Quality Assurance Engineer

Posted 28 September 2021
SalaryNegotiable
LocationGalway
Job type Permanent
DisciplineEngineering Careers, Industrial Careers
ReferenceBBBH483819_1632901582

Job description


Title: Quality Assurance Engineer

Location: Galway

Summary:
The Quality Assurance Engineer is a key member of the Quality team with responsibility for establishing, implementing, and maintaining the Quality System on site.

Responsibilities:

  • Collaborate with R&D and Process Engineers to make sure that the transition of products through R&D, product approval and manufacturing scale up are smooth and timely.
  • Define and implement Quality standards and specifications and help make sure Regulatory requirements are met. Constantly seeks new improvements in product and process quality.
  • Partake in new product/technology development and supports the QA activities as part of overall projects.
  • Carry out project design plans, protocols, and generate reports for new product development projects, and design/process.
  • Develops and executes required validations which comply with regulatory standards to include equipment, process, and product.
  • Summarizes, analyses and in collaboration with the team, draws conclusions and makes appropriate decisions from test results and other related processes.
  • Ensures relevant process monitoring/ controls are set up to maintain an effective and validated process.
  • Conducts root cause analysis and implements corrective action in a timely manner.
  • In charge of investigating customer complaints including carrying out failure mode analysis and executing required CAPAs specific to complaint.
  • Carry out audits, including closing out audit findings to determine the correct preventative action.
  • Collaborate with suppliers to make sure their quality standards are in line with the company.
  • Maintenance of an effective quality management system in compliance with relevant regulatory requirements, including ISO13485.



Qualifications:

  • Engineering, Quality Assurance, or equivalent Science Degree.
  • Minimum of 3 years post qualification experience in a quality environment with proven quality assurance experience within a Medical Device or regulated environment.
  • Driving licence required to travel between sites if required.
  • Ability to demonstrate knowledge of medical device quality & regulatory systems and medical device directive (EN ISO13485, MDD and FDA CFR 820).
  • An analytical approach to problem solving.
  • A self-starter that applies their own initiative.
  • A team player, who works well in a small team environment.
  • A good communicator who can effectively convey his/her ideas and requirements across all levels in the CAPA, Auditing and Risk Management experience per ISO 14971.
  • Detailed knowledge of the regulatory environment in which the business operates including FDA, European and other International Regulatory requirements.
  • Attention to detail while maintaining awareness of longer-term.
  • Excellent interpersonal skills, a demonstrated ability to influence his/her peers and place quality at the forefront of everyone's daily agenda.
  • Excellent organisational skills and ability to track and drive activities to closure.
  • Displays capacity to maintain the highest levels of confidentiality internally and ability to manage multiple projects.

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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.