Senior 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 platform. In 2014, after eight years of intensive software development, we launched Kneat Gx—the world’s most advanced validation software to help revolutionize the speed, precision, transparency, and intelligence of validation in the Life Sciences sector. Our solution is now used by some of the world’s leading Life Sciences companies.
What we’re looking for
As Kneat continues to expand, we are looking for an enthusiastic Senior QA Compliance Engineer to join our QA Compliance Department.
Position overview
The QA Compliance team at Kneat manages and maintains an integrated management system which complies with ISO 9001:2015 QMS and ISO 27001:2022 ISMS requirements. The team works collaboratively with all departments within Kneat to ensure that quality, information security and compliance are the cornerstone of all aspects of the company’s operations and that all customer, business and certification requirements are met to the highest degree of satisfaction.
The Senior QA Compliance Engineer is responsible for supporting the QA Compliance Manager as a Management System’s subject matter expert and supporting the implementation and evolution of all aspects of Kneat’s own Integrated Management System. The successful candidate will own and deliver department and business-level objectives while maintaining best-in-class compliance processes.
This is not a QC Test Engineer role nor a Validation Engineer role.
Responsibilities
* Act as IMS subject matter expert for junior members of the QA compliance team, other functions and business projects.
* Educate and train the QA Compliance team, as required, on best practice ISO and SOC 2 compliant processes.
* Support the QA Compliance Manager in guiding and prioritising the QA Compliance Team’s priority and workload.
* Support the QA Compliance Manager in customer-facing activities.
* Identify and deliver continuous improvements to Kneat’s Integrated Management System (IMS).
* Lead internal compliance audits and input results into the management review process.
* Manage, review and approve compliance documentation ensuring that the IMS is always audit-ready.
* Co-lead and support external certification and customer audits.
* Continuously assess QA Compliance processes to identify opportunities for process improvement.
* Report to management on the conformance/compliance state of the IMS based on internal and external audits.
* Track and monitor the implementation of corrective actions to ensure deficiencies are addressed.
* Advise stakeholders on the status of investigations and associated corrective actions and commitments, as appropriate.
Minimum qualifications
* Degree or higher in quality management, engineering, science or similar discipline.
* 8 years+ experience working in a Quality Systems or Quality Assurance role.
* Experience with ISO9001, ISO 27001, 21 CFR Part 11 and Gamp 5 requirements and/or requirements for systems qualification in a regulated environment.
* Subject matter expert experience in good documentation practices, change control, risk analysis, root cause investigation, complaint handling, non-conformances, corrective actions, etc.
* Proven internal lead auditor experience.
* Experience in leading and directly supporting customer audits.
* Advanced writing and communication skills.
* A passion for quality in a leading-edge technology-based organisation.
* Ability to work well independently or as part of a team.
* Knowledge and understanding of IT / Life Sciences industry regulations, including FDA and GxP requirements, is a preference.
What we offer you
At Kneat, we truly value ideas and collaboration so we’ve created an environment that builds, protects, and celebrates teamwork. Our strong culture is central to our continued success. We offer programs and rewards that one would expect from a highly successful and growing technology company.
* A fantastic culture, team, and energy.
* Competitive compensation.
* Comprehensive benefits package.
* Flexible hybrid work arrangements.
* Training and professional development.
Kneat is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to Equal Employment Opportunity (EEO) regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or veteran status.
Reasonable accommodations may be made to enable qualified individuals with disabilities or special needs to perform these essential functions. If you have a disability or special need that requires accommodation to complete this application form, please contact us at +353 (0)612 038 26 (Ext 2004) or email us at hr@kneat.com for assistance.
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