Edwards Lifesciences is looking to solve moderately complex manufacturing product quality and compliance issues, optimize manufacturing processes, and ensure compliance with regulatory requirements.
Requirements
- Proven expertise in Quality Engineering, Quality Management, or Regulatory Compliance (medical device industry preferred)
- Basic understanding of statistical techniques
- Solid understanding and knowledge of principles, theories, and concepts relevant to Engineering
- Solid understanding of processes and equipment used in assigned work
- Knowledge of and adherence to Quality systems
Responsibilities
- Investigate moderately complex manufacturing product quality and compliance issues (e.g., CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.
- Optimize to optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement.
- Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk
- Develop, update, and maintain technical content of risk management files
- Develop training and documentation materials for production (e.g., work instructions) to enable the seamless knowledge transfer of project and manufacturing processes
- Assign support tasks; gives instruction to technicians on conducting tests; trains technicians and provides feedback; and may coordinate technician work.
Other
- Bachelor’s degree in Engineering or a Scientific field with 2 years of related experience, or a Master’s degree with relevant academic or industry project work.
- a strong track record of leading technical or engineering teams in regulated environments.
- Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
- Solid problem-solving, organizational, analytical and critical thinking skills
- Strict attention to detail
