Quality Engineer

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 PURPOSE

Provides technical support and guidance to the organization through active involvement in equipment/ test metrology, statistical analysis, process/product validation and process/product development activities

II. KEY ACCOUNTABILITIES

Duties/Responsibilities:

• Adhere to all company policies and to act as a role model in the adherence to policies application/interpretation and customer expectations
• Assist in the quality system training for new employees. Also provide support to other departments for training on changes
• Develop and analyze production and statistical data to assure processes yield expected quality levels and to identify opportunities for improvements within the operation
• Develop and implement statistical sampling plans
• Develop qualification/validation plans and coordinate product/process validations
• Monitor quality metrics and progress towards goals and objectives. Identify trends and opportunities for improvement
• Perform and document customer complaint investigations.
• Perform supplier audits as required to assure consistency of supplied products and work with suppliers to resolve quality issues
• 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 requirements, CFR 820 regulations, Micron Quality System requirements, auditing, statistical process control
• Set up inspection/metrology equipment and Incoming Inspection processes. Verify the effectiveness of quality testing and inspection activities
• Support 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 QUALIFICATIONS

• Bachelor 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