The Quality Systems Specialist is responsible for supporting, maintaining, and continually improving the organisation’s Quality Management System (QMS) in alignment with ISO 13485, applicable regulatory requirements and in line with customer requirement.
This role plays a key part in ensuring the company consistently meets regulatory, customer, and business requirements through effective process standardisation, internal auditing, and QMS performance monitoring.

Key Responsibilities and End Results: (Essential responsibilities include but are not limited to the following):

• The individual will support readiness for the external Quality Management System auditing function for regulatory, customer and corporate audits.
• The Individual will support the internal Quality Management System auditing function (Lead auditor Training). Plan, schedule, and execute internal audits across all relevant department. Prepare audit reports, track findings, and drive timely closure of corrective actions.
• The Individual will support the development, implementation, and improvement of all Quality Systems within the QMS to ensure compliance is the ISO 13485 Standard.
• The Individual will administer, support and have oversight of the CAPA system, ensuring root‑cause analysis and effective corrective/preventive actions.
• Support and lead Key aspects of the QMS including (as assigned):

-Change Control

- Auditing

-Document control

-Change control

-Non-Conforming Events

-Deviations

-CAPA (Corrective Actions, Supplier Corrective Actions, Customer Complaints

- Management Review and Capa Review

• Support and mentor personnel on the key aspects of the QMS to ensure compliance and process improvement on time.
• Delivery QMS training in induction and as required.
• Implement and lead root cause problem solving approaches in a team environment.
• Collate and deliver QMS metrics and trend analysis for the site including a breakdown of QMS compliance per Workcell and relevant departments.
• Supports Operations and Workcells to maintain and improve GMP Standards.
• Seeks out and drives improvement opportunities with the QMS.
• Assists in the development and implementation of quality plans, programs and procedures using quality control statistics, Lean manufacturing concepts and analysis.
• Mentor or Coach a Team Member to develop people management skills.
• The Individual will take ownership and drive their own continuous development.
• Ensure that performance and product quality conforms to established company and customer and regulatory requirements.
• Assist in the review, analysis and reporting on quality discrepancies related to assembly and process. May investigate problems and recommend disposition, modification and corrective action for recurring or non-recurring discrepancies. Interfaces with manufacturing, engineering, customer, vendor representatives to ensure requirements are met.
• Facilitate periodic review of QMS documents with process owners.
• Monitor KPIs and quality metrics; prepare reports for management review and regulatory audits.
• Support Management Review meetings by gathering and analysing QMS performance data.
• Support the preparation and delivery of Management review and CAPA review Board Meetings.
• Support Corporate initiative in relation to changes/improvements /alignment to corporate QMS.
• Application of risk management principles in accordance with ISO14971 and EU GMP ICH Q9
• Individual will use their initiative to drive continuous improvement projects in areas of the QMS/Workcell.
• Close liaison and networking with other departments to provide and drive quality inputs and initiatives into the overall operational activities of the company.
• Devise/Update Work Instructions as required.
• Support all company safety and quality programs and initiatives.
• Ensure ongoing compliance with GMP in all practices, recording of events and processes.
• Ensure compliance with all learnings from all GMP training events.
• Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.

Job Specifications:  The minimum education and experience required to perform this job competently.   

• Level 6/7 in quality engineering/science discipline or 3 years equivalent experience.
• Basic quality control concept understanding (desirable: experience within a quality control role).
• Knowledge of Quality Management Standards - ISO 13485, Eu GMP
• Experience in internal/external audits

Skills/Attributes:

• Excellent Leadership skills, ability to motivate team members within the organisation. (Energetic & enthusiastic individual).
• Excellent organisation, communication, computer & presentation skills.
• Excellent initiative, decision making and be able to work in a core team environment.
• Solution driven with emphasis on performance and results.
• Individual with an experienced background in automation, equipment/software validation.
• Individual with an experienced background in manufacturing within controlled environments.

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Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, age, disability, genetic information, veteran status, or any other characteristic protected by law.

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