Quality Manager

  • Viant
  • 1040 Sheridan Street, Chicopee, MA 01022, USA
  • Jul 25, 2019
Full time Management QA-Quality Control Strategy-Planning

Job Description

Viant, a leading manufacturer of medical devices, is looking for a Quality Manager to join their Chicopee, MA team. This is a critical role that will provide quality system leadership for the entire facility as well as acts as liaison to division and is responsible for managing the quality system of the facility.

Some of the benefits to you:

  • Competitive compensation
  • Benefits package (starting day 1) that includes: medical, dental, vision and 401(k) with company match (401k after 90 days)
  • Paid time off and holidays
  • Greater stability – Viant recently doubled in size and is investing heavily in their facilities

Facility Highlights:

  • 76,000 sq. ft.
  • Class 8 clean room, white room
  • 41 molding presses (3 tons – 1,000 tons) including 10 micromolding slide machines
  • ISO 13485 certified, ISO 9001

Capabilities:

  • Molding: two-shot, multicomponent, over, insert, micro, spin stack
  • Extrusion blow molding
  • Gas-assist & RJG in-process decoupled molding

Position Qualifications:

  • Bachelor’s Degree in field relating to engineering, manufacturing, or quality
  • Minimum of 5 years’ experience in a manufacturing environment, preferably related to the medical field
  • Familiarity with ISO and FDA Regulations
  • Skilled in the use of statistics and root cause analysis as they relate to production
  • Excellent communications and organizational skills
  • Able to manage multiple priorities with many time constraints
  • Excellent computer skills, utilizing word processing, spreadsheets, project software and statistical software as well as job control software

Please click Apply or email your information to: viant17@workrocket.com

Responsibilities:

  • Responsible for compliance to 21 CFR 820, ISO 13485, Quality Manual and companywide policies
  • Final authority to reject or accept product
  • Responsible for creating and delegating new employee training into the quality system as well as annual training for all existing employees
  • Review operation processes and verify that proper gaging methods and proper frequencies are on inspection sheets
  • Management of Document Control to maintain Quality System Documentation, Device Master Record, Document Control, Request for Change, and External Standards
  • Management of Gage Calibration system
  • Support implementation and continuous improvement of processes through SOP’s, CAPA, supplier auditing and Management Reviews
  • Administer effective internal audits of the Quality System
  • Maintain customer complaint log, documenting returns and corrective actions to returns
  • Run quality department with employees who are trained to perform their assignments in a professional and timely manner.
  • Reduce variation in gaging processes by implementing and monitoring most recent technologies in gaging
  • Automate inspection methods where possible to reduce manual inspections
  • Maintain corrective action system and review effectiveness and implementation of corrective actions

About the company: With over 35 years of medical device molding experience, Viant has become a comprehensive solutions provider for single use medical devices. Services range from concept and design of components to assembly of finished products. They are headquartered in Foxborough, MA and operate 17 manufacturing facilities in the US, with additional locations in China, Mexico, Costa Rica, Puerto Rico, France, Germany and the UK.

All qualified applicants will receive consideration for employment without regard to the individual's race, color, sex, national origin, religion, age, disability, genetic information, status as a military veteran or any other characteristic protected by applicable law.