Quality Systems Engineer

6 days ago

San Francisco, California, United States MICRON PRODUCTS Full time
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 Responsibilities
  1. Support the Quality System by coordinating document change activities and monitoring compliance to ISO13485 and CFR 820 quality assurance requirements.

The Senior Quality Systems Engineer is responsible for overseeing daily document control activities, actively participating in the Internal Auditing program as a primary internal auditor, and adhering to all company policies. They will also assist in the quality system training for new employees and provide support to other departments for training on changes.


  • Oversee daily document control activities.
  • Actively participate in the Internal Auditing program as a primary internal auditor.
  • Adhere to all company policies and to act as a role model in the adherence to policies.
  • Assist in the quality system training for new employees.
  • Provide support to other departments for training on changes.
  • Collaborate with associated departments in support of process improvement/enhancement activities.
  • Compile certification documents, perform final packaging/labeling audit and release product for shipment.
  • Liaison with regulatory reporting agencies and environmental consultants.
  • Monitor applicable quality systems through trending analysis, compiling metrics and developing reports on a regular basis.
  • Support the corrective and preventive action process by conducting 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.
  • Provide support to manufacturing, project and product development activities.
  • Review results and provide recommendations for changes/improvement.
  • Provide training support in the areas of all ISO 13485, CFR 820 standards, Micron Quality System requirements, auditing, statistical process control.

Job Qualifications
  • High School diploma is required. Two year technical degree is preferred.
  • Ability to read and interpret engineering drawings is required.
  • ISO 13485, CFR 820 experience preferred.
  • Must be able to read, write and speak English fluently.
  • Must be capable of developing procedures, work instructions, flow charts and forms in support of the quality system requirements.
  • Strong facilitation/communication/training skills are strongly recommended.
  • Proficiency in the use of computers, specifically the programs associated with Microsoft Office, is required.

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