Quality Engineer

Pay: $29/Hour on W2


Description:
• Actively partner with Manufacturing departments, providing tactical Quality support to the teams
• Investigate, analyze and correct non-conformances (internal, external and systemic issues)
• Lead root cause analysis, implement/provide corrective actions and ensure their effectiveness
• Collect, analyze, and present Quality data
• Create quality documents aligned to regulations and practices, revise quality documentation to better define, improve, or clarify practices, process and/or product quality
• Participate in change control activities for documents and manufacturing processes
• Support eDMS system with processing document change requests related to Quality System documents
• Laboratory experiments, as required
• Other duties may be assigned, as required
• Travel requirement: 0-10%



QUALIFICATIONS AND EDUCATION REQUIREMENTS
• 1+ year experience in a Quality Engineering position - familiarity with and execution of principles within Certified Quality Engineer (ASQ CQE) Body of Knowledge
• BS Biology, Chemistry, or Engineering (Chemical, Biomedical, Industrial, Mechanical or Quality) or demonstrated equivalent work experience in the Quality Engineering area pertaining to a scientific industry
• Knowledge in standards such as ISO 13485:2016 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes, ISO 9001:2015 - Quality Management Systems, and ISO 14971 Medical Devices - Risk Management.



PREFERRED SKILLS
• Knowledge of Operations and manufacturing processes
• Scientific laboratory experience highly desired
• Familiarity with enterprise software systems including ERPs, electronic document control systems, CAPA and training software packages
• Able to motivate and positively influence peers
• Ability to read, analyze, and interpret common scientific and technical data and QMS standards
• Ability to resolve rapidly common inquiries or complaints from internal and/or external customers and regulatory agencies
• Ability to effectively present information to groups of employees, site leadership, and customers
• Ability to define problems, collect data, establish facts, and draw valid conclusions