Senior QA Engineer

South Wales

A leading global medical manufacturing business has created a new and rewarding opportunity for a Senior Quality Assurance Engineer to join their team in South Wales and has exclusively retained Yolk Recruitment in this search.   

You’ll support the group’s QA functions from a global perspective, involving direct engagement with QA departments internationally as you support an integration of quality systems across the group.  You’ll develop and lead the implementation of risk management principles and practices for both new product development and existing product lifecycle management and will support the drive to meet the requirements of forthcoming IVD regulations. 

This is an opportunity to develop a framework for your own career development and contribute in areas where your interests and business needs combine in an agile business that has a strong record of consistent growth and investment, a strong culture of empowerment with supported autonomy to achieve your personal and professional goals, and in a role that will allow you to make a visible impact on a wide scale. 

This is what you’ll be doing

• Develop and lead a global approach to the implementation of risk management principles and practices for both new product development and existing product lifecycle management.
• Champion the design control process to ensure effective and efficient introduction of new product.
• Develop and support a global implementation of harmonized approaches to key Quality Management System elements, particularly with respect to the forthcoming IVD Regulation.
• Collation, analysis, and presentation of quality performance KPIs and identification and mitigation of any potential areas of weakness.  Analyze and monitor key quality metrics and develop action plans to address unfavorable trends.
• Support product and process root cause investigations by collaborating with product support, engineering, and operations across the Group.
• Lead and promote continuous improvement activities by seeking out opportunities to optimize processes and systems to reduce variation and improve product quality.  Drive implementation of best practices to eliminate repeat quality events and improve product quality.
• Support and participate in inspection readiness activities by applying working knowledge of ISO13485 and 21CFR Part 820 regulations.
• Support the mentoring and development of QA personnel across the Group in application of quality engineering principles. Provide coaching, training, and technical guidance to business partners in aspects of the company quality system requirements as they pertain to manufacturing quality and provide guidance of effectively applying key quality principles and tools.
• Develop and maintain internal awareness and knowledge of regulatory standards, ensure compliance of the internal quality system, and provide suitable interpretation key partners and stakeholders.

This is the experience you’ll bring to the team

• B.S. Degree in Chemistry, Biochemistry, Biology, Engineering, or a related discipline.
• Circa 5+ years’ experience in Quality in a highly regulated manufacturing environment (Medical Device, Diagnostics, Pharmaceutical, or Consumer).
• Practical experience of Risk Management (ISO 14971), or experience implementing a harmonised approach for a particular aspect of a global/multi-location QMS
• Required Travel (domestic/international) is less than 20%.

And this is what you’ll get in return

• A market leading permanent salary
• 25 days + 3 days at Christmas/New Year + bank holidays
• 5% employer contribution pension
• Working From Home options (with location suited to visit site as required)
• Flexible core working hours
• Private health insurance
• Professional / career development opportunities
• A great place to work.

If you feel you have the skills, experience and passion to be successful in this role apply now.  

*Please note, whilst we do our best to contact all candidates, due to the high number of applications we receive we cannot guarantee this for every role. If you have not heard anything from us within 7 days of applying - then unfortunately you have been unsuccessful. Please keep an eye on our website for more opportunities.