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 
