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Director of Quality Assurance 

About the Organization Acutis (www.Acutis.com) is a specialized medical laboratory that complements its hard science with the soft skills of its support teams. This combination allows practitioners to diagnose and treat with greater confidence and with ease.




At Acutis Diagnostics, we are dedicated to providing accurate and reliable clinical diagnostics services to healthcare providers, patients, and communities. As a leading laboratory specializing in toxicology testing and molecular-based PCR tests, we are committed to delivering timely and precise results that aid in patient care and treatment decisions.



Founded on the principles of thorough, exact, consistent results, Acutis Diagnostics leverages cutting-edge technology and the expertise of our highly skilled team to deliver exceptional service and support to our clients.

We understand the critical role diagnostic testing plays in healthcare, and we prioritize quality and accuracy in every step of our process. Whether it's toxicology screening to detect substance abuse or molecular PCR testing for infectious diseases, we strive for excellence in every test we perform.



Above all, our mission at Acutis Diagnostics is to improve patient outcomes and enhance public health through advanced diagnostic solutions. We are proud to be at the forefront of clinical diagnostics, contributing to the advancement of medicine and the well-being of patients at large.

 
EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.  
Description

Acutis Diagnostics is a growing clinical laboratory with locations in Hicksville, NY and Monmouth Junction, NJ. We pride ourselves on providing expert, accurate and concise results as a product of our highly talented and passionate team of professionals. We believe the team we build today will be the foundation of our future success.

The Director of Quality Assurance will report directly to the Chief Scientific Officer and work closely with senior/executive team while establishing the core QA plan and regulatory compliance environment for the new Laboratory located in NJ, as well as the Standard-of-Care capability already in place in NY. The Director will be working from the NJ location but manage the NY lab QA and staff with frequent visits to NY as needed.

The Qa Director will oversee a QA team and work cooperatively with the lab technical, medical and operation director(s), lab manager(s) and supervisors to integrate and maintain an efficient QMS, provide all needed training and make the organization inspection ready at any moment.

The Director of QA will work with the Clinical Laboratory Director(s), and will be responsible for creating and maintaining a quality plan and quality management system (QMS) which will be compliant with CLIA, COLA, CAP, NYSDOH, and FDA (whenever applicable) guidance and standards, and meet biopharma and medical device companies’ expectations.

The QA Director will ensure that quality standards are being met, and any deviation from an applicable protocol, standard or guideline has been adequately investigated and addressed. Provide QA expertise to the laboratory and, as needed, serve as the liaison to external governing entities. Ensure that the laboratory and the laboratory staff follow all applicable laws, regulations and standards, and raise any related issues to upper management in real time.

Key responsibilities and tasks will include:

Develop and implement a quality strategic plan for the Quality Management System (QMS) to successfully support lab developed tests (LDT) and FDA-approved IVD medical devices including software algorithms intended to provide patient information and support.

Provide leadership and mentorship for QA team and function cross-functionally, while ensuring QMS areas are adequately supported and resourced.

Partner with the lab director(s), mangers, supervisors and other stakeholders to develop and implement policies and procedures and train lab staff on them.

Maintain company compliance to CAP/CLIA regulations/standards for LDT, NYSDOH and other state regulations and 21 CFR 820 when applicable.

Monitor and improve internal and external customer satisfaction through Quality initiatives, establishing QA metrics and process improvement.

Collaborate closely and effectively with R&D and operations to ensure end to end oversight of Quality technical activities, including planning and findings review/mitigation.

Lead and support any internal, customer, regulatory body, or health authority audits/inspections.

Lead and support the compilation and articulation of non-conformances and the implementation of best-practice corrective action and preventive action plans (CAPAs) to bring any issue to resolution as quickly as possible.

Oversee and drive the refinement of training program requirements, document control and supplier quality activities to build in increased effectiveness.

Oversee training and education of Quality throughout the organization and build collaborative relationships with key stakeholders.

First lead the creation of a new Quality Plan, and then collaborate with the Clinical Laboratory Director, Director of Operations and Quality Team to optimize and enforce the Quality Plan as it is written. 

Maintain a state of readiness for inspections, through regular periodic meetings with all department Directors and supervisors, self-inspection checklists and proactive observation. 

Prioritize responsibilities, anticipate problems, and provide timely and appropriate solutions.  

 
Position Requirements

Your background will include:

BSc, MSc, or PhD in Life Science, Medical Technology, Chemistry or Engineering.

NYS CLT License (preferred).

At least 10 years of experience in Quality Assurance implementing and/or maintaining quality management systems in a regulated clinical laboratory or an IVD company.

5+ years of experience in a lab providing services to pharma and biotech companies in clinical trials.

Demonstrated knowledge of all laws and regulations that are required by CLIA, CAP, OSHA and other related legislative and/or state health departments and organizations.

Experience building and leading high performing teams, including direct-report managers.

Demonstrated ability to interact with all levels of colleagues to educate and inform on the utility of the QMS, in turn driving compliance and continuous improvement.

Examples demonstrating focus on ensuring continuous monitoring and process improvement to build collaborative efficiencies.

Prior examples of building a culture of solution-oriented and evidence-based mind-sets with openness for innovative ways of working.

Proven ability to lead cross-functional teams in problem-solving and execution.

Excellent professional communication skills, including verbal, written, and presentation.

Excellent collaboration skills, with the ability to positively influence others.

Computer proficient with multiple software programs, including MS Office Suite, and Laboratory Management Systems. 

If you believe you have the experience above, the desire to participate in creating a new solution-set within the genomic sequencing space, one that marries the best from standards of care and biopharma, then, we are waiting to speak with you

 

 
Full-Time/Part-Time Full-Time  

This position is currently not accepting applications.

To search for an open position, please go to http://AcutisDiagnosticsInc.appone.com



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