Design Assurance Engineer (Remote)

CREGG Recruitment are currently hiring a Design Assurance Engineer for a large medical company in Galway: For more information please call Breda Murphy at CREGG Recruitment 0860262157 email breda@cregg.ie

Job Purpose:  

Fulfil the quality assurance responsibilities of new product development and value improvement projects support, including: 

  • Demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality.
  • Understanding and complying to quality, business, health & safety systems and market/legal regulations governing the quality systems. 
  • Removing or mitigating against risks associated with the design, use and manufacture of devices. 
  • Ensuring commitment to training requirements and understanding and complying with all regulations governing their work. 

Salary & Benefits: This role is fully remote & excellent rates apply

 

Key Responsibilities: 

General 

  • Completes work assignments under limited supervision/guidance. 
  • Interfaces with R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres and Post Market Quality Assurance team environment providing technical and quality systems input. 
  • Familiarity with requirements and procedures that govern medical device Design Control & Risk Management. 
  • Identifies and resolves complex exceptions to work assignments. 
  • Seeks to support improvements in product and process quality. 
  • Builds Quality into all aspects of work by maintaining compliance to all quality requirements. 
  • Excellent interpersonal and communication skills with good leadership abilities. 

  Technical 

  • Provides both quality and technical input to ongoing product development and post market commercial product activities. 
  • Experienced in risk management, design and process change, standards compliance (to regulatory requirements).
  • Knowledge of materials (polymers and metals), drugs, sterilization of medical devices. 
  • Provides design quality support in the resolution of PIRs, complaints investigation, CAPAs, VIPs, regulatory requirement changes. 
  • Excellent analytical and problem-solving abilities. Analyses, draws conclusions and makes appropriate decisions from risk management activities and test data. 

Leadership 

  • Is an active team member completing quality deliverables associated with new product development and post market (commercial product) support. 
  • Coaches others in areas of expertise. Gives technical guidance to junior team members. Uses opportunities in project assignments to develop self & others. 
  • Is a fully motivated team member – achieves and demonstrates best practices in line with set objectives. 
  • Is willing to implement changes within the project/department practices and supports a culture of challenging the status quo to create best in class. 

 

Qualifications & Experience:

  • HETAC Level 8 in a STEM discipline with a minimum of 3-4 years’ experience in a similar role in Mechanical, Biomedical or related engineering discipline.
  • Good technical capabilities, communication skills, teamwork abilities and initiative.
  • Proven ability to work well as part of a team & on own with minimum supervision.

 

 

+ Apply

Related Jobs

191 results found in the Engineering & Electronics sector

Electrical Design Engineer

  • Location: Galway
  • Job Type: Temporary
  • Ref: 17085
  • Date Posted:

Purpose: To provide Electrical and Safety design expertise to the Equipment Engineering department in the design, manufacture, documentation, and continuous improvement of equipment to produce medical devices. Responsibilities: Generation of…

process (extrusion) technician ND

  • Location: Galway
  • Job Type: Temporary
  • Ref: 16759
  • Date Posted:

Cregg Recruitment are currently hiring a Extrusion Technician to work in large medical device in Galway for more information on this call Stephen Coen 0861030418 About the job:   Hours…

Maintenance Technician

  • Location: Galway
  • Job Type: Contract
  • Ref: 16665_2
  • Date Posted:

CREGG Recruitment are currently hiring Manufacturing Technicians to nights OR weekend shift with a world leading medical device company in Galway, Ireland.   Shift work: This is based on a…

Maintenance Technician

  • Location: Galway
  • Job Type: Contract
  • Ref: 169622
  • Date Posted:

Responsibilities: Manufacture of Formulation AU & CSCA batch’s Cleaning of tanks and use and maintenance of the CIP system. Calibration and maintenance of Production equipment. Upkeep of neat and accurate…

Assembly Technician

  • Location: Rathkeale, Limerick
  • Job Type: Contract
  • Ref: 12312
  • Date Posted:

Comprehend technical documentation drawings, operating instructions and schematics. Layout/fabricate and assemble all components of the build by analysing drawings and 3D model specifications. Set up and operate equipment/tools to build…

Can’t find the job for you?

Let us find the job made for you