A vacancy has been announced for a Quality Engineer with a global technology company entering the medical device industry. The position based in Switzerland, is offering an exciting opportunity to join an innovative and entrepreneurial organisation to provide expertise and further develop a career in the medical sector.
- Responsible for the successful implementation of projects and management of activities to define, design, develop and deliver new processes, quality improvement and change initiatives.
- Execute process, equipment, tooling, and test method validations on new and existing processes/equipment.
- Apply knowledge of process control tools, statistical sampling, and other analytical techniques to maximize the quality and flow of product through the production line.
- Identify any problems in the process or with the equipment and designs testing to determine possible causes or solutions.
- Assists in ensuring product development activities have all necessary Quality Engineering supporting justifications.
- Interacts with third party customers, outside testing laboratories and provides Quality Engineering assistance where needed on specific issues.
- Assists in identifying root causes and coordinate corrective action to quality issues in Packaging and Inspection and the Sterile Facility.
- Training inspectors, SQC technicians, and supervisors on the following: new procedures, new equipment, new measurement methods, new inspection criteria, Component/product defects and failure modes.
Skills and Requirements
- Minimum Bachelor's degree in Engineering, Life Sciences, or Physical Sciences
- Electrical Engineering or related experience and/or training strongly preferred
- Master's Degree in an engineering discipline preferred
- 5 years+ experience in medical device, pharmaceutical or other highly regulated industry preferred
- Experience in leading and facilitating risk assessments for process and product development/improvement
- High-level of insight into design, development, and lifecycle management of products and processes
- Working knowledge of statistical analysis software (e.g. Minitab)
- Experience with developing and implementing methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment
- Strong written and verbal communication skills
- Experience supporting 3rd party inspections and audits (e.g. FDA, Notified Body, or Customer Audit)
- Understanding ISO 14971 and FDA Guidance
- Experience leading Continuous Improvement projects around new product development and life-cycle management processes
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have questions, please contact Josh Volpe at 0203 800 1292 or upload your CV on our website - www.proclinical.com
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.