Product Quality Engineer

Job Summary :

The Product Quality Engineer will be responsible for product quality engineering / quality assurance activities. This includes interpretation and implementation of quality standards to routine manufacturing, continuous improvement, and product release activities.

Essential Duties and Responsibilities :

• Develop and maintain strong internal working relationships across Conformis.
• Understand the objectives, responsibilities, and mission of the Quality department and work towards those goals.
• Prioritize and plan work activities; adapt for changing conditions.
• Perform quality testing of CER and Purified water system.
• Perform product release activities (on an as needed basis).
• Administers the bioburden / endotoxin testing program as required per procedure.
• Trend in-process manufacturing data and environmental monitoring data and produce summary reports.
• Implement and maintain quality system in accordance to applicable regulatory requirements.
• Initiate and participate in resolution of non-conforming materials.
• Review Non-Conformity Reports for sub-assemblies and finished goods.
• Administer the calibration system.
• Review of the daily activities for production start-up.
• Develop and upgrade procedures for continuous improvement as required by the quality system.
• Perform Internal Quality Audits of the quality system.
• Develop qualification / validation plans.
• Conduct product / process validations (sterilization).
• Develop and implement statistical sampling plans.
• Assist in the investigation of product complaints.
• Assist in corrective action investigations.
• Perform internal audits to drive continuous improvement (minimum of 2 per year).
• Other responsibilities as assigned.

Qualifications :

Skills, Abilities, Competencies Required :

Conformis is an Equal Opportunity Employer