Job Description
If you are looking for a company with a global reach that can offer you excellent career opportunities and personal development along with a local collaborative team, this may be the opportunity for you.
This role offers a brilliant chance to continue your growth and development within the Operational QA area and take ownership of aspects of your role while working in a supportive and nurturing environment.
Key Responsibilities:
* Support 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.
* Analyze customer complaints: returns, analysis reports, and complaint trends.
* Validation: Define process and product validation requirements, protocols, and reports approval.
* Compile required Regulatory documentation.
* Perform internal quality audits.
* Implement Lean Manufacturing across the site.
* Transfer and implement product and processes from development or from 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 in a dynamic manufacturing environment.
* Rapidly learn and use new applications.
* Working knowledge of FDA, ISO13485, and medical device industry quality requirements.
* Experience in problem solving and process improvement methodologies.
* Process Validation, Risk Management, CAPA experience.