Shift Quality Engineer

Shift Quality Engineer

Permanent / Full time – these roles operate 24/7 shifts, 365 days per year

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.

The Opportunity

The successful candidate shall be responsible for providing Quality Support to the operations team at Dumyat. Activities such as on site QA support, review and approval of documents, batch record review and quality performance monitoring are requirements of this role. Effective working with other LumiraDx quality assurance, reagents, production, engineering, QC and supply chain personnel will be required.

An experienced Quality Engineer who can make a significant contribution to the continued growth and success of our company by providing hands on QA support to the 24/7 operational teams.

As a Shift based Quality Engineer you will support all aspects of the shift production and QC process providing support to Manufacturing, reagents, QC, cartoning and supply chain through process sampling product conformance, maintaining relevant records and monitoring and continuous improvement activities.

Key Roles and Responsibilities

• 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.

About You

We are looking for a highly motivated individual with exceptional attention to detail and high level of skills in problem-solving and communication, along with the following experience:

Essential skills

• 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.

Desirable

• 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).

At LumiraDx, diversity and inclusion are part of who we are. LumiraDx is committed to inclusion across race, colour, religion, age, gender, sexual orientation or identity. We celebrate uniqueness and believe diversity drives innovation. LumiraDx seeks to deliver high quality, affordable medical diagnostics and healthcare services accessible to everyone around the world, and we wish to reflect a global multi-cultural approach across our business

Please note, if you wish to submit an application for this role, please consider the following information

This vacancy is open to internal and external candidates. If you are an internal candidate, please notify your line manager before you submit your application. If you’re successful, you may be subject to all or some of the LumiraDx standard pre-employment checks.

Criminal records data is processed as part of our recruitment and selection processes and, where necessary, in the course of employment, we verify that candidates are suitable for employment or continued employment to comply with legal and regulatory obligations to which the company is subject.

LumiraDx place a high level of importance on its responsibilities for information security and privacy and have put in place an information security management system to ensure that the company and its staff maintain the highest standards with respect to data protection and information security. All staff are responsible for information security and therefore must understand and comply with the Company information security policies, procedures and guidance.