Who We Are
binx health has the world’s fastest FDA-cleared molecular platform for CT/NG testing. We also have the broadest suite of offerings in at-home testing for large corporate partners for broadened access to STI and COVID-19 care. Our molecular point of care platform brings rapid, accurate, and convenient infectious disease testing to people where they live, work and shop. Our at-home solutions offer front-end engagement, and end-to-end logistics in concert with our reference lab partners to offer partners “turn-key” answers for their infectious disease testing needs. Our solutions broaden access to care for millions and put proprietary testing solutions in the hands of clinicians everywhere, including in the ever-expanding footprint of retail health. Our suite of medical guideline-driven, at-home testing solutions for STIs and COVID-19 are designed to reach the many who are unwilling or unable to visit a physical location.
We are looking for a Quality Engineer to join our team at an exciting time of rapid growth. The Quality Engineer acts as an authority in the quality management system requirements and product. The role is diverse and includes non-conformance management, leading CAPA investigations and activity closure, validation documentation review and approvals, complaint investigations/trends, internal and external audits support. You will manage changes that enhance manufacturing quality and drive quality in line with our values and enabling strategic success. Regular site visits to the manufacturing facilities will be required for this role. The Quality Engineer will lead quality improvement activities and suggests innovative solutions to technical problems.
- Plan and execute process validation for existing and new products
- Ensure adherence to product quality requirements at contract manufacturer
- Plan and execute investigations as required for material or process changes
- Provide quality leadership and support to contract manufacturers:
- Lead root cause investigation activities and drive continuous improvements
- Non-conformance management
- Data Trending
- CAPA investigation and activity closure
- Validation documentation review and approval
- Complaint investigations/trends
- Audit support
- Manage SCARs with the manufacturer, ensure closeout in a timely manner and report on corrective actions
- Develop and maintain risk management documentation such as process FMEA
- Work with binx engineering team to maintain consistency of product across manufacturers
- Ensure quality requirements are met as manufacturing is scaled and processes optimized for volume and cost reduction
- Analysis of manufacturer performance, identifying opportunities for improvement
- Key liaison with a contract manufacturer
Education, Experience, and Demonstrated Skills
- A relevant Bachelor's degree in an engineering discipline or equivalent medical device experience.
- Full knowledge of the development of Process Validation
- Risk Management experience.
- CAPA and Non-Conformance Report experience, supplier corrective actions reporting
- Design Verification
- Material and process characterization
- Experience in an FDA and/or ISO 13485 environment
- Root cause Analysis
- Able to develop and analyse KPI data
- DFMEA & PFMEA experience
- Experience in developing and/or the manufacture of products in an IVD diagnostic
- General understanding of molecular biology, focussed on PCR and sample preparation would be beneficial.
- Ability to diagnose and solve technical and/or system problems of a high degree of complexity
- Knowledge of electronic, mechanical and/or computer reengineering design and applications principles
- Knowledge of clinical systems architecture used for medical device interoperability
- Strong level of computer literacy and the use of word processing, spreadsheets, databases, graphics, statistics, engineering tools and programming.CAD – ideally Soldiworks
binx health, Inc. is an Equal Opportunity Employer
For interested applicants, please submit resumes to firstname.lastname@example.org