Qualification Required:

• (BS) in Science, Mechanical/Industrial/Biomedical engineering

Roles And Responsibilities

Provide ongoing quality engineering support throughout the product life cycle.

• Provide support to development, engineering and manufacturing functions for validation planning and transfer activities.
• Assist teams in determining validation needs, strategies, and requirements.
• Ensure product development and validation programs meet requirements of FDA and ISO when applicable.
• Experience in Lean Six Sigma, Kaizen, or other problem-solving methodologies is an advantage.
• Drive process risk management activities and ensure quality and completeness of project device history records, validation packages, and change orders.
• Lead the implementation of process controls, and CAPA systems designed to meet or exceed internal and external requirements.
• Proficient in using statistical techniques such as control charts, process capability, sampling plans, gage R&R.
• Manage Quality Notifications (QN) for non-conforming product and deviations.
• Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion.
• Trend, analyze, and report on quality data to improve product and process; develop recommendations based on data analysis.
• Knowledgeable on 21CFR 820, EU MDR, ISO 13485, ISO 14971.

Required Technical And Professional Expertise:

Engineering Project Manager, Manufacturing environment, Process Validation, PFMEA, Control Plans, Gage R&R, Manufacturing Process Development, IQ/OQ/PQ, Quality Assurance, Quality Notifications