Job Description

ROLE AND RESPONSIBILITIES

* 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, maintain and evaluate product/process trends, designing and participating in process and product improvement plans
* Ensure risk assessment activities are completed for relevant processes/products (i.e. dFMEA, pFMEA)
* Create and implement projects for quality improvement
* Responsible to approve installation qualifications (IQs) engineering studies, operation qualification (OQs) and process qualification (PQs) when designated
* Recommend product revisions, process changes, and testing procedures to assure that quality standards are being attained
* Create quality documents aligned to regulations and practices, revise quality documentation to better define, improve, or clarify practices, process and/or product quality
* Participate as internal auditor, and participate in external audits
* Participate actively in Continuous Improvement programs
* Participate in change control activities for documents and manufacturing processes
* Participate in Product Development Process assuring design quality elements are maintained and compliant with ISO 13485 and applicable regulations (e.g., supply chain, design controls, verification and validation activities, review of quality control plan and product specifications)
* Laboratory experiments, as required
* Other duties may be assigned, as required
* Travel requirement: 0-10%

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

QUALIFICATIONS AND EDUCATION REQUIREMENTS

* 1+ year experience in a Quality Engineering position highly desired familiarity with and execution of principles within Certified Quality Engineer (ASQ CQE) Body of Knowledge
* Associates required. BS in Chemistry, Biology, or Engineering (Chemical, Biomedical, Industrial, Mechanical or Quality) preferred. 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.