Supplier Quality Engineer - Medical Device - Concord NH

Concord Permanent USD80,000 - USD95,000
  • Work on a wide variety of products in the medical device industry end-to-end
  • Leading manufacturer of medical-device components used by top organizations

About Our Client

Our client is an ISO 13485 certified medical device component manufacturer that provides end-to-end solutions for their clients. They take their customer's specifications and run them from initial design stages through packaging. Through attention to detail and a dedicated team, our client is one of the most trusted medical device manufacturers for big name distributors.

Job Description

Essential duties and responsibilities for the Sr. Quality Engineer:

  • Maintain company compliance with FDA Quality System Regulations and ISO 13485 standards.
  • Actively participates in internal audits, management review and other activities covered under Quality Manual, Policies and Procedures
  • Provide customer related quality and regulatory inquiries support
  • Compiles and writes training material and conducts training sessions on quality control activities
  • Provide QE direction, analysis and recommendations for Product Development to successfully launch new products into active production in a timely and cost effective manner. Directs development and maintenance of internal/external standards relative to Design and Development,
  • Develops and initiates standard methods for inspection, testing, and evaluation, utilizing knowledge in related engineering fields
  • Devises sampling procedures and designs and develops forms and instructions for recording, evaluating, and reporting quality and reliability data
  • Performs measurement system analyses to evaluate test and inspection equipment
  • Leads disposition of discrepant material and devises process to assess product quality and reliability
  • Monitors and directs engineering group on calibration requirements and implementation of systems to support equipment calibration
  • Lead supplier approval and qualification of new/revised items which includes inspection method development and validation as well as correlation with supplier's methods, supplier audits, management of supplier corrective and preventative actions and assist in FMEA
  • Demonstrates leadership through mentoring of junior staff and responsiveness to business needs to achieve positive results

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

Qualifications for the Sr. Quality Engineer:

  • 3-8 years experience in the Medical Device or other regulated industry, such as QSR and ISO 13485
  • Experience with FDA and ISO 13485 Certification inspection
  • Must be adept in use of computer software for the analysis of data, preferably Microsoft Excel and statistical packages (Minitab preferred)
  • Quality Engineering certification (CQE) preferred or equivalent body of knowledge in areas which include, but are not limited to Statistics, SPC, Geometric Dimensioning/Tolerancing; Sampling, Design of Experiments, etc. Ability to analyze, understand and effectively communicate this technical material. Experience with Lean Manufacturing and Six Sigma is a plus
  • Ability to organize and judge priorities in a dynamic, fast-paced environment and work independently with minimal supervision

What's on Offer

Our client is offering the Sr Quality Engineer:

  • Competitive Salary and Bonus Potential
  • Upwards Mobility
  • Comprehensive Medical Plan Options
  • Vision/Dental Plan
  • 401(k) Savings Plan
  • Life Insurance Plan
  • Vacation and Holiday Pay
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
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