Product Quality Engineering Manager
- Driving a quality engineering mindset throughout the product lifecycle to secure that the product delivers to the highest standards, including design and manufacturing and service.
- Driving efficiency improvements in the application of quality engineering principles throughout the business from R&D to manufacturing, including the full design release and engineering change cycles
- Operating, developing, and improving the CAPA process to effectively and efficiently close out issues, and drive benefit through to the end customer
- Identifying and acting on customer complaints thought management of the complaint handling process including compliance of documents and procedures with intended regulations / standards, OKRs and trend analysis
- Acquiring and analysing data using appropriate methods to facilitate process analysis and subsequently drive actions and improvements
Refine and update the CAPA and Complaint handling process to embrace new regulatory and quality requirements
- Validate key design inputs including usability, reliability, performance, and manufacturability
- Have knowledge of quality design and risk management, including key terms and definitions so that the project teams follow design controls correctly
- Provide quality support and input on development and test of software
- Review and assist in the development of verification and validation protocols and reports
Driving quality improvements in the manufacturing stages:
- Providing Quality oversight on Manufacturing activity
- Implementing and providing oversight of consistent requirements related to technical tools and solutions for utilization in the manufacturing environment
- Attracting, retaining, and developing the team of PQEs
- Preparing the company for audits, assessments and inspections from all accreditation bodies and customers
- A Bachelor or above Engineering Degree or equivalent experience
- Experience of previous team leadership or management
- Substantial experience in a highly regulated industry such as medical device, automotive or aerospace. Experience in Medical Devices industry is desirable.
- Experience with FDA QSR, EU MDR, and ISO 13485 regulations is preferred
- Capable of making decisions concerning containment and disposition of products and product safety issues
- Understanding and experience of problem-solving, root cause analysis, and quality improvement tools and techniques
If you would like to be considered for this role, please apply to send a copy of your full CV – or call us now.
Whilst this position may not be of interest to you or suit your skills and experience, please don’t hesitate to get in contact with a member of the team at Willcox Matthews to understand how we can support you.
We receive a large number of applications for all of our positions – Therefore, If you have not received a response within 10 working days, your application has unfortunately been unsuccessful on this occasion.
Candidates must be eligible to work and live in the UK