Job Description: SUMMARY: The Process Engineer is responsible to assure that all digital process for treatment planning are aligned with the Quality management system. It is charged with 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 processes 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 peers 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 PackageProficient in using Electronic Document Management SystemsExperience in designing, execution, and measurement of quality processesExperience in investigation methodology and root cause analysis (5 Why's, Fishbone etc.)Experience in statistical analysis methodology / data analysisExcellent Verbal and Written Skills (English), and interpersonal skillsPREFERRED QUALIFICATIONS: Medical Device Regulatory Knowledge, ISO 13485, 21 CFR Part 820, ISO 14971Experience in risk management (Risk Assessment / FMEA) - ISO 14971Proficiency 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.Lean Manufacturing knowledge for process mapping, analysis and improvement.CERTIFICATIONS: Bachelor's degree or internationally equivalent in Industrial Engineering, Quality engineering or other related fieldsTypically has 2 - 3 years of directly related experienceTableau KnowledgeLEAN SIX SIGMA GREEN BELT PREFERRED QUALIFICATIONSThe Spark Clear Aligner System is manufactured by Ormco, a global leader in innovative orthodontics products. Spark aligners are made with TruGEN, the latest innovation in clear aligner material. In the same way that Spark is designed to give orthodontists more control and flexibility, our careers are designed to give you more control and flexibility. Working at the intersection of technology and patient needs, you'll be positioned to drive disruptive thinking and spark your career.
#J-18808-Ljbffr