Associate QA Compliance Engineer

Associate QA Compliance Engineer

Kneat enables regulated organizations to move from paper-based validation to intelligent digitized paperless solutions. And we do it through the ongoing development of a powerful purpose-built software 2014 after 8 years of intensive software development we launched the worlds most advanced validation software to help revolutionize the speed precisiontransparencyand intelligence of validation in the Life Sciences sector. The solution is now used by some of the worlds leading Life Sciences companies.

As Kneat continues to expand we are looking for an Associate QA Compliance Engineer to join our QA Compliance Department.

Position Summary

Reporting to our QA Compliance Manager the Associate QA Compliance Engineer will be responsible for supporting daily quality operations associated with software development and delivery and supporting the implementation and management of all aspects of the Quality Management System (QMS) within the organization.

The successful candidate willwork collaboratively with software developers IT staff account managers other QA personnel and business stakeholders to ensure that quality and compliance are the cornerstone of all aspects of the companys operations and that all customer business and regulatory requirements are met to the highest degree of satisfaction.

Primary Responsibilities

• Support the implementation and continuous improvement of Kneats integrated management system (IMS).
• Internal IMS audits and input into management reviews.
• Ensuring that all project documentation is delivered into the QMS.
• Approval and management of project documentation and other project deliverables ensuring that projects are always audit-ready. Maintain QA dashboard and metrics.
• Regulatory and customer audit support; always ensuring audit readiness.
• Supporting external vendor audits.
• Assessment of compliance systems on ongoing basis to identify opportunities for process improvement.
• Reporting to management on the conformance/compliance state of our QMS based on internal audits.
• Supporting the customer complaints process.
• Tracking and monitoring the implementation of corrective actions to provide assurance that deficiencies have been addressed.
• Provision of training on quality systems and methodologies to company personnel.
• Advising relevant personnel on the status of investigations and associated corrective actions and commitments as appropriate.
• Review and approval of qualification/validation documentation.
  
  

This is not a QC Test Engineer role nor a Validation Engineer role.

Minimum qualifications

• Degree or higher in a science engineering IT or similar discipline. (experience will be considered in lieu of education)
• 2 years of experience working in a Quality Systems or Quality Assurance related role.
• Understanding of ISO9001:2015 requirements and/or requirements for systems qualification in a regulated environment.
• Experience in change control risk analysis root cause investigation complaint handling non-conformances corrective actions etc.
• Effective writing and communication skills.
• A passion for quality in a leading-edge technology-based organization.
• Ability to work well independently or on a team.
• Proven knowledge and understanding of IT/Life Sciences industry regulations including FDA and GxP requirements.
• Experience of participating in customer vendor audits

What We Offer You

At Kneat we truly value ideas and collaboration sowevecreated an environment that buildsprotectsand celebrates teamwork. Our strong culture is central to our continued success.

We offer programs and rewards that one would expect froma highly successfuland growing technology company:

A fantastic culture team energy and a high-growth successful company

• Competitive salary and benefits
• Flexible work arrangements
• Health benefits
• Training & professional development

We invite interested applicants to share their resume and cover letter.

Weoperateon a hybrid working basis.

Applicants must have a permanent Irish working visa.

Successful applicants will be subject to references and a background check.

Reasonable Accommodations Statement: To perform this job successfully an individual must be able to perform theaforementioned dutiesand responsibilities satisfactorily. Reasonable

accommodations may be made to enable qualified individuals with disabilities to perform these essential functions. Kneat is an equal opportunity employer

Required Experience:

Manager