Job Details for Senior Quality Engineer

Return to Search Jobs

Matrix Recruitment Group is currently seeking a Senior Quality Engineer to be based in Wexford.

As the Senior Quality Engineer you will work for our client, a Medical Device company, in a contract  job.

As a Senior Quality Engineer you will assure that new product designs and the processes for manufacturing them meet all local, Corporate and Divisional requirements.

 

 

Key Responsibilities:

 

  • Leads the Quality engineering activities for NPD projects, supporting and participating in NPD teams.
  • Develops design and process risk management documentation with cross-functional support.
  • Support the development of device Design Inputs, Design Outputs, Product Specifications, Product Development Plans, and applicable design control documents.
  • Lead the development of the DFMEA, coordinating input from the other Design Sub-team members.
  • Executes product sterilisation validation/re-validation and sterile adoption requirements.
  • Develop or assist in development of inspection and test methods per product specifications.
  • Perform test method validations and component qualifications as required.
  • Develop or assist in development of inspection and test methods per product specifications.
  • Develop or assist in generation of test protocols and Stability Studies in support of expiration dating.
  • Identifies quality systems engineering improvement opportunities and executes through the change management system.
  • Participates in internal audit and supplier audit programmes.

 

Essential Criteria:

  • Third level Engineer/Technical/Science qualification.
  • Min 2 years in the medical device or pharmaceutical industry.
  • Risk management experience.
  • Gauge R&R and Test Method Validation.
  • Auditor experience.
  • Working with cross-functional teams to effectively implement NPD projects, corrective actions etc.
  • Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971 and CMDR.
  • Participation in and support of external audit activities.
  • Knowledge of quality management systems ISO 13485, GMP.

 

 

 

Our highly experienced consultants are here to help find the right job for you. Apply now or get in touch with Cathal regarding this role on 059 9139070 for more information.

 

Matrix Recruitment Group is committed to providing a professional service where all CV’s are kept confidential and will not be submitted to any clients without candidate’s knowledge or consent.

Alternative Text

Recruitment Consultant: Cathal Ryan

Job Title: Senior Quality Engineer

Reference: 888018

Maximum file size: 64 MB.

Job Category

Share this job

Job Title: Senior Quality Engineer

Reference: 888018

Maximum file size: 64 MB.