Quality Systems Manager Job at MICRON PRODUCTS, Fitchburg, MA

bnh4dVJmTWYrdG5LU1JyL2xIb2g0ajF6
  • MICRON PRODUCTS
  • Fitchburg, MA

Job Description


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 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

  • 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

PIac6b5f00c227-30492-36445470

Job Tags

Contract work,

Similar Jobs

VCA Green

Energy Modeler Job at VCA Green

 ...California Energy Code and/or ASHRAE 90.1. Capacity or willingness to learn about HVAC systems, such as heat pumps, and cooling towers. Ability to provide information on energy efficiency measures based on modeling outputs to a project manager. Ability to communicate... 

Yeshiva University

Science for Non-majors Adjunct instructor, Katz Associate Degree Programs | Yeshiva University Job at Yeshiva University

 ...Science for Non-majors Adjunct instructor, Katz Associate Degree Programs Job No: 497810 Work Type: Faculty Part-time Department: Mordecai and Monique...  ...Washington Heights: Human Genetics Biology & Public Health Scientific Literacy for Responsible... 

CrossCountry Freight Solutions

Class A Truck Driver (7am Start) Job at CrossCountry Freight Solutions

CrossCountry Freight Solutions is hiring a Class A Route Delivery Driver. We are looking for qualified applicants who have a safety-first...  ...- Friday (7am-6pm) Pay: $29.50/hr Benefits and More: Local, Home Daily = No Over the Road Dedicated Routes + Consistent... 

Marriott

Security Engineer - HashiCorp Vault Job at Marriott

 ...VIEW ON MAP ( Schedule Full Time Located Remotely? Y Position Type Management JOB SUMMARY We are seeking a talented HashiCorp Vault System Engineer to join our growing team. In this role, you will be responsible for managing and maintaining the HashiCorp... 

AVM Consulting Inc

Oracle PL/SQL developer Job at AVM Consulting Inc

 ...is at the forefront of leveraging data and technology to drive performance and optimize business operations. We are seeking a skilled PL...  ...Experience with UAT Experience with Unit & Integration testing Requirement gathering skills Other details ~ On-site job...