MICRON PRODUCTS
Quality Systems Engineer
MICRON PRODUCTS, Fitchburg, Massachusetts, United States,
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.
JOB PURPOSE
The Sr. Quality Systems Engineer is responsible for supporting the Quality System by coordinating document change activities and monitoring compliance to ISO13483 and CFR 820 quality assurance requirements.
KEY ACCOUNTABILITIES
Duties/Responsibilities:
Oversee daily document control activitiesActively participate in the Internal Auditing program as a primary internal auditorAdhere to all company policies and to act as a role model in the adherence to policiesAssist in the quality system training for new employees. Also provide support to other departments for training on changes. Including but not limited to Coordinate document change activity. Process changes to prints, procedures and forms in accordance with established practices and standards.Assure all document control changes are properly communicated, distributed, and controlledCollaborating with associated departments in support of process improvement/enhancement activities.Compile certification documents, perform final packaging/labeling audit and release product for shipmentLiaison with regulatory reporting agencies and environmental consultantsMonitoring applicable quality systems through trending analysis, compiling metrics and developing reports on a regular basis. Such as Management review, CAPAs, SCARs, non-conformanceSupport the corrective and preventive action process by conduction root cause analysis, assisting in action plan creation, assisting in implementing of action plan and performing verification of effectiveness.Perform and document customer complaint investigations. Assist Quality department
with findings to assure actions are effectiveProvide 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, CFR 820 standards, Micron Quality System requirements, auditing, statistical process control
JOB QUALIFICATIONSHigh School diploma is required. Two year technical degree is preferredAbility to read and interpret engineering drawings is requiredISO 13485, CFR 820 experience preferred.Must be able to read, write and speak English fluentlyMust be capable of developing procedures, work instructions, flow charts and forms in support of the quality system requirementsStrong facilitation /communication / training skills are strongly recommendedProficiency in the use of computers, specifically the programs associated with Microsoft Office, is requiredPM21
PI7c1c01808f3d-37448-35619005
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.
JOB PURPOSE
The Sr. Quality Systems Engineer is responsible for supporting the Quality System by coordinating document change activities and monitoring compliance to ISO13483 and CFR 820 quality assurance requirements.
KEY ACCOUNTABILITIES
Duties/Responsibilities:
Oversee daily document control activitiesActively participate in the Internal Auditing program as a primary internal auditorAdhere to all company policies and to act as a role model in the adherence to policiesAssist in the quality system training for new employees. Also provide support to other departments for training on changes. Including but not limited to Coordinate document change activity. Process changes to prints, procedures and forms in accordance with established practices and standards.Assure all document control changes are properly communicated, distributed, and controlledCollaborating with associated departments in support of process improvement/enhancement activities.Compile certification documents, perform final packaging/labeling audit and release product for shipmentLiaison with regulatory reporting agencies and environmental consultantsMonitoring applicable quality systems through trending analysis, compiling metrics and developing reports on a regular basis. Such as Management review, CAPAs, SCARs, non-conformanceSupport the corrective and preventive action process by conduction root cause analysis, assisting in action plan creation, assisting in implementing of action plan and performing verification of effectiveness.Perform and document customer complaint investigations. Assist Quality department
with findings to assure actions are effectiveProvide 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, CFR 820 standards, Micron Quality System requirements, auditing, statistical process control
JOB QUALIFICATIONSHigh School diploma is required. Two year technical degree is preferredAbility to read and interpret engineering drawings is requiredISO 13485, CFR 820 experience preferred.Must be able to read, write and speak English fluentlyMust be capable of developing procedures, work instructions, flow charts and forms in support of the quality system requirementsStrong facilitation /communication / training skills are strongly recommendedProficiency in the use of computers, specifically the programs associated with Microsoft Office, is requiredPM21
PI7c1c01808f3d-37448-35619005