Overview
Quality Systems Manager Jobs in Fitchburg, Massachusetts, USA at MICRON PRODUCTS
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.
I. JOB PURPOSE
The Quality Manager is responsible for supporting the Quality System by coordinating document change activities and monitoring compliance to ISO
13483 and CFR 820 quality assurance requirements.
II. 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
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
Coordinate document change activity. Process changes to prints, procedures and forms in accordance with established practices and standards.
Liaison with regulatory reporting agencies and environmental consultants
Monitoring applicable quality systems through trending analysis, compiling metrics and developing reports on a regular basis. Trending/reporting of quality data
Perform and document customer complaint investigations. Assist Quality Manager with findings to assure actions are effective
Provide support to manufacturing, project and product development activities.
Create baseline pFMEA, Validation plans/protocols, DMRs and review it with engineers, and send it to customer for feedback.
Act as a gatekeeper between engineering, and operations for new product introduction ensuring compliance to Micron’s processes.
Provide training support in the areas of all ISO 13485, CFR 820 standards, Micron Quality System requirements, auditing, statistical process control
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 Vendor Onboarding, and Periodic Assessment for Critical Materials,
Onboarding:
Assess vendor’s QMS system and assess the capability of vendor to produce the material/component in discussion alongside with Engineers as part of onboarding.
Periodic Assessment:
Calculate Vendor Ratings and reach out to suppliers who don’t meet the performance requirements. Issue SCARs as needed, and follow-up on the actions required.
Sustaining:
Lead and drive Supplier corrective action (SCARs) on process and product related quality issues. Follow-up on supplier corrective action, evaluate responses and ensure objective evidence substantiates adequate closure.
III. 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
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Title: Quality Systems Manager
Company: MICRON PRODUCTS
Location: Fitchburg, Massachusetts, USA
Category: Quality Assurance – QA/QC, Manufacturing / Production
