Quality Systems Manager

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 ISO13483 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

• 10+ year of similar work experience,
• Bachelor of Science degree preferred.
• Ability to read and interpret engineering drawings is required
• Detailed understanding of regulatory and compliance protocols for ISO 13485, and cGMP 21 CFR part 820
• 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
• Experience with IQMS ERP is a plus

PM21