Edwards Lifesciences is looking to solve moderately complex manufacturing product quality and compliance issues, optimize manufacturing processes, and ensure compliance with regulatory requirements.
Requirements
- 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 which may include:
- Investigate PRAs and complaints for manufacturing related issues
- Manage site NCRs, CAPAs , ECRs and audit observations for all production processes prior to final product release based on engineering principles; analyze results,
- Provide technical support to external land internal audits,
- Oversee product release, assess and disposition product onhold (MRB), and manage material quality control.
- Review and approve equipment validations and asset management actions.
- Optimize to optimize moderately complex Manufacturing processes using engineering methods (e.g., SIX Sigma, TOPP and LEAN methods) for design for manufacturing and for continuous process improvement.
Other
- Bachelor’s degree in Engineering or a scientific field with 2 years of related experience, or Master’s degree with relevant internship, senior project, or thesis experience in industry or academia.
- Good documentation, communication and interpersonal relationship skills including negotiating and relationship management skills
- Strict attention to detail
- Ability to interact professionally with all organizational levels
- Ability to manage competing priorities in a fast paced environment
