Quality Engineer

Job Description:

Creation of Validation protocols/reports and Validation Master plan

· Usage of current documentation from US for preparation of local documents

· Support of calibration systems (introduction of new, recalibration current gauges and excluding non-functional

gauges.

· Support detailed investigations of non-conforming product and customer inquiries, determine root causes, and

monitor the effectiveness of implemented corrective actions.

· Supports the QMS Manager with the collection and analysis of data and Internal and External Quality Key Indicators

(Customer Complaints, Internal Rejections, Internal Audits, Training, etc.) to determine the need to create new

Corrective and/or Preventive Actions.

· Assist in implementing quality and regulatory requirements (e.g., FDA, ISO 13485, QSR, cGMP), and ensure

compliance with testing SOPs and specifications Drive continuous improvement initiatives through direct reports and

by participating in cross-functional continuous improvement initiatives.

· Support preparation, review and revise, as required, DC-MP, SOPs, WI and specifications.

· Support preparation, monthly KPI reports and distributes them both internally and externally as needed.

· Performs other related duties as requested or assigned.

Job Requirements:

· Secondary mechanical, chemical or electrical engineering school

· Bachelor’s degree in Technical, Chemistry, Science or QMS preferred with 2-3 years of Quality experience

· Experience with creation of validation documentation.

· Compliance with medical devices

· Quality improvement

· Experience with calibration system.

Operating Company:

Spark

The 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.

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