Job Description
An Opportunity for Growth and Development in Operational QA.
We are seeking an individual to support the supervision of Quality Technicians and QC Inspectors, drive process improvements, and ensure predictable processes across all product lines.
The role involves providing effective QA support to Operations, ensuring regulatory compliance, and providing functional expertise on quality-related issues.
Responsibilities:
* Supporting in the supervision of Quality Technicians and QC Inspectors
* Drive and implement process improvements to ensure predictable processes across all product lines
* Provide effective and responsive QA support to Operations
* Ensure all failure modes in process have been identified and addressed
* Drive and implement plant-wide quality system improvements
* Ensure Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies
* Provide functional expertise to other support functions on quality-related issues
* Approval of change requests for product, process, and quality system changes
* Customer complaints: analysis of returns, approval of analysis reports, and analysis of complaint trends
* Validation: Define process and product validation requirements, preparation, and approval of Master Validation Plans, protocols, and reports approval
* Compilation of required Regulatory documentation
* MRB: Review of MRB trends and identification of appropriate corrective actions when required
* Perform internal quality audits
* Support the implementation of Lean Manufacturing across the site
* Transfer and implement product and processes from development or from another manufacturing facility
Background, Education & Experience:
* 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 in a dynamic manufacturing environment to solve problems
* Ability to rapidly learn and use new applications
* Working knowledge and understanding of FDA, ISO13485, and the medical device industry quality requirements associated with manufacturing and supplier controls
* Experience in problem-solving and process improvement methodologies
* Process Validation, Risk Management, CAPA experience