Job Description

JOB DESCRIPTION - Cartridge Quality Engineer, Cartridge Engineering

Who We Are:

binx health is a healthcare technology and diagnostics company focused on expanding access to care. The binx io is the world's first FDA-cleared, CLIA-Waived, point-of-care platform for chlamydia and gonorrhea testing in both males and females. Our rapid, molecular platform brings rapid, accurate and convenient infectious disease testing to clinical settings nationwide. Our solutions have the ability to broaden access to care for millions and put proprietary testing solutions in the hands of clinicians everywhere. We work with universities, hospitals, clinics, public health departments, k-12 schools, employers and other organizations to provide patient-centric solutions for their communities.

Our Values:

We are...

B

old - Tenac

i

ous - O

n

e Team - Fi

x

ated on Our Mission




At binx health, we know a diverse workforce adds to our collective value and strength as an organization. People of colour, the LGBTQIA+ community, disabled candidates and veterans are strongly encouraged to apply. binx health is proud to be an Equal Opportunity Employer, committed to equal employment opportunity and fair, equitable compensation regardless of race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

The Position:

The Cartridge Quality Engineer (C QE) acts as an authority in the engineering team to cover quality activities and liaise with the QA/RA department. 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.




Responsibilities:

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 management and support to contract manufacturers: + Manage ongoing change managements and coordinate change updates
+ Lead root cause investigation activities and drive continuous improvements
+ Non-conformance management
+ Data trending
+ Assessing need for CAPA
+ CAPA investigation and activity closure
+ Validation documentation review and approval
+ Complaint investigations/trends
+ Audit support
+ Manage SCARs with manufacturer, ensure closeout in 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 optimised for volume and cost reduction Analysis of manufacturer performance, identifying opportunities for improvement Key liaison with contract manufacturer



Education, Experience and Demonstrated Skills:

REQUIRED

A relevant Bachelor's degree in an engineering discipline or equivalent medical device experience. Knowledge of the development of Process Validation Knowledge of managing change management processes Risk Management experience. CAPA and Non-Conformance Report experience Supplier corrective actions reporting

DESIRABLE

Design Verification Risk Management for Medical devices experience Material and process characterisation Experience in an ISO 13485 environment for FDA or EMA 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 device General understanding of 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 Solidworks.