Title:  Quality Technician

Job Summary

Responsible for ensuring product quality through a prevention base based on quality initiatives including: finished product process inspections, raw material inspections, active participation in work teams to identify and correct defects. Ensures consistency in the execution of procedures to achieve department goals, direct support in new product validations, or improvement of existing product processes. Complete and maintain the necessary documentation to ensure compliance with product specifications and traceability of manufacturing records.

Essential Duties and Responsibilities

• Inspects work-in-process components to ensure compliance with customer specifications, ensuring that only approved and certified material is ready for storage or use in production. Releases components for production use and audits manufacturing areas to ensure compliance with procedures.
• Audits and approves manufacturing records and executes final product release.
• Interprets specifications and procedures, uses testing and measurement equipment as established in the Quality Plan, and utilizes quality control techniques as required.

• Inspects and tests all materials as required, according to the Raw Material Receiving Procedure. Identifies, segregates, and disposes of raw materials that are out of specification. If required, supports the Engineering department in validation activities and the correct use of measuring and process equipment. Participates in Mold Transfer Teams.
• Assists in the implementation of training for staff at all levels to raise awareness and ensure compliance with the Quality System.
• Works as a team with the production area to develop corrective action plans when necessary. Together with the Quality Supervisor or Quality Engineer, provides technical support and identifies areas for continuous improvement to reduce non-conforming products.

• Follows established health and safety rules for accident prevention. Ensures compliance with applicable ISO standards.
• Works in an environment that complies with GMP and GDP standards. Provides support during training and external and internal audits and ensures that required documentation complies with Good Manufacturing Practices, ISO 13485, and all Quality systems. Supports the organization's Lean and Six Sigma initiatives.
• Performs any other tasks not included in the scope of the duties assigned by the Supervisor/Manager based on company needs, as long as they do not compromise employee safety or integrity.

Preferred Qualifications

• Associate's degree or equivalent from an accredited university institution.
• At least 4 years of experience in quality auditing and inspection processes in production processes.
• Management of product identification and date review processes.
 

Language Skills:
• Good oral and written communication skills.
• Able to efficiently write memos, instructions, and quality reports.
 

Mathematical Skills:
• Able to perform mathematical processes such as:
o Addition, subtraction, multiplication, and division of whole numbers, decimals, and fractions.
o Calculate percentages and ratios.
• Experience with measuring equipment such as calipers, micrometers, pin gauges, vision equipment, and weight scales.
• Basic skills with SPC tools.

Computer Skills:
• Knowledge of MS Word, Excel, Outlook, and Teams software.
• Knowledge of MRP programs such as QAD and SAP.
 

Interpersonal Relationships:
• Internal: Supervisors, managers, production operators, molding technicians.
• External: External auditors, suppliers.

Additional Preferred Qualifications

• Experience working in FDA-regulated industries.

Physical Requirements & Travel

• No travel outside of Puerto Rico is required.

Additional Requirements

• Ability to learn, understand, and remember normal tasks.
• Ability to hear, speak, and understand conversation in English in a normal tone of voice.
• Must maintain the ability to work well with others in a variety of situations.
• Must be able to multi-task, work under time constraints, problem solve, and prioritize.
• Read and interpret data, information and documents
• Work under deadlines with constant interruptions