Process Transformation Engineer
Role Title: Process Transformation Engineer
Client: Depuy Synthes
Location: West Chester, PA
Mode: HCL Full Time
Salary: W2 + Benefits + Relocation Assistance
Work Authorization: Any VISA
- Quality Engineering/Design or Process Excellence/Lean experience is preferred. ASQ certifications are an asset.
- Strong engineering skills with working knowledge of: Process validation/verification activities.
- Knowledge of the QSR, Design Controls, and ISO quality requirements.
- A minimum of 5 years of related experience is required, preferably within a regulated environment (e.g. FDA regulated).
- Experience conducting Process / Design Failure Mode Effects and Analysis.
- Mechanical product knowledge is preferred. Problem solving techniques including 8D, root cause analysis and cause and effect analysis.
- Knowledge on Statistical techniques and methods.
- Experience with Blueprint reading/literacy including Geometric Dimensioning and Tolerance (GD&T
- Familiarity with inspection methods and techniques.
- Ability to use Quality Engineering principles, tools, and practices to develop and optimize systems and processes that are aligned with the overall business and quality vision is required.
- Engineering, Technical, or Scientific discipline is required. An advanced degree in a related field is an asset.
- Ability to work independently and partner with a cross-functional team (R&D, Regulatory, Manufacturing, and Purchasing).
- Excellent negotiation, decision-making, and interpersonal skills that foster conflict resolution as it relates to technical situations is desired.
- Working knowledge of Microsoft office products (Word, Excel, Access, and Project).
- Excellent written and oral communication skills.
- Experience in CAPA execution and management