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Quality Assurance Engineer (Galway City)

  • Pale Blue Dot® Recruitment
  • Galway

To apply for this job please visit palebluedotrecruitment.recruitee.com.

The Role

Our Client, a leading Medical device Company based in Galway is hiring a Quality Assurance Engineer following the acquisition of several innovative technologies. The Quality Assurance Engineer is a key member of the Quality team with responsibility for establishing, implementing and maintaining the Quality System on site.

 

Job Responsibilities include but are not limited to the following:

  • Partner with R&D and Process Engineers to ensure that the transition of products through R&D, product approval and manufacturing scale up are smooth, timely and cost
  • Defines and implements Quality standards and specifications and helps to ensure that Regulatory requirements are met.
  • Continually seeks to drive improvements in product and process quality.
  • Participates in new product/technology development and supports the QA activities as part of an overall project
  • Executes the project design plans, protocols and generates reports for new product development projects as well as design/process
  • Develops and executes required validations in line with regulatory standards to include equipment, process and product
  • Summarizes, analyses and in conjunction with the team draws conclusions and makes appropriate decisions from test results and other process related
  • Ensures appropriate process monitoring / controls are in place to maintain an effective validated process.
  • Conducts root cause analysis and implements corrective action in a timely
  • Managing and investigating customer complaints including carrying out failure mode analysis and implementing required CAPAs relating to complaints where required
  • Conducts audits, including closing out audit findings and creating and determining proper corrective and preventative
  • Partner with suppliers to ensure their quality standards are in line with company
  • Maintenance of an effective quality management system in compliance with applicable regulatory requirements, including ISO13485.

 

Requirements

  • An Engineering, Quality Assurance or equivalent Science Degree (or equivalent experience)
  • A minimum of 3 years post qualification experience in a quality function with proven quality assurance experience within a Medical Device or regulated environment.
  • Strong interpersonal skills, a demonstrated ability to influence his/her peers and place quality at the forefront of everyone’s daily agenda.
  • Demonstrable Knowledge of medical device quality & regulatory systems and medical device directive (EN ISO13485, MDD and FDA CFR 820).
  • Strong interpersonal skills, a demonstrated ability to influence his/her peers.
  • An analytical approach to problem solving
  • CAPA, Auditing and Risk Management experience per ISO 14971.
  • Capacity to make sound judgements while learning  from detailed knowledge of the regulatory environment in which the business operates including FDA, European and other International Regulatory
  • Displays the highest levels of integrity and diplomacy.
  • Capacity to maintain the highest levels of confidentiality internally and externally.
  • Acts in conjunction with his/her management peers as a champion of company values and standard
  • Driving licence required to travel between sites in Galway city if required

 

Our Client is offering  a competitive compensation and benefits package, including a bonus program, Defined Contribution Pension, employee stock purchase plan and stock options.

Note: By applying for this position, you may also be considered by Pale Blue Dot® Recruitment for other or future related vacancies.

Pale Blue Dot® Recruitment
“The Resource for the MedTech Workforce”

 

To apply for this job please visit palebluedotrecruitment.recruitee.com.