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Quality Assurance Engineer (Galway City)
- Full Time
- On site
- Mid-Senior Level
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.
- 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
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