About Your New Employer:
* Global provider of microfiltration products and single-use systems used in pharmaceutical and biopharmaceutical processes
* Support the production of life-saving therapies for global pharma clients.
* Work cross-functionally with exceptional SME team members to drive quality improvements.
About Your New Job as Quality Systems Engineer:
* Collaborating with commercial and technical operations teams to deliver QA objectives and support business growth.
* Tracking and reporting metrics and key performance indicators for the Quality Management System.
* Identifying and supporting value-added improvements and key performance indicators with stakeholders.
* Reviewing and following up on open actions related to Corrective and Preventative Actions (CAPA), Out of Specification (OOS) reports, and Deviations.
* Supporting and hosting Client quality audits, including addressing findings and required actions.
* Managing the Internal Audit program, coordinating audit schedules, reviewing findings, tracking corrective actions, and driving continuous improvement.
* Providing forward-thinking innovative solutions and identifying opportunities to add value to the team's deliverables.
* Assisting in the development of systems and processes to ensure delivery of information across functions to support enhanced performance culture.
* Leading Document Control at the site, managing SOPs and Document Control.
* Managing quality training programs at the Castlebar site to ensure compliance with HQ standards.
* Leading training compliance to SOPs at the site.
* Performing other duties as required to support the growing Quality organization.
What Skills You Need for Quality Systems Engineer:
* Minimum 3 years of professional experience in the pharmaceutical industry in a Quality Assurance-focused role.
* Ability to integrate with organizational Core Values, culture, and team climate.
* Detail-oriented with the ability to focus on the details while understanding the overall direction.
* Self-motivated, identifying what needs to be done and doing it proactively.
* Results-driven, setting challenging goals and meeting or exceeding them.
* Adept at multi-tasking and working in a fast-paced environment.
* Strong, clear, and concise communicator both internally and externally with pharmaceutical clients.
* Bachelor's degree in science, engineering, or business preferred.
* Willingness and availability to travel on company business.
What's on Offer:
* Competitive salary
* Benefits package including training and development opportunities
* Career path with opportunities for growth and advancement
* Collaborative and dynamic work environment