Production Quality Specialist

4 weeks ago


Leeds, Leeds, United Kingdom Surgical Innovations Ltd Full time
About the Role

Surgical Innovations Ltd is seeking a highly skilled Production Quality Engineer to support the introduction of new and improve existing Quality and Manufacturing processes.

In this role, you will work collaboratively with Engineering, Manufacturing, Quality Assurance, and Purchasing teams to ensure the smooth introduction of new products/processes and equipment into production.

  • Key responsibilities include equipment and process validation, new product introduction, data generation and analysis, and issue resolution.
  • You will be a self-motivated, self-starter that is able to work under your own initiative, while also working to tight deadlines.
  • Previous experience in regulated manufacturing with exposure to both NPI and validation/verification activities is essential.
  • You will possess strong analytical and problem-solving skills, with the ability to drive change in a fast-paced environment.

Responsibilities

This role will involve carrying out change, validation, and risk assessment activities in support of manufacturing processes, equipment, and software.

  • You will work with a cross-functional team to prepare DOE, IQ, OQ, and PQ & CSV protocols in line with the site validation and project improvement plans.
  • Process and quality data analysis will be a key part of this role, using Minitab and Excel software to support validation and improvement activity and KPI trending.
  • Investigation of complaints, NC, and CAPA will also be a key part of this role, including root-cause analysis, identifying, and implementing permanent solutions.
  • Supporting Quality Control on quality issues, programmes, systems, Gauge R&R, and new product development NPI will also be a key responsibility.

Requirements

To be successful in this role, you will need to demonstrate the qualifications, experience, and skills for the role, including:

  • 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 similar.
  • Strong experience of measurement/inspection activities, including GR&R.
  • A professional attitude and flexible approach to working, with efficient 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.



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