Quality Engineer - Cardiovascular Technology - Rochester NH

Rochester Permanent USD75,000 - USD80,000
  • Become a key member of the quality team for a global medical device manufacturer
  • Work on complex class III medical devices, furthering your industry career

About Our Client

Our client is a leader in Cardiovascular Medical Technology. With a trusted global network, they are a name brand in their industry.

Job Description

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.

Description

The Quality Engineer will ...

  • Interprets and assesses conformity to appropriate regulatory standards.
  • Analyzes non-conforming materials and returned goods and recommend disposition and corrective actions.
  • Creates suitable data analysis tables and report findings based on statistical evidence and trending.
  • Provides analytical investigations and develop root cause for non-conformances and deviations.
  • Writes protocols, analyzes data and generates summary reports for verifications and validations.
  • Complete lot history and sterility reviews for production records.
  • Completes other tasks as assigned by Quality leadership
  • Collaborates with quality, production engineering and manufacturing teams to establish quality standards for new and existing products.
  • Participates in design reviews, pFMEA, risk management reviews, validations, CAPA's, NCMR's, etc.
  • Conducts supplier evaluations, qualifications and quality audits.
  • Supports registration, certification and demonstrate controls for manufacture; (Facilities compliance, Clean room).
  • Assures the content of Design History File meets regulatory and company requirements including the maintenance of risk management files.

The Successful Applicant

All qualified Quality Engineers should have the following...

  • BS or MS in Engineering, or scientific disciple with experience in the manufacture of medical devices/disposables (Class II) for the medical device market.
  • Certified Quality Engineer or Quality Auditor (ASQ) - preferred.
  • Experience with Design Control, Process Validation, Failure Investigations, Root Cause Analysis and the application of statistics to the practice of Quality Assurance.
  • Experience participating in FMEAs or other risk assessment activities.
  • Experience with supporting FDA & Certified Body Audits.

What's on Offer

The Quality Engineer will get in return...

  • 401k Matching
  • Tuition Reimbursement
  • Referral bonuses
  • Incentive Based Bonuses
  • Competitive Salary



Please reach out with any questions to Cameron Cyker. All Qualified applicants can expect feedback within 48 hours.

Contact
Cameron Cyker
Quote job ref
JN-122021-4558991

Job summary

Sector
Engineering & Manufacturing
Sub Sector
Six Sigma, Lean, Process improvement
Industry
Industrial / Manufacturing
Location
Rochester
Contract Type
Permanent
Consultant name
Cameron Cyker
Job Reference
JN-122021-4558991