Bachelor's degree in Engineering or Science required.
1-3 years of experience in Quality Assurance/Quality Engineering preferred, ideally in FDA regulated settings.
Familiarity with QSR (21 CFR Part 820) is a plus.
Strong understanding of FDA and ISO standards for Medical Devices is advantageous.
Proficiency in Microsoft Office 2010 is required.
Responsibilities
Develop and maintain internal relationships across the organization.
Understand and align with the Quality department's goals.
Prioritize and manage work activities effectively under changing conditions.
Conduct quality testing of CER and Purified water systems.
Administer and manage the bioburden/endotoxin testing program when needed.
Trend and summarize in-process manufacturing and environmental monitoring data.
Implement and maintain the quality system complying with regulatory requirements.
Benefits
Opportunities for continuous learning and professional development.
Collaborative work environment across teams and departments.
Engagement in meaningful product quality initiatives.
Participation in internal audits and continuous improvement projects.
Full Job Description
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.
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.
