Currently we are looking for an experienced Senior Quality Assurance Engineer for our Quality Assurance Team. The position will have the responsibility to execute, maintain and develop Global CAPA and Non-conformity policies and processes. You will ensure a global management of CAPAs and Non-conformities and create awareness related to quality management. The Senior Quality Assurance Engineer will also support in securing compliance by performing internal audits and take part in the execution, maintenance and development of the corporate audit program.
Your key accountabilities
- Execute, maintain and develop global policies and processes for CAPA and Non-conformities
- Coordinate, follow-up and drive global CAPAs and Non-conformities to completion
- Actively engage in Global CAPA Review meetings
- Track and analyse quality performance metrics
- Ensure awareness of and provide training in global CAPA and Non-conformity policies and processes
- Participate in regulatory and quality system audits as subject matter expert for the global CAPA and Non-conformity processes
- Perform corporate internal audits and support the adherence to the corporate internal audit program
- Engage in quality and business related issues and/or opportunities
Who we are looking for
You are passionate about quality and have a high level of integrity. You have a process-driven, structured and analytical mind-set and you are self-managed and self-motivated.
You have strong written and verbal communication skills and the ability to work with individuals across all levels of the organisation, as well as senior management and external bodies.
- Bachelor’s or Master’s degree in Engineering or equivalent
- Certified Lead Auditor for ISO 9001 and/or ISO 13485
- Minimum 5 years of experience of working with Quality Management Systems, CAPA and/or Non-conformity handling, preferably within Medical device companies
- Extensive knowledge of FDA and ISO regulations
- Experience with Root Cause Analysis and application of those techniques
- Excellent data collection, analysis and reporting skills
- Experience from work in an international organisation or environment
- Good command of written and spoken English
To apply for the position, please send an up-to-date CV to firstname.lastname@example.org or alternatively call me on 0161-212-2308