QA Quality Engineer

3 months ago

Cirencester, United Kingdom Corin Full time

QA Quality Engineer

Corinium Centre, Love Lane Industrial Estate, Cirencester GL7 1YJ, UK Req #278 30 July 2024

Corin is seeking a  QA Quality Engineer within the QA team to continually meet all quality assurance requirements providing exemplary quality engineering support. This is an onsite role based in Cirencester, Gloucestershire. 

The key responsibilities for a QA Quality Engineer are to;

Evaluate the operation of Manufacturing and Quality activities in relation to compliance to Quality Standards and Regulations and recommend where corrections or improvements are indicated. Provide direct support to Quality personnel regarding operation of Quality Assurance function. Provide support to other departmental activities as directed. Experienced in use of statistical and other quality tools for investigation processes, Risk Management and Root Cause Analysis Internal Audit: Understands and has the ability to apply and audit the requirements of ISO 13485 GMP/GDocP- Deliver trainings as desired to Corin employees. Change Control: Originate, review, and approve internal operating procedures and specifications through the Document Change process. Support NCR and CAPA: Corrective/Preventive actions and product non-conformance control including: capturing data and investigations associated with product deviations, product non-conformances, CAPAs, scrap and rework, and analysing the data for the reasons of Quality Improvement and reporting. Conduct, Lead & Support CAPA projects and ensure effective solutions of same Support Product Complaints: Support Product Surveillance through review and ownership of data/trend evaluations and investigations associated with product and patient complaints, analysing the data for the reasons of Quality Improvement and reporting. Take ownership and ensure Quality Dashboard statistics are updated on time to ensure Quality KPI’s and targets are metAdhere to Quality Management System (QMS) requirements in line with Corin’s Good Manufacturing Practice (GMP) as per ISO13485 & FDA21 CFR Part 820. Ensure that process & timeline requirements for Corrective & Preventive Actions (CAPA) are met in accordance with Corin’s Standard Operating Procedures (SOP’s) and in support of Corin’s Global Objectives for CAPA.

As a QA Quality Engineer you will be accountable in:

Influencing and leading - Develop a network of internal resources to facilitate completion of tasks. Individual influence is typically exerted at the peer level. Planning and organizing : Complete daily work to meet established schedule with guidance from supervisor on prioritization of tasks. Driving decision making and making an impact : Exercise authority within pre‐established limits and approval. Failure to achieve results can normally be overcome without serious effect on schedules and programs.

​ The ideal QA Quality Engineer will have / be:

Worked ideally within a medical devise, pharma, aerospace, automotive, health care or similar highly regulated business. Experience with CAPA's, Quality, Root Cause analysis, NCR's, Change Control, Engineering, Quality Assurance, Risk Management and Statistical/Quality tools. A BSc or MSc or HNC / HND (or equivalent) in an Engineering or related discipline - mechanical or biomedical ideally Time served experience in a similar Quality Assurance role. Corin provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

Other details

Pay Type Salary Corinium Centre, Love Lane Industrial Estate, Cirencester GL7 1YJ, UK

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