Quality Engineer - Cirencester, UK
Corin, United Kingdom
Job Description
Corin, an orthopaedic medical device business, are currently looking for a QA Quality Engineer within the QA team to continually meet all quality assurance requirements providing exemplary quality engineering support.
You will work within the QA team based in our global head office in Love Lane, Cirencester, Gloucestershire, which is the home to nearly 400 employees. Corin provides a progressive and dynamic work environment where you can take control of your career, be accountable and drive positive change.
Corin is going through an exciting period of growth with our investment partner Permira committed to driving global technological / robotic advancements in the implant of hip and knee surgery which in turn delivers better patient and surgical outcomes.
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 preestablished limits and approval. Failure to achieve results can normally be overcome without serious effect on schedules and programs.
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.
- 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 amp; 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 met
- Adhere to Quality Management System (QMS) requirements in line with Corin’s Good Manufacturing Practice (GMP) as per ISO13485 amp; FDA21 CFR Part 820.
- Ensure that process amp; timeline requirements for Corrective amp; 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.
- Change Control: Originate, review, and approve internal operating procedures and specifications through the Document Change process.
Requirements
The ideal QA Quality Engineer will:
- Have worked ideally within a medical devises, pharma, aerospace, automotive, health care or similar highly regulated business.
- Have experience with CAPA's, Quality, Root Cause analysis, NCR's, Change Control, Engineering, Quality Assurance, Risk Management and Statistical/Quality tools.
- Hold a BSc or MSc or HNC / HND (or equivalent) in an Engineering or related discipline - mechanical or biomedical ideally
- Have time served experience in a similar Quality Assurance role
Benefits
You will receive a competitive salary and annual bonus as well as;
- 25 days holiday plus bank holidays.
- Excellent pension up to 9.7% provided by Corin when you contribute 4%
- Life assurance (6x basic salary).
- Private medical insurance with BUPA for you and your family.
- Subsidised canteen and gym membership.
- Free car parking - close to Swindon, A419, Cheltenham, Gloucester and Stroud.
- Friendly and collaborative working environment