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:

• Bachelor of Science in Engineering or Science.
• 1-3 years of Quality Assurance/Quality Engineering and experience in a FDA regulated environment is preferred – with QSR (21 CFR Part 820) experience if possible (Job Specific Qualifications).

Skills, Abilities, Competencies Required:

• Excellent written and verbal communication skills.
• Able to work accurately in a fast-paced, hectic, ever-changing environment with strong attention to detail.
• Demonstrated ability to monitor own work to ensure quality, accuracy, and thoroughness.
• Strong organizational, analytical, and time-management skills.
• Able to self-motivate and work both independently and as part of a team.
• Must have a solid knowledge of Microsoft office 2010.
• Knowledge of FDA and ISO standards for Medical Devices is a plus.
• Knowledge of Statgraphics or Minitab is a plus.

Conformis is an Equal Opportunity Employer