Quality Engineer I - Medical Industry

Responsibilities

• Verify the company's compliance with the established Quality System and with GMP/ISO standards.
• Provide support in performing risk management and risk analysis, including FMEA.
• Support technical and statistical investigations related to optimization and compliance with specifications.
• Assist in process capability measurement, process controls, and process validation efforts.
• Work with the microbiology area to ensure adequate environmental monitoring and ensure that microbiological requirements are considered in product and process development activities.
• Perform NCMR investigations, Out of Tolerance (OOT) Calibration investigations, and Complaint Investigations (MA) related to the manufacturing process.
• Complete and document the Monthly Quality Data Review.
• Lead Build At Risk (BAR) Authorizations and Closures.
• Complete and approve document Change Requests, ensuring accuracy, sufficiency, and compliance with the Quality System and product requirements.
• Create and maintain Quality Plans and Reports, generally with mentorship from senior-level engineering.
• Execute IQ, OQ, PQ, and/or PPQ qualifications and Inspection and Test Method qualifications, typically with mentorship from senior-level engineering.
• Perform advanced statistical analysis using Minitab, generally with mentorship from senior-level engineering.
• Maintain and update Validation Master Plans and Reports.
• Provide support for major Quality System investigations (e.g., CAPAs, HHEs, StopShip, etc.).
• Support activities during the preparation and execution of audits (External / Internal).
• Perform other tasks and responsibilities assigned by upper management.

Knowledge Area:

• Works in close collaboration with Manufacturing and Engineering in sustaining activities to ensure compliance with quality system requirements and the achievement of Key Performance Indicators (e.g., NCMRs, MAs, yield, cost reduction projects, etc.), in addition to supporting process and product validation activities.
• Collaborates with Research and Development and Regulatory Affairs personnel (internal or external) to obtain support in sustaining activities that ensure compliance with product and regulatory requirements.
• Provides support for major Quality System investigations (such as CAPAs, HHEs, StopShip, etc.) and audits (External / Internal).

Requirements

Education: Bachelor's degree in Engineering or related field. Experience: Minimum 1 year in Quality or Engineering positions.

Knowledge

• Computer applications (MS Excel, Word, PowerPoint).
• Statistical analysis and report writing.
• Regulated environments FDA, GMP, ISO 13485.
• Process improvement tools (Root Cause Analysis, Fishbone, Six Sigma, SPC).
• Non-conforming material control, corrective and preventive actions.
• Qualification and validation of processes and products.

Language: Intermediate English.

Requirements

• Minimum education: Bachelor's / High School years of experience

Keywords: calidad, quality, qa, ingeniero, engineers, ingeniera, ing, engineer, industry, industrial, industria