QA Team Lead

Description

Quality Assurance Team Lead

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 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…

Bold – Tenacious – One Team – Fixated 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:

To act as a conduit for the effective operation of the binx QMS. To provide a professional quality assurance support role for the internal organisation, supplier quality interfaces and customer quality interfaces as required.  A Quality professional with a sound practical background in the application of ISO13485 quality principles within the IVD or Medical Devices Industry.

The successful applicant will be able to demonstrate the ability to support the implementation and maintenance of an integrated QMS that meets the requirements of ISO13485 / 21 CFR Part 820 compliance, other regulations, and effective business processes. A self-motivated individual is required as this role will involve working with and across all internal departments. The role may also require communication with suppliers and customers. 

The ideal applicant will have experience with software validation, either as a stand-alone medical device or incorporated within a medical device.

                Responsibilities:

• Advise and support organizational leaders in furthering the company’s goals.
• Prioritize, assign, and monitor the workload of QA team members.
• Lead and support the implementation of QMS processes
• Act as a system administrator for the eQMS system (QT9)
• Train employees companywide in QMS procedures owned by QA, as required
• Audit processes and QMS procedures for compliance and effectiveness
• Support and advise operational staff in the execution of the QMS processes
• Monitor key performance indicators
• Support the on-going development of the binx Quality Management System and the application of other relevant regulatory requirements
• Provide backup QA team resource for the day-to-day administrative requirements of the quality management system.
• Identify quality improvements and implement efficiencies.

                Education, Experience and Demonstrated Skills:

• BSc in a relevant Scientific discipline, or equivalent experience
• Recognised qualification from a relevant quality institute

• A minimum of 5 years hands-on supporting the development, operation and maintenance of a ISO13485 structured quality management system
• A minimum of 2 years’ hands-on experience in the IVD or medical device industry
• Skilled in collaboration and working in cross-functional groups to achieve positive outcomes
• Experience in process-based auditing
• Strong understanding of ISO13485
• Strong understanding of 21 CFR Part 820
• Basic understanding of IVD Directive (98/79/EC)
• Basic understanding of ISO14971
• Ability to write controlled documents like SOPs
• Ability to train others

• An understanding of the role of quality in a business context
• Strong verbal & written communication
• Ability to operate electronic QMS systems (including document control)
• Working to deadlines
• Attention to detail

• Ability to formulate and ask open-ended questions
• Competent in word processing, spread sheets, databases

Qualifications