Optimize systems and processes that are aligned with Mentor’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.
- 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.
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;
- Shown knowledge of good manufacturing principles and practices, and procedures;
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS
Able to work on multi-functional teams is required. CQE certification, Six Sigma Blackbelt or Greenbelt certifications are preferred.
Able to communicate effectively within diverse interdepartmental groups.
- Primary location of the position – Mentor LLC, Leiden, The Netherlands
The position may require interactions with government agencies, competent authorities, third part suppliers or customers of J&J.
Mentor Medical Systems, B.V. (8808)