Senior Quality Systems Engineer - Medical Device - Lowell

Lowell Permanent USD105,000 - USD115,000 per year
  • Work on complex, class III medical devices that are internationally recognized
  • This is a high visibility role, giving you exposure to the Sr Director of QA

About Our Client

Our client is a complex class III OEM that has nationally-recognized, life saving products. Their life-saving products are made to the highest degree, so that every product exceeds expectations.

Job Description

The Senior Quality Systems Engineer will...

  • Maintains and improves QMS
  • Recommends and implements potential improvements or enhancements to quality systems and processes
  • Leads the Quality Audit system by managing the audit schedule and participating in and leading internal audits
  • Leads Quality aspects of the Supplier Management process
  • Supports external and internal audits
  • Develops Quality Metrics, and coordinates quality data collection and analyses for Management Reviews
  • Manage CAPA
  • Maintains SOP Training for the Company; ensures employees are assigned appropriate training plans
  • Ensures compliance of QMS through SOP updates and training
  • Identifies product and process improvements; leads and supports their implementation

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 Systems Engineer will have...

  • Project management experience
  • Thorough knowledge and understanding of FDA QSR, ISO 13485 regulations
  • Experience in medical device manufacturing and EtO sterilization of disposable medical devices
  • Experience with Quality Auditing to 21 CFR Part 820 and ISO 3485.
  • Excellent track record trouble-shooting and applying effective, systematic problem-solving methodologies
  • Ability to communicate ideas and information clearly, effectively and concisely
  • Six sigma training/certification is a plus
  • Experience creating and working with databases, queries and reports is a plus

What's on Offer

The selected Senior Quality Systems Engineer will recieve...

  • Competetive compensation package
  • Hybrid work model
  • Work on state-of-the-art class III medical devices used in hospitals nation-wide
  • Work on nationally-recognized products

All qualified candidates can expect feedback within 48 hours. Please reach out to Cameron Cyker for more information.

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