LEAD QUALITY ENGINEER - Medical Devices
Reporting to the Manager, EME & MEATI Quality Assurance and acting as a key member of the International Quality Department. The Lead Quality Engineer (EME & MEATI) will have shared responsibility for the company’s Quality Management System (QMS) and in ensuring compliance with company and external Regulatory Authority (e.g. N.B. & CA) requirements as they relate to the formal QMS and Complaint Handling process.
The Lead QE role will support manufacturing in terms of corrective action and the implementation of CAPA for products and systems. Assist other WA site / facility Quality assurance teams in manufacturing issues, internal audits and SAP quality process improvements. The role of Lead QE will be key in ensuing compliance with quality system requirements for all existing and new products and projects.
Principal Duties/ Responsibilities: Similar and related duties may be required; main responsibilities include:
- Team Participant: Key member of a team of QA personnel. Contributies to the development of clear targets and expectations for self and team. Encourage and motivate self and others to achieve agreed levels of team and individual performance. Participate and contribute to regular cross-functional meetings. Encourage open communication among cross-functional teams and support other (junior) team members through education, leadership and constructive feedback Implement initiatives to maintain the motivation, morale and performance of the team.
- Communication. Contribution towards implementation of necessary communication strategy for the improvement and awareness of all QA activities across all departments throughout the EME & MEATI sites. Interfacing with other departments and functions, including Operations / R & D /Finance / Customer Care & Sales and Marketing to resolve problems. Actively seek feedback from internal customers and team members regarding issues and escalate relevant issues to the appropriate people to create an environment of continuous improvement and service excellence. Consult on and identify opportunities for improving the operation of all aspects of the Navan, Tilburg & Casalecchio sites & EME & MEATI Quality Assurance activities.
- Reporting. Regularly report relevant updates to the team and manager. Proactively seek to keep up to date with all information relating to ongoing corporate Quality Assurance activities and all relevant internal tools, processes, procedures and working practices. Ensure compliance with the relevant legislation and regulations and understand the importance of operating within the guidelines. Central control point for collecting and addressing issues in relation to all aspects of Navan, Tilburg & Casalecchio site & EME & MEATI Quality Assurance activities.
- Aid and develop WA quality/manufacturing/service and SAP processes at the Tilburg site / facility, as well as in other WA sites / facilities. And to assist in achieving and maintaining Internal Audit schedules at other WA sites / facilities.
- In conjunction with Corporate Quality Assurance & Regulatory Affairs, leads the Quality Assurance activities for the entire Navan/Tilburg site & EME & MEATI processes.
The ideal candidate will have worked for at least five 5 years in a similar position or responsible position with quality process focus and project management skills. The work environment is a changing, dynamic environment, where a need to adapt to change easily, show flexibility, prioritization, organization and time management skills are a pre-requisite.
- Degree in quality, engineering, science or related field.
- Knowledge of Quality Systems (ISO 9001, ISO 13485, QSR), Medical Device Directive (93/42/EEC), Regulation (EU) 2017/745, FDA (US CFR) and GxPs.
- Certification as an ISO 9000 Lead Auditor or by one of the following RAB, QMI, IRCA, etc.
- Trained and capable of training others in quality assurance, quality control, and quality system assessment.
- Process/Manufacturing Engineering calculation knowledge.
- Project management background / skills.
- Involvement in recommending process or procedural improvements up to the department level.
- Demonstrated interpersonal flexibility and strong team skills. Strong organizational skills and ability to plan and manage own work effort and that of others. Proven ability to exercise good judgement. Reputation of being results and quality driven.
- Excellent oral and written communication ability. Evidence of research and problem-solving skills.
- Proficient keyboard and computer skills including excellent knowledge of Excel and MS Word, or equivalent spreadsheet, and word processing applications. Knowledge of SAP or similar order management and processing systems.
- Numerate and accurate, particularly in relation to data entry, document processing and data integrity.
- Willingness to travel max 20% of time between WA sites and external suppliers. Normal hours of business are Monday to Friday 9am to 5pm. You are required to be flexible around these hours, as the business serves markets in various time zones.