Job Description
About us
For over 30 years, Surgical Innovations have proudly designed, developed and manufactured high quality, precision engineered instruments for minimally invasive surgery and are a leading UK manufacturer of medical devices in its respective field.
Our success is our people and we currently employ over 100 staff from our head office in Leeds. We place great value on our mutually respective relationships, a workplace which is collaborative and dynamic, and a culture which is inclusive and purposeful. The result; a platform for individual development, growth, and prosperity.
As we seek to identify, nurture, and retain talent, we offer competitive benefits packages, continuous training and development opportunities to ensure those joining us on our journey, grow too!
Do you want to be part of an organisation that is leading the evolution in delivering sustainable and innovate solutions which advance healthcare? If so, we want to hear from committed and talented people like you, who share our vision and values to come and join our team.
About the Position
An opportunity has become available for a Production Quality Engineer to support the introduction of new and improve existing Quality and Manufacturing processes. Key activities include equipment and process validation, new product introduction, data generation and analysis and issue resolution.
This role will work collaboratively with Engineering, Manufacturing, Quality Assurance, and Purchasing teams within the business to ensure the smooth introduction of new products/processes and equipment into production.
You will be a self-motivated, self-starter that is able to work under your own initiative, whilst also working to tight deadlines. You will possess previous experience in regulated manufacturing with exposure to both NPI and validation/verification activities. You must enjoy driving change in a fast paced environment whilst working to stringent quality standards.
Responsibilities
On a day to day basis your new role will involve:
* Carries out change, validation and risk assessment activity in support of manufacturing processes, equipment and software.
* Working with a cross functional team prepares DOE, IQ, OQ and PQ & CSV protocols in line with the site validation and project improvement plans.
* Complete process and quality data analysis to support validation and improvement activity and KPI trending using Minitab and Excel software
* Supports Quality with investigation of complaints, NC and CAPA. Carrying out root-cause analysis, identifying and implementing permanent solutions
* Assisting with the implementation of corrective actions following customer complaints (CAPA) and both internal and external NCR’s.
* Supports Quality Control on quality issues, programmes, systems, Gauge R&R etc
* Supports new product development NPI – to facilitate on time and budget delivery of projects and transfer into manufacturing.
* Oversees and/or performs parts critical measurements
* Runs detailed mechanical test programs and produce fully auditable technical reports.
* Adheres to good documentation practice and actively contribute to maintaining Technical Files, Design History Files (DHRs) and Device Master Records (DMRs).
* Support the management of the calibration system
Requirements
To be successful in this role you will need to be able to demonstrate the qualifications, experience and skills for the role:
* Experience of creation, generation and approval of robust documentation and specifications associated with validations
* Experience of Process and Product Improvement and Validation within regulated environments ideally Medical Device or, automotive, oil & gas, aerospace, pharmaceutical industries.
* Strong experience of measurement/inspection activities.
* Experience with GR&R
* Professional attitude and flexible approach to working
* Efficient, with great attention to detail, and commercial awareness of project deadlines.
What we offer
This position offers a competitive salary of £35-£38,000, accompanied by a range of benefits including flexi time, pension, life assurance, income protection, health cash plan, high street discount scheme, and bonus scheme.
If this sounds interesting and the right challenge for you, we look forward to receiving your application!