Sr Quality Engineer Seahorse Bioscience
Department: ConsumablesType: Full TimeMin. Experience: Mid Level
This position may include the supervision of QC personnel. The key components would be to conduct root cause analysis, work with production to develop product and inspection requirements. Conduct CAPA, MRR and Complaint reviews. Use statistical tools to drive decisions and conduct internal as well as vendor audits.
Responsible for conducting CAPA investigation, containment corrective/preventive action, and verification of effectiveness.
Prepare CAPA to be presented to MRB for review and approval at each stage of process.
Mentor CAPA Owners and CAPA investigators in developing investigation plan and documenting each step of process.
Develop product inspections and test procedures.
Assist quality and production department in evaluating quality issues.
Help to identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of molded products to meet or exceed internal and external requirements.
Acts as an effective team member in supporting quality disciplines, decisions, and practices.
Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.
Conduct internal as well as customer audits to ensure consistency between Seahorse and vendors.
Work with the quality group to ensure all calibrations are completed in a timely manner.
Assist quality and production department in evaluating quality issues using statistical and problem solving techniques to determine root cause, implement corrective and preventive actions to improve processes.
Investigate customer quality complaints/returns and provide feedback to customers.
Participate in studies to identify process capabilities, develop product inspection and test procedures, and report quality requirements.
BS in Engineering or technical field preferred.
5+ years experience with Plastic Molding(Injection/Extrusion)
Strong written/verbal communication skills.
Demonstrated use of Quality tools/methodologies.
5+ years experience with capa, corrective action and writing procedures
Working knowledge of Quality Systems and related requirements and standards, including ISO 13485.
||Chicopee, MA |