Quality Engineer II - 100 at Flexible & Integrated Technical Services, LLC

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Full Time

Start Date

Immediate

Expiry Date

04 Mar, 26

Salary

0.0

Posted On

04 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Standards, Statistical Analysis, Technical Writing, Risk Management, Root Cause Analysis, CAPA, Process Validation, Equipment Documentation, Critical Thinking, Investigations, Manufacturing Defects, Validation Strategies, Collaboration, Communication Skills, Bilingual, Minitab

Industry

Pharmaceutical Manufacturing

Description

For Industrial services in the Manufacturing area. WHAT MAKES YOU A FIT: The Technical Part: Bachelor’s Degree in Engineering (Preferred Mechanical, Electrical, or Chemical) and Three (3) years of experience within the Medical Devices Industry. Bilingual: Spanish and English Soft Skills: Writing and communication skills Shift: 1st, 2nd, and according to business needs. Experience in: CAPA, Investigations, Root Cause Analyses, and Technical Writing. Risk Management (pfmea), and Critical Thinking. Process, Computer validations (not cleaning processes), and Equipment document: URS, FAT, IQ, OQ, PQ. Minitab (statistical analysis). The Personality Part: Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece? AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) Develops, modifies, applies, and maintains quality standards. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Develop and implement methods and procedures for inspecting, testing, and evaluating products and production equipment. Performs statistical analysis. Ensures that documentation is compliant with requirements. May specialize in the areas of design, production control, product evaluation, and reliability, as they apply to product or process quality. Investigating manufacturing operations events in support of product disposition. Assessing and tracing manufacturing defects/rejects trends. Designing validation strategies (e.g, requirements flow down from design to manufacturing). Statistical techniques to analyze data capable of developing, reviewing, and approving test plans and reports. WHO WE ARE: We are a Service Provider company different from the rest. We pride ourselves on how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on our resources' well-being, while providing our Pharmaceutical, Medical Devic,e and Manufacturing industry clients with top-notch quality talent. We're FITS! Are you the Next Piece?

Responsibilities

Develop and maintain quality standards while collaborating with engineering and manufacturing functions. Implement methods for inspecting, testing, and evaluating products and production equipment.