Senior Process Engineer

Benefits
Gain exposure in both medical device and pharmaceutical operational activities whilst working in a company with a positive team culture.

About the Company
With over 30 years experience in research and design, Cyclomedica brings an innovative and niche product to the healthcare industry. Cyclomedica are driven by enhancing and developing medical innovations for diagnostic imaging, specialising in lung health. This is an exciting time to join the organisation as they embark on obtaining new market share and enhancements of their products.

About the Opportunity
You will investigate and review the utilisation of personnel, equipment and materials as well as processes and established practices. This will facilitate the continuous improvement in the efficiency of operations. You will also be ensuring documentation is compliant with the QMS and relevant regulatory requirements.

Duties

• Support and coordinate the implementation of engineering systems / processes 
• Ensure all engineering related activity documentation is compliant with regulatory requirements and the QMS 
• Participate in risk assessments and validation activities on production processes
• Revise and adhere to SOPs, Device History Records (DHRs) and Forms (FRMs) as required
• Manage Change Controls and investigate non-conformances in relation to the Operations Team
• Participate in complaint investigations as required.

Skills and Experience
• Tertiary qualification in Science, Engineering, Computer Sciences or relevant discipline
• Experience in a similar role within the medical device, pharmaceutical or other relevant industry in either Operations or Quality Assurance

Culture
Collaborative team environment. Cyclomedica values integrity, innovation, and quality whilst manufacturing and developing innovative technologies.

How to Apply
Click apply or contact Madeleine Byrnes, Sourcing Consultant on 0288778703 for a confidential discussion.