Quality Engineer III_US

Job Title: Quality Engineer III_US
Location (On-site, Remote, or Hybrid?): Anasco, PR
Contract Duration: 1 year

Description:
The requirements listed below are representative of the knowledge, skill, and/or ability required for this QE position:

• Must have prior experience with ISO cleanrooms
• BS in Chemical, Biomedical, Mechanical, or Industrial Engineering
• 5 to 7 years minimum experience in an FDA regulated environment.
• ASQ Certified Quality Engineer (CQE) and/or Quality Auditor (CQA) preferred.
• Experience with Quality System Regulation (QSR), ISO, Design Control and Process Validation guidelines.
• Lyophilization preferred
• Knowledge of qualifying new facility additions - HVAC, water filter systems
• med device experience preferred not required
• Able to develop technical documentation such as: Validation Protocols, Technical / investigation reports, SOP, Validation Plans, Change Controls, and others.
• Will have a fundamental understanding of a quality system and its development, documentation and implementation to domestic and international standards or requirements.
• Will have a basic understanding of the audit process including types of audits, planning, preparation, execution, reporting results and follow-up.
• Will be able to develop and implement quality programs, including tracking, analyzing, reporting and problem solving.
• Will be able to plan, control and assure product and process quality in accordance with quality principles, which include planning processes, material control, acceptance sampling and measurement systems.
• Will have basic knowledge of reliability, maintainability, and risk management, including key terms and definitions, assessment tools and reporting.
• Will have a thorough understanding of problem-solving and quality improvement tools and techniques.
• Will be able to acquire and analyze data using appropriate standard quantitative methods across a spectrum of business environments to facilitate process analysis and improvements.
• Problem solving and analytical thinking skills
• Strong Project Management skills
• Strong skills in technical writing
• Knowledge in Lean and Six Sigma concepts
• Knowledge of statistical techniques: SPC, DOE, Process Capability and Gage R & R, etc.
• Use of statistical process Minitab tools is preferred.
• Working knowledge of computers and business software (MS Office, MS Project, VISIO) required.
• Experience in biomaterials preferred.
• Experience in cGMP, cleaning methods and validations preferred.
• Ability to interact cross-functionally required.
• Strong interpersonal skills
• Teamwork oriented and self-starter
• Fully bilingual (English/Spanish)