Senior Quality Engineer - Medical Device - Somerville MA

Somerville Permanent USD90,000 - USD140,000
  • Pain-free technology to aide in self-administering medication
  • Report to Senior Directors of QA/RA for high visibility and upwards mobility

About Our Client

Our client is working on revolutionizing self-administering medication through a pain-free, needle-free process. Working with top pharmaceutical organizations to ensure a safe delivery, our client is dedicated to providing a successful replacement for auto-injectors.

Job Description

The Senior Quality Engineer will:

  • Design Controls - Support Verification & Validation, test method validation, Incoming Inspection, lot release of engineering, clinical and commercial devices, nonconforming product disposition, review of design documentation, calibration and equipment validation (IQ/OQ/PQ)
  • Quality Systems - Support continuous improvement of quality system procedures in accordance with 21 CFR 820, ISO 13485, EU MDR, MDSAP, and ISO 14971
  • CAPA - Participate with other team members in all aspects of Corrective and Preventive action process as required, including documentation of CAPA, root cause investigation, and implementation of improvement activities
  • Complaint Handling - Participate in complaint processing and trending, and failure investigations as needed
  • Management Review - Assist management representative in compiling and trending Management Review metrics
  • Supplier Management - Perform vendor audits and interact with vendors surrounding Supplier Corrective Action Requests (SCAR)
  • Work with software team and support software development in compliance with IEC 62304

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 Senior Quality Engineer must have:

  • B.S. degree in Engineering, Science, or related discipline required.
  • Master's degree in engineering or MBA a plus.
  • Minimum 5 years of experience, preferably in the medical device space.
  • Strong working knowledge of 21 CFR 820, ISO 13485, and ISO 14971.
  • Knowledge and experience with MDSAP, EU MDR, IEC 62304, and ISO 60601 requirements
  • Proven track record in new product development and commercialization, post-launch experience
  • Knowledge of sterilization processes for medical devices

What's on Offer

The Senior Quality Engineer can expect:

  • Competitive compensation and benefits
  • Stock options at a lucrative startup
  • Work From Home flexibility

Please reach out to Cameron Cyker for any questions, and apply today!

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