Job Description
This is a brilliant opportunity for an individual who wants to continue their growth and development within the Operational QA area. The role offers a chance to fully own aspects of their job while working in a supportive and nurturing environment.
A bit more about the responsibilities:
* Supporting in the supervision of Quality Technicians and QC Inspectors.
* Driving and implementing process improvements to ensure predictable processes across all product lines.
* Providing effective and responsive QA support to Operations.
* Ensuring all failure modes in process have been identified and addressed.
* Driving and implementing plant wide quality system improvements.
* Ensuring Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies.
* Providing functional expertise to other support functions on quality related issues.
* Approving change requests for product, process and quality system changes.
* Analyzing customer complaints: returns, analysis reports and complaint trends.
* Validation: defining process and product validation requirements.
* Compiling required Regulatory documentation.
* Reviewing MRB trends and identifying corrective actions when required.
* Performing internal quality audits.
* Supporting the implementation of Lean Manufacturing.
* Transferring and implementing product and processes from development or another manufacturing facility.
Requirements:
* 2-5 years' experience in Manufacturing or Quality in a highly regulated environment.
* Level 8 qualification in Engineering or related technical/Quality discipline.
* Demonstrated ability to work with cross functional organisations to solve problems.
* Rapid learning and using new applications.
* Working knowledge and understanding of FDA, ISO13485, and the medical device industry quality requirements.
* Experience in problem solving and process improvement methodologies.
* Process Validation, Risk Management, CAPA experience.