Job Description

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.

1. 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.

1. KEY ACCOUNTABILITIES

Duties/Responsibilities:

• 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. 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 controlled
• Collaborating 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
• Monitoring applicable quality systems through trending analysis, compiling metrics and developing reports on a regular basis. Such as Management review, CAPAs, SCARs, non-conformance
• Support 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 effective
• 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

PM21

PI16b0acabfa8e-30492-35619005

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