Production Quality Assurance Specialist
3 weeks ago
About Surgical Innovations Ltd
We are a leading UK manufacturer of medical devices, with over 30 years of experience in designing, developing, and manufacturing high-quality, precision-engineered instruments for minimally invasive surgery.
Our success is built on our people, and we currently employ over 100 staff from our head office in Leeds. We value our relationships, have a collaborative and dynamic workplace, and an inclusive and purposeful culture.
We offer competitive benefits packages, continuous training and development opportunities, and a platform for individual growth and prosperity.
Our vision is to deliver sustainable and innovative solutions that advance healthcare. We are seeking a talented and committed individual to join our team as a Production Quality Engineer.
Job Summary
We are looking for a self-motivated and self-starting 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.
Responsibilities
- Carries out change, validation, and risk assessment activity in support of manufacturing processes, equipment, and software.
- Prepares DOE, IQ, OQ, and PQ & CSV protocols in line with the site validation and project improvement plans.
- Completes 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. Carries out root-cause analysis, identifies, and implements permanent solutions.
- Assists with the implementation of corrective actions following customer complaints (CAPA) and both internal and external NCRs.
- 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 produces fully auditable technical reports.
- Adheres to good documentation practice and actively contributes to maintaining Technical Files, Design History Files (DHRs), and Device Master Records (DMRs).
- Supports the management of the calibration system.
Requirements
- 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.
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