Quality Specialist

Quality Specialist fitchburg, MA 01420 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.

I. JOB PURPOSE

The Quality Specialist is responsible for maintaining the calibration system updating databases, logs and reports as required. Performs batch record reviews assuring they're complete and accurate. Coordinates document change activities for control plans, procedures, work instructions and forms.

II. KEY ACCOUNTABILITIES

Duties/Responsibilities:

Coordinate document change activity. Process changes to prints, procedures and forms in accordance with established practices. Assure changes are properly communicated, distributed, and controlled. Manage the calibration system. Maintain logs and records. Assure that equipment is in calibration, is in proper working order and is appropriately stored to prevent damage. Actively participate in the Internal Auditing program as the primary internal auditor and as trainer / facilitator for all other internal auditors. Monitor quality system activities to assure that audits are completed on a timely basis, corrective and preventive actions are being addressed and opportunities for improvement are identified. Performs batch record review assuring batch records are complete and accurate prior to shipment to customer. Identify quality system issues immediately to manager and provide recommendation for resolution. Provide dimensional inspection back-up as needed to production departments. Assist in the quality system training for new employees. Also provide support to other departments for training on changes. Qualifications

III. JOB QUALIFICATIONS

High School Diploma or GED Ability to read and comprehend written work instructions Ability to understand verbal instructions Basic computer skills to input daily information Competent with Microsoft Office Program Familiar with

ISO 13485

standard and CFR 820 regulations General understanding of Statistical Process Control principles Ability to read and interpret prints and customer requirements Proficient with standard dimensional gages-caliper, micrometer, drop indicator, comparator