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Product Quality Engineer

1 month ago

Wilmington, United States ConforMIS Full time
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