Descripción del Trabajo
- The Quality Lead is responsible for the full ownership of a particular area of the QMS or quality function including, but not limited to: Supplier Quality, QMS, Validation, Metrology, Workcell, Quality Engineering and other areas assigned within the quality unit. The quality lead will be seen as the company point of contact for their particular area of quality and must represent their area and the company in the highest possible standard.
Key Responsibilities and End Results:
- Lead & coordinate the key activities and priorities pertaining their area of the quality function
- Ensure their area of the quality function achieves compliance and is audit ready at all times
- Utilizes their influence to ensure compliance is maintained across the areas they interact with
- Coaches and mentors all stakeholders to ensure compliance requirements are understood
- Acts as the subject matter experts of particular areas of the quality function or plant
- Understands and delivers against each of the Jabil competencies
- Develops self and others to ensure they and their team members are developing effectively
- Maintain’s a level headed approach to challenges presented on a day to day basis
- Exercises exceptional judgement regarding quality decisions to ensure the quality and business needs are served
- Approaches quality from a proactive perspective
- Understands the NWQS documentation within their area and can present the information effectively to external parties
- Completes quality and business assignments on time and to the correct Jabil standard
- Maintains strong collaborative ties up, across and down through the organization
- Drives exceptional levels of customer services
- Manages the Key Performance Indicators in their area
- Adheres to all Workday requirements as assigned (recruitment, goal setting, goal adherence, performance reviews)
- Understand risk management and establishes high standards of risk management within their area
- Manages quality agreements as applicable to their area (supplier, contractor, customer)
- Coordinates as required critical business reviews with suppliers/customers
- Executes quality audits as assigned
- Stays abreast of regulatory requirements and ensures their areas are kept up to date
- Supports all company Lean Manufacturing principles
- Provides innovative solutions within their areas that improve product quality and/or efficiency.
- Constantly seeks to improve work processes; Has a quality-first mentality; Learns from internal and external best practices to apply to her/his work
- 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
- Brings high levels of energy to their role at all times
- BSc Degree in a life science (or similar) discipline.
- 5 years’ experience in manufacturing (preferably Medical Device/Pharmaceuticals)
- Organisational and planning skills are required to plan, execute and track quality commitments
- Working knowledge of ISO 13485 &/or Pharmaceutical EU GMP (Eudralex Volume 4)
- Experience of performing audits of quality systems to ISO/GMP standards
- People Management experience is essential.
- Excellent accuracy and attention to detail
- Excellent IT, communication and interpersonal skills to communicate well, both verbally and in writing.
- Ability to work off own initiative and as part of a cross functional team
- Desire to lean new tasks and flexibility
- Quality Manager, Quality/Validation/Metrology Engineers, Technicians & Team Members.
- Plant wide Managers, Leads and Team Members