.Operating Company: SparkLocation: Mexicali,Baja California,MXDate Posted: November 19, 2024Req Number: R5021287**SUMMARY**: The Process Engineer is responsible to assure that all digital process for treatment planning are align with the Quality management system. It is charged of monitoring and assessing Digital Production cases for quality, efficiency, and performance maintenance and improvement. Provides execution of QA tasks with speed and great quality for the overall agility of the QA team.Create and implement new regulatory standard operating procedures, and/or propose revisions and/or act as reviewer for regulatory standard operating procedures, as assigned and appropriate.**PRIMARY DUTIES AND RESPONSIBILITIES**: including the following and other duties as assigned.- Responsible for planning, implementing, and managing compliance of internal quality processes in alignment with external, quality and regulatory standards requirements.- In charge of establishing good documentation practices and process for each Design operation or department within the quality management system.- Provide coaching and feedback to the designers and Staff members on QA main indicators trends.- This position may have people in charge, will coach and support pears and engineers as required.- Send weekly report on trends that are found during their interactions while reviewing design treatment plans, clinical investigations, Manufacturing issues, and complaints from customers.- Provides support to business entities aligning and adopting Quality Policies/Processes.- Performs analysis of quality system data to identify trends and recommend updates or changes to quality standards and procedures when necessary.- Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors- Exercises independent judgment in methods, techniques and evaluation criteria for obtaining results- Assist in recommending constructive ideas for improving scripts, programs, and processes.- Networks with key contacts outside own area of expertise- Lead special projects as needed.- Address customer and team needs in a timely manner.**Job Requirements**:- Proficient in Microsoft Office Package- Proficient in using Electronic Document Management Systems- Experience in designing, execution, and measurement of quality processes- Experience in investigation methodology and root cause analysis (5 Why's, Fishbone etc.)- Experience in statistical analysis methodology / data analysis- Excellent Verbal and Written Skills (English), and interpersonal skills**PREFERRED QUALIFICATIONS**:- Medical Device Regulatory Knowledge, ISO 13485, 21 CFR Part 820, ISO 14971- Experience in risk management (Risk Assessment / FMEA) - ISO 14971- Proficiency in English is desirable for this position.- Strong analytical skills with the ability to reason and influence at all levels in the value stream process