Shift Quality Engineer
LumiraDx is a medical technology company developing, manufacturing and marketing smart connected diagnostics and diagnostic-led care solutions. Founded in 2014 by entrepreneurs with a successful track record in building and scaling medical diagnostics and health IT businesses, the company has major operations in the UK and the USA, and is supported by a global sales network, LumiraDx is a high growth organisation. We have recently launched the innovative LumiraDx Platform, and are looking for proactive, experienced, focused and enthusiastic individuals who can make a significant contribution to the continued growth and success of our dynamic and forward-looking company.
Role & Responsibilities
Permanent / Full time – these roles operate 24/7 shifts, 365 days per yearRole Description
- Act as the Quality Engineering representative on shift.
- Product and process performance monitoring.
- Issue resolution of problems occurring on shift using a quality approach and detailed documentation.
- Statistical analysis, trend monitoring and reporting.
- Determine risk and be involved in dispositioning of issues relating to product and process compliance.
- Adhere to all relevant regulatory and quality requirements.
- Engage the production team in the identification of process improvement initiatives to meet quality requirements.
- QA review of records including batch records, quality events, planned deviations, corrective actions, protocols and risk assessments ensuring accuracy and completeness.
- Raise, Investigate, root cause and resolve Non-Conformances / Quality Events.
- Ensure changes to process and specifications meet quality standards and are documented appropriately.
- Working with wider team to develop and improve methods.
- Working with manufacturing/production teams to ensure methods are appropriate and meet requirements.
- Work in collaboration with QA day team to ensure timely communication / resolution of quality issues and progress of batch records through QA review.
- A hands-on Quality Engineer with a high level of relevant industry experience.
- GxP experience.
- Competent in non-conformance root cause investigation and documentation.
- Excellent organizational skills for working on and prioritizing multiple activities.
- Competent IT skills in Excel, PowerPoint, Word and ability to pick up new systems (e.g. document management; complaint; ERP systems).
- Experience of review of quality records.
- Good team worker.
- Knowledge and experience of ISO13485, FDA 21 CFR Part 820, MDSAP.
- Experience of post launch IVD or medical device activities in a quality role.
- Knowledge of problem solving tools and methodologies.
- Continual Improvement mindset (PDCA, Kaizen, Six Sigma, Lean, Value Stream Mapping).
For further information and to apply for this role, please click APPLY