Job Description
Within the Coronary Design Assurance Group, we focus on providing Quality support across all aspects of PDP from pre market product development to post market product surveillance. We participate in the design process to ensure the performance and safety of the coronary devices we develop, is assured and maintained throughout the product lifecycle.
Responsibilities
- Ensure, maintain and enhance compliance within Design Assurance Laboratory
- Lead Laboratory team in Quality decisions and behaviours
- Adhere to all Design Assurance Laboratory and relevant site wide procedures and practices for Safety & GMP
- Support review and release of test data
- Develop & maintain a deep understanding of processes and products to support process improvements
- Lead Audit preparation and follow up
- Drive laboratory investigations, identifying root causes using robust root cause analysis tools and sound engineering principles
- Initiate corrective and preventative actions and follow through to implementation
- Support Change Control - Initiate Change Orders to support documentation updates, draft changes & justifications and drive to completion in a timely manner
- Devise and lead continuous improvements activities within the Design Assurance Lab
Requirements
- Minimum of Degree level 8 in Engineering / Science or related discipline with a minimum of 2 years of relevant experience.
- Experience working in the medical device or other regulated industry.
- Ability to collaborate with and influence groups in a positive, team based environment
- In-depth knowledge of GMP and documentation practices for a technical/professional working environment
- Strong analytical/problem-solving skills
- You must think critically and make sound decisions
- Fosters collaborative relationships within the team and across the organization
- Excellent oral and written communication skill
- Be focused on patient and customer and set high standards, instil operational excellence, and drive accountability
