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Product Quality Assurance Specialist
1 month ago
The Product Quality Engineer will be responsible for ensuring the quality and reliability of our medical devices. This includes interpreting and implementing quality standards, conducting quality testing, and developing and maintaining quality systems.
Key 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).
- Administer 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.
- 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).
- 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.
