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Quality Engineer

  • LocationDover, NH 03820 - United States
  • Work TypeFull time
  • Positions1 Position
  • Published At:2 months ago
  • Job no: 39091
  • Category: Maintenance/Engineering

Job Description

Our client, a leading medical device company, is looking for a Quality Engineer to join their team. If you have the required experience and are up for a challenge, this could be a great opportunity for you. Responsibilities include:

1) Develop, document and implement QA procedures

2) Interpret and assess conformity to appropriate regulatory standards

3) Analyze non-conforming materials and returned goods and recommend disposition and corrective actions

4) Create suitable data analysis tables and report findings based on statistical evidence and trending

5) Provide analytical investigations and develop root cause for non-conformances and deviations

6) Design and specify gauging and test equipment for quality assurance functions

7) Write protocols, analyze data and generate summary reports for verifications and validations

8) Lead and participate in design control projects for new and changing medical devices

9) Interface with vendors and customers, as required

10) Review documentation for completeness and accuracy

11) Complete lot history and sterility reviews for production records

12) Complete other tasks as assigned by quality leadership

13) Collaborate with Quality, Production Engineering and Manufacturing teams to establish quality standards for new and existing products

14) Participate in design and risk management reviews, pFMEA, validations, CAPAs and NCMRs

15) Conduct supplier evaluations, qualifications and quality audits

16) Support registration, certification and demonstrate controls for manufacture

17) Ensure the content of design history file meets regulatory and company requirements including the maintenance of risk management files

18) Support the process qualification and verification

19) Perform other duties as assigned

Critical Requirements

1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the medical device industry is strongly preferred

4) Preference will be given to candidates with recent experience in quality engineering

This role is ideal for a qualified, energetic individual who possesses great attention to detail. So, if you’re looking for a rare and exciting opportunity in quality engineering and want to do it within a quality company, this could be the perfect role for you - please apply ASAP!

Compensation and Other Details

Base Salary: Highly competitive package, commensurate with experience


  • Published on 12 Oct 2021, 12:53 PM