SUPPLIER QUALITY ENGINEER
Seeking a Supplier Quality Engineer with experience in the pharmaceutical and medical devices industries. The candidate must have solid GMP and regulatory experience.
Duties & Responsibilities
Skills and Specifications
- The Supplier Quality Engineer will spent more than half of the time in MSA and PPAPs.
- The Supplier Quality Engineer will be responsible of Attribute Charts/Incoming Inspection Procedures, Component Failure Mode & Effects Analysis (CFMEA), Engineering Prints, Gage R&R validations, Minitab Assessment, Non Conformance Documentation, Quality Inspection Procedures (QIP), Sterilization Validation, Supplier Validation – Component Qualification, Work Instructions (TI’s or PPM).
- The Supplier Quality Engineer will support Equipment Qualification, Fixture / Equipment Prints, Packaging Validation (including Sealing Validation), Process Characterization, Process Failure Mode & Effects Analysis (PFMEA), Process Validation (PC, Test Method, OQ-P, Overall Process Validation), other tasks may be assigned.
- Quality Assurance experience
- Read and interpret prints
- GD&T knowledge highly desirable
- Validation experience
- Bilingual (English & Spanish)
3+years of experience in a similar or related role
Bachelor in Engineering (BSME, BSEE, BSChE, BSIE preferred)
Ultimate Solutions Corp is an equal opportunity employer.
- Problem Solving
- Sense of urgency
- Detail Oriented
- Be flexible enough to travel to job sites when need arises.
- Willing to work overtime including weekend depending ion the nature of work available.
- Able to work with minimum or no supervision
- Strong interpersonal skills and must work in a team