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Production Quality Assurance Specialist
1 month ago
About Surgical Innovations Ltd
We are a leading UK manufacturer of medical devices, dedicated to designing, developing, and manufacturing high-quality, precision-engineered instruments for minimally invasive surgery. Our success is built on our people, and we value our collaborative and dynamic work environment, inclusive culture, and commitment to individual development and growth.
About the Position
We are seeking a Production Quality Engineer to support the introduction of new and improved 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 to ensure the smooth introduction of new products and processes into production.
Responsibilities
- Carries out change, validation, and risk assessment activities 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 activities 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.
- Assists with the implementation of corrective actions following customer complaints (CAPA) and both internal and external NCRs.
- Supports Quality Control on quality issues, programs, 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
To be successful in this role, you will need 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.