What are the responsibilities and job description for the Quality Engineer position at Fusion Life Sciences Technologies LLC?
Job Description & Duties:
· The Quality Engineer is responsible for supporting the sites’ test lab for production.
· Apply quality and statistical principles in order to maintain safety and quality systems within laboratory and site operations, including writing standard operating procedures (SOPs) and test procedures, data sheets documents.
· Provide oversite for Calibration program.
· The Quality Engineer plays a crucial role in conducting customer-specific tests, generating test data reports, and collaborating with the Technical Support Department to ensure timely and accurate responses to inquiries related to laboratory tests
This position involves working closely with engineering to enhance lab equipment and providing essential testing support for new product releases
Ensure the effective operation and maintenance of all laboratory equipment, adhering to regulatory requirements
Develop and maintain standard operating procedures to comply with regulatory and AS9100 requirements
Evaluate new equipment and raw materials for safety compliance
Oversee procurement of supplies and preventive maintenance of facility equipment
Provide technical assistance via various communication channels
Complete technical product reports and reports on encountered product problems
Facilitate open and effective communication between cross functional teams.
Handling and testing of samples requiring adherence to OSHA and safety policies
Address requests from management in a timely manner
Conduct quality and safety audits as required
Mandatory Qualifications:
Bachelors of Science (Engineering Preferred)
5 – 10 years’ experience in quality/manufacturing/process engineering
Previous experience in quality/process engineering function in manufacturing environment and proficient in ERP, Laboratory Management software, quality systems, and Management of Change
Continuous improvement background with demonstrated experience in problem solving and root cause analysis
Knowledge of statistical methods, standards, and execution of standards
Knowledge of quality systems, ISO9001/AS9100 requirements
Experience in material/analytical testing
Understanding manufacturing processes and value chain
Preferred Qualifications:
Six Sigma Black Belt certification (preferred)
