Our partner is active worldwide in the development and production of medical devices. They are a leading company within this sector and they are market leaders within a number of product groups.
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.
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
- Team Participant: Key member of a team of QA personnel. Contributies to the development of clear targets and expectations for self and 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.
- 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.
- 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.
- 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.