASQ Certified Quality Engineer (CQE) preferred with knowledge of Six Sigma concepts.
- Thorough knowledge of ISO design control regulations and FDA design Control QSRs.
- Working experience in medical device design control.
- Strong working understanding of failure analysis, FMEA, specification development, quality/process control, acceptance sampling, and inspection/test methodologies.
- Extensive knowledge and understanding of principles, theories, and concepts relevant to Quality Engineering (e.g., CQE body of knowledge).
- Working knowledge and understanding of statistical techniques, reliability, and acceptance sampling.
- Develops technical solutions to complex problems which require the regular use of creativity.
- Uses best practices and knowledge of internal or external business issues to improve products/services or processes.
- Ability to manage competing priorities in a fast-paced environment.
- Must be able to work effectively and collaborate within cross functional teams.
- Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non-technical personnel.
- Typically resolves complex problems or problems where precedent may not exist.
- Advanced problem-solving, organizational, analytical and critical thinking skills.
- Strong leadership skills and ability to influence change.