Senior Quality Engineer position in an innovation driven Medical Device Company. An exciting opportunity for a Senior Quality Engineer looking for a next step in his/her career, in an innovative and international high-tech organization to help increasing quality of life.
The Senior Quality Engineer participates both within an Operations environment as well as a New Product Development environment. Typical tasks for the Senior Quality Engineer are:
• Preparing & executing internal audits & DHF audits (ISO 13485, ISO9001, cGMP);
• Initiating & coordinating complaint handling, NCR’s & CAPA’s;
• Preparing & organizing the Quality System Management Review meeting;
• Supplier assessments;
• Coordinating cleanroom monitoring and corrective actions;
• Coordinating bioburden monitoring, Endotoxin monitoring & Periodic Dose Audits;
• Procedure training new employees;
• Maintenance of Quality procedures, – guidance’s and – templates;
• Review of Engineering -, Qualification – & Validation protocols and reports;
• Review of specifications, calibration – & maintenance records.
• BS or MS Degree in Engineering (e.g. Industrial Engineering);
• Experience in Quality Engineering in Medical Device Industry, both in an Operations environment and a Product Development environment;
• Highly committed, respectful, trustful, eager, demonstrates ownership;
• Creates alignment between cross functional team members through effective communication, seeks cross-function cooperation;
• Has sufficient technical knowledge to enable high level communication with development – and manufacturing engineers;
• Able to write clear reports, delivers presentations effectively to small and large groups;
• Can define objectives and break down into executable tasks with scheduling and tracking for overall plan execution; can prioritize activities by importance and meet tight deadlines;
• Experience with applying design control and product and process validations;
• Experience with applying the six sigma methodology (pre);
IMDS (Interventional Medical Device Solutions) is focused on providing innovative (minimal invasive) Medical Devices to help patients improving their quality of life. IMDS is dedicated to advancing the science of Medical Devices through continuous development of innovative and advanced technologies that enhance patient outcomes and improve practitioner productivity. IMDS, Roden, The Netherlands, (~85 employees) is equipped as a Centre of Excellence in order to develop, improve and manufacture innovative solutions for Medical Devices. When you join IMDS, you’re part of an international team that is helping to improve quality of life. IMDS offers the excitement and growth potential of an agile company with the strength and stability of an established industry leader. The environment is fluid and fast-paced, and the people work together to make a difference every day. The atmosphere is friendly and team-oriented. Working at IMDS gives you the opportunity to make a positive impact on the lives of others. IMDS is committed to building and maintaining a workforce that reflects the diversity of its global customer base.
• Engaging international working environment in a modern working location;
• Challenging job position with corresponding responsibilities;
• A competitive remuneration package.
Florence Wagter (Director QA/RA), or Jeroen Bastiaan (Director HR)
Telephone: +31(0)50 8200230
Recruitment by commercial agencies in relation to this or other vacancies is not appreciated.