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Contact Info
Niamh Hlubek
Life Science

+353 87 114 6347
[email protected]
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Details

Quality Engineer II- Production Support Onsite


Reference:A010196 (ANQM-305062) Location: Galway
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: €55000 - €60000
May be suitable for: EHS Engineer, Quality Engineer

A010196 (ANQM-305062)


Quality Engineer II- Production Support
Onsite role- Outskirts of Galway (Athlone side)
4 day compressed working week.


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

  • Partner with R&D and Process Engineers to ensure that the transition of products through R&D and sister sites, product approval and manufacturing scale up are smooth, timely and cost effective.
  • Promotes compliance and excellence within the company to customer requirements and the applicable regulatory standards.
  • Participates in new product/technology development and supports the QA activities as part of an overall project team.
  • Executes the project design plans, protocols and generates reports for new product development projects as well as design/process changes.
  • Summarizes, analyses and in conjunction with the team draws conclusions and makes appropriate decisions from test results and other process related findings.
  • 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.
  • Develops and executes required validations in line with regulatory standards to include equipment, process and product validations.
  • Conducts root cause analysis and implements corrective action in a timely manner.
  • Conducts audits, including closing out audit findings and creating and determining proper corrective and preventative action.
  • Creates and maintains company quality documentation.
  • Deals with suppliers and ensures their quality standards are in line with company standards.
  • Managing and investigating customer complaints including carrying out failure mode analysis and implementing required CAPAs relating to complaints where required.

Qualifications
  • An Engineering or Quality Assurance Degree or equivalent experience.
  • A minimum of 3 years post qualification experience as a Quality Assurance Engineer within a Medical Device or regulated environment.

Competencies and Attributes
  • Demonstrable detailed working knowledge of the medical device industry.
  • An analytical approach to problem solving.
  • Is creative, continually learning and exploring new ideas.
  • A self-starter that applies their own initiative in most situations.
  • A good team player, who works well in a small team environment, must be able to work effectively with peers in other Departments.
  • A good communicator who can easily convey his/her ideas and requirements across all levels in the organisation.
  • Capacity to make sound judgements while learning from mistakes.
  • Detailed knowledge of the regulatory environment in which the business operates including FDA, European, Canadian, Japanese and other International Regulatory requirements.
  • Attention to detail while maintaining awareness of longer-term objectives.
  • Strong interpersonal skills, a demonstrated ability to influence his/her peers and place quality at the forefront of everyone’s daily agenda.
  • Displays the highest levels of integrity.
  • Capacity to maintain the highest levels of confidentiality internally and externally.
  • Ability to stay connected to multiple projects simultaneously.

Any applicant must have an existing work visa/ permit to work in Ireland. Note this is an onsite role. Remote work is not an option for this role.