* Optimize systems and processes that are aligned with Mentor Medical System's strategy and mission effecting continuous quality improvement.
DUTIES & RESPONSIBILITIES
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
* Supports, consults, trains on, and leads quality improvement projects throughout the life cycle of Mentor products this includes product design and development, manufacturing, purchasing and improvements.
* Utilize statistical tools and techniques to establish sampling plans. Supports engineering activities in process and vendor specification development.
* Analyzes process-, product-, test- and Quality Management System data and investigates for improvement opportunities.
* Responsible for pFMEA documentation and leading pFMEA meetings.
* Reviews validations documentation (eg. IQ, OQ, PQ and verification studies).
* Leads or is team member of CAPA investigation and action plans.
* Leads or is team member of Internal audit observation investigation and action plans.
* Investigate instances of nonconforming material and supports the determination of cause, corrective action and recommendation of the disposition of product.
* Ensures that software validations are performed according to applicable FDA guidelines. Provides end user support by software validation throughout the Software Validation Life Cycle at The Netherlands Operations.
* Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
EXPERIENCE AND EDUCATION
* Bachelor's degree (B.S.) in engineering, science, mathematics or statistics is required.
* A minimum of three years related manufacturing experience and/or training; or equivalent combination of education and experience is desired;
* Demonstrated knowledge of good manufacturing principles and practices, and procedures;
- Able to work on cross-functional teams is required. Must also be able to communicate effectively within diverse interdepartmental groups.
- Six Sigma Blackbelt or Greenbelt certification preferred.
- Strong plus: experience in microbiology sterilisation