Location: Anasco, PR

Responsibilities

• Develop, implement, and maintain quality programs in an FDA-regulated environment.
• Plan, control, and assure product and process quality in accordance with established quality principles.
• Develop and execute validation activities, including:
• Validation Protocols
• Validation Plans
• Process Validation documentation
• Technical and Investigation Reports
• Standard Operating Procedures (SOPs)
• Change Controls
• Other technical and quality documentation as required
• Support the qualification of new facility additions and systems, including HVAC and water filtration systems.
• Apply Quality System Regulation (QSR), ISO, Design Control, and Process Validation requirements to quality activities.
• Develop, document, and implement quality systems in accordance with domestic and international standards and regulatory requirements.
• Participate in and support audits, including audit planning, preparation, execution, reporting, and follow-up activities.
• Track, analyze, and report quality metrics and use data-driven approaches to identify and resolve problems.
• Apply quality improvement and problem-solving tools and techniques to improve products and processes.
• Plan and support material controls, acceptance sampling, measurement systems, and other product/process quality activities.
• Apply statistical methods and tools, including Statistical Process Control (SPC), Design of Experiments (DOE), Process Capability, and Gage R&R.
• Acquire and analyze data using appropriate quantitative methods to facilitate process analysis and continuous improvement.
• Apply Lean and Six Sigma principles to quality and process improvement initiatives.
• Support risk management, reliability, and maintainability activities, including assessments and reporting.
• Collaborate effectively with cross-functional teams to resolve quality issues and implement improvements.
• Manage quality-related projects, priorities, and deliverables while maintaining strong documentation and communication.
• Apply strong technical writing skills to prepare clear, accurate, and compliant documentation.
• Utilize statistical and business software tools, including.

Qualifications / Requirements

• Bachelor’s degree in Chemical, Biomedical, Mechanical, Industrial Engineering, or a related engineering discipline.
• Minimum of 5–7 years of experience in an FDA-regulated environment.
• Prior experience working in ISO-compliant cleanrooms required.
• Experience with Quality System Regulation (QSR), ISO standards, Design Control, and Process Validation.
• Fundamental understanding of quality systems, including development, documentation, implementation, and maintenance in accordance with domestic and international standards and requirements.
• Basic understanding of the audit process, including audit planning, preparation, execution, reporting, and follow-up.
• Knowledge of quality planning, material control, acceptance sampling, and measurement systems.
• Knowledge of reliability, maintainability, and risk management principles, including assessment tools and reporting.
• Thorough understanding of problem-solving and quality improvement tools and techniques.
• Knowledge of Lean and Six Sigma concepts.
• Knowledge of statistical techniques, including SPC, DOE, Process Capability, and Gage R&R.
• Strong problem-solving and analytical thinking skills.
• Strong project management skills.
• Strong technical writing skills.
• Strong interpersonal and communication skills.
• Ability to interact effectively with cross-functional teams.
• Team-oriented and self-starter with the ability to work independently.
• Fully bilingual in English and Spanish

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.The pay rate for this position is $43.01/hr.