Senior Quality Engineer - Medical Device - Chicopee MA

Chicopee Permanent USD85,000 - USD105,000
  • Hands on Quality Engineering Position with Industry Leader in Skin-Contact Tech
  • Established ISO 13485 certified manufacturer offers ample growth potential

About Our Client

For over 50+ years, our client has been the leader in the development of Swab technologies for the Medical and Aerospace industries. You will find their products in COVID testing kits, skin protectants, pre-surgery kits, aerospace manufacturing, and many other places.

Job Description

The Quality Engineer will be responsible for:

  • Work closely with Engineering, Operations, and QC to ensure quality performance of products and processes.
  • Participate in the development and improvement of the manufacturing processes for existing and new products.
  • Perform and document root cause investigations for internal and external rejections.
  • Generate, review, and maintain quality records.
  • Develop an understanding of change and risk management practices and concepts with the ability to become proficient in process risk.
  • Assist in the development, execution, and review of process and equipment validation with the ability to become proficient in validation processes.
  • Analyze data, to determine trends, as part of continuous improvement activities.
  • Assist with the notified body and regulatory authority audits and inspections.
  • Execute internal audits.
  • Maintain calibration activities as applicable.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

The Requirements for the Quality Engineer are:

  • Bachelor's Degree in a related field or
  • 3+ years of Quality experience in a regulated environment.
  • Working knowledge of quality assurance principles.
  • Knowledge of FDA/cGMP and ISO 13485 regulations/guidelines.
  • Solid problem solving skills

What's on Offer

The Quality Engineer will get in return:

  • Competitive Compensation and Bonus Structure
  • Employer-matching 401(k)
  • Medical/Dental/Vision insurance
  • Employer-paid short-term disability insurance
  • Employer-paid long-term disability insurance with a voluntary option
  • Employer-paid basic life insurance with a voluntary option
  • Paid vacation time/sick days/holidays
Cameron Cyker
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Job summary

Engineering & Manufacturing
Sub Sector
Six Sigma, Lean, Process improvement
Industrial / Manufacturing
Contract Type
Consultant name
Cameron Cyker
Job Reference