Title: Quality Systems Engineer
Job Type: 6 months contract
Salary: £35-£50 per hour
Contact Person: Miss Rashida Khan
Opportunity: Are you currently working as a quality engineer looking for your next role? Have you implemented or maintained a quality management system? Do you have experience in dealing with NCR/CAPA’s and change controls? Looking for your next contract role based working from home with an exciting global medical device company? If yes then this is the role for you.
Your role as a Quality Systems Engineer based working from home will involve being part of the team maintaining the quality management system for the company. Duties and responsibilities include:
- NCR/CAPA – Root cause analysis, monitoring of open NCR/CAPA’s.
- Change control – Monitoring of open change control, raising new change control.
- EQMS – Performing document control activities, including creating, distributing, modifying, storing and reviewing documents and records.
- Post-Market Surveillance activities: Assisting with PMCF plans, PMS data collection, analysis and reporting.
- Managing product vigilance issues, including field safety notices, customer advisory notices and liaison with National Competent Authorities as required.
- Risk Management.
- Data Analysis - Analysing and trending of QMS data.
- Software validation – Writing test cases/executing test cases.
- Helping with Notified body audits.
- Supplier quality assurance development.
This is a 6 months contract role which will be reviewed for a possible extension or go permanent but everything is dependent on the individual and business performance. There will be travel to the site in Walsall, West Midlands as and when needed.
The PAYE rate is anywhere between £35 to £50 per hour dependent on skills and experience.
Skills: To apply for the role of Quality Systems Engineer you will have the following:
- Ideally quality systems engineering experience within medical device industry.
- Notified body audit experience.
- Experience of QMS implementation.
- Excel – Advanced.