Quality Assurance Manager, US
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 fast lab solutions, 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
Quality Assurance Manager, US - this role can be based remotely in the US - ideal location would be around the Waltham, MA area
The Quality Assurance Manager is expected to work both independently and with managerial oversight to provide quality assurance expertise across multiple products to support the US business in a global, fast-paced organization. Expected to identify and resolve routine issues and problems, while proactively defining and escalating non-routine issues.
The Quality Assurance Manager provides leadership of quality assurance for LumiraDx North America. Scope includes Supplier Quality and Customer Quality, including post-market compliance activities. Reporting to the VP of Quality & Regulatory Affairs, North America, the Quality Assurance Manager will work collaboratively with the LumiraDx global QA/RA management team as well as other internal and external groups.
Key Roles and Responsibilities
- Responsible for maintaining quality assurance of Supplier Quality and Customer Quality processes for LumiraDx North America within the scope of the business, including post-market quality/regulatory responsibilities.
- Manage LumiraDx Quality Assurance to maintain compliance with the quality system requirements, applicable internal controls and corporate polices.
- Manage areas such as product distribution and product tracking in the field.
- Support complaint investigations and MDR reporting, supplier/distributor audits, and approved vendor/supplier lists.
- Provide quality assurance expertise to the creation and maintenance of customer agreements.
- Manage quality processes related to product returns, recalls, and field actions.
- Perform data analysis to monitor Post Market performance and compliance. Ensure trending is performed and provided to management team as scheduled. Responsible for providing feedback from complaints processes to process owners for continuous improvement.
- May manage and supervise Quality specialists to provide guidance and support in the compliance of regulatory and LumiraDx requirements.
- Drive continuous improvement of quality assurance and quality controls practices.
- Bachelor’s degree in scientific or technical discipline.
- Proven track record of increasing responsibility in medical device quality assurance, preferably in IVD devices with significant experience in a management position.
- Advanced degree in scientific or technical discipline.
- Knowledge of and experience in point of care diagnostic instrumentation
- Formal training in quality and/or regulatory affairs with certification (e.g. CQA, QSQ, RAC)
- Highly proficient with Microsoft Office, database tools and electronic QMS tools.
- Excellent written and oral communication skills.
- Highly organized with strong attention to details.
- Experience managing product recalls, field actions
- Experience with MDR reporting
- Experience with complaint handling, investigation summaries
For further information and to apply for this role, please click APPLY