MICRON PRODUCTS
Quality Engineer
MICRON PRODUCTS, Coeur D Alene, Idaho, United States, 83814
Job Details
Job Location:
fitchburg, MA
Micron Solutions is a multifaceted contract manufacturing organization specializing in thermoplastic injection molding, precision machining and finishing, and silver-plated medical sensors for disposable electrodes. We work with clients of all sizes to provide manufacturing solutions and assembly services to help our customers meet their goals. Our 120,000 square foot Fitchburg, MA manufacturing facility is capable of serving customers’ projects from concept to commercialization.I.
JOB PURPOSEProvides technical support and guidance to the organization through active involvement in equipment/ test metrology, statistical analysis, process/product validation and process/product development activitiesII.
KEY ACCOUNTABILITIESDuties/Responsibilities:Adhere to all company policies and to act as a role model in the adherence to policies application/interpretation and customer expectationsAssist in the quality system training for new employees. Also provide support to other departments for training on changesDevelop and analyze production and statistical data to assure processes yield expected quality levels and to identify opportunities for improvements within the operationDevelop and implement statistical sampling plansDevelop qualification/validation plans and coordinate product/process validationsMonitor quality metrics and progress towards goals and objectives. Identify trends and opportunities for improvementPerform and document customer complaint investigations.Perform supplier audits as required to assure consistency of supplied products and work with suppliers to resolve quality issuesProvide support to manufacturing, project and product development activities. Review results and provide recommendations for changes/improvementProvide training support in the areas of all ISO 13485 requirements, CFR 820 regulations, Micron Quality System requirements, auditing, statistical process controlSet up inspection/metrology equipment and Incoming Inspection processes. Verify the effectiveness of quality testing and inspection activitiesSupport the corrective and preventive action process by conduction root cause analysis, assisting in action plan creation, assisting in implementing of action plan as required and performing verification of effectiveness.Provides internal and external audit support
III.
JOB QUALIFICATIONSBachelor of Science in Engineering or Science or a minimum of 10 years in a Quality Assurance position required. CQE (Certified Quality Engineer) a plus.Experience with SPC and MRP software a plus.Medical Device development and manufacturing experience.Must have experience in the areas of metrology, auditing, and statistical analysis. ISO 13485, and CFR 820 experience preferred.Must possess computer application skills – primarily MS Office. Strong facilitation and communication (written and verbal) skills required.Validation experience preferred.Strong organizational skills needed. Ability to work independently and strong process control background.PM21
PI5375ac15037e-35216-35699297
Job Location:
fitchburg, MA
Micron Solutions is a multifaceted contract manufacturing organization specializing in thermoplastic injection molding, precision machining and finishing, and silver-plated medical sensors for disposable electrodes. We work with clients of all sizes to provide manufacturing solutions and assembly services to help our customers meet their goals. Our 120,000 square foot Fitchburg, MA manufacturing facility is capable of serving customers’ projects from concept to commercialization.I.
JOB PURPOSEProvides technical support and guidance to the organization through active involvement in equipment/ test metrology, statistical analysis, process/product validation and process/product development activitiesII.
KEY ACCOUNTABILITIESDuties/Responsibilities:Adhere to all company policies and to act as a role model in the adherence to policies application/interpretation and customer expectationsAssist in the quality system training for new employees. Also provide support to other departments for training on changesDevelop and analyze production and statistical data to assure processes yield expected quality levels and to identify opportunities for improvements within the operationDevelop and implement statistical sampling plansDevelop qualification/validation plans and coordinate product/process validationsMonitor quality metrics and progress towards goals and objectives. Identify trends and opportunities for improvementPerform and document customer complaint investigations.Perform supplier audits as required to assure consistency of supplied products and work with suppliers to resolve quality issuesProvide support to manufacturing, project and product development activities. Review results and provide recommendations for changes/improvementProvide training support in the areas of all ISO 13485 requirements, CFR 820 regulations, Micron Quality System requirements, auditing, statistical process controlSet up inspection/metrology equipment and Incoming Inspection processes. Verify the effectiveness of quality testing and inspection activitiesSupport the corrective and preventive action process by conduction root cause analysis, assisting in action plan creation, assisting in implementing of action plan as required and performing verification of effectiveness.Provides internal and external audit support
III.
JOB QUALIFICATIONSBachelor of Science in Engineering or Science or a minimum of 10 years in a Quality Assurance position required. CQE (Certified Quality Engineer) a plus.Experience with SPC and MRP software a plus.Medical Device development and manufacturing experience.Must have experience in the areas of metrology, auditing, and statistical analysis. ISO 13485, and CFR 820 experience preferred.Must possess computer application skills – primarily MS Office. Strong facilitation and communication (written and verbal) skills required.Validation experience preferred.Strong organizational skills needed. Ability to work independently and strong process control background.PM21
PI5375ac15037e-35216-35699297