Director of QA
Monmouth Junction, NJ Monmouth Junction, NJ Full-time Full-time Estimated:
$118K - $149K a year Estimated:
$118K - $149K a year 4 hours ago 4 hours ago 4 hours ago 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.
Working with the Clinical Laboratory Director(s), the Quality Assurance Director will be responsible for creating and maintaining a Quality plan and quality management system (QMS) which will be compliant with CLIA, CAP.
NYSDOH, and FDA (whenever applicable) guidance and standards.
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.
Provides QA expertise to the laboratory and as needed, serves as the liaison to external governing entities.
The Quality Assurance Director ensures that the laboratory and the laboratory staff follow all laws and regulations that are required by CLIA, CAP, OSHA and NYSDOH and any other applicable legislative organizations, and raise any related issues to the upper management in real time.
In addition to performing the role by him/herself.
, the Quality Assurance Director will oversee a QA team and work cooperatively to integrate and maintain an efficient QMS, provide all needed training and make the organization inspection ready at any moment.
Responsibilities Develop and implement a quality strategic plan for the 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 QA leadership/mentorship for QA team and cross-functionally.
Ensure QMS areas are adequately supported and resourced.
Partnering with the lab director(s) and other stakeholders, develop and implement policies and procedures and train lab staff on them.
Maintain company compliance to CAP/CLIA regulations for LDT, NYSDOH and other state regulation and 21 CFR 820 when applicable.
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 so that evidence is generated, essentially that plans are created, assessed, reviewed, and issues are mitigated as appropriate.
Provide leadership and support for any internal, customer, regulatory body, or health authority audits/inspections.
Lead and/ or support compilation and articulation of nonconformances with the implementation of best-practice corrective action and preventive action plans (CAPAs) to bring any issue to resolution as fast as practical.
Oversee and drive 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.
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 check lists and proactive observation.
Prioritize responsibilities, anticipates problems, and provides timely and appropriate solutions.
Able to act as a liaison with other operational areas to get an QA issues resolved.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
$118K - $149K a year Estimated:
$118K - $149K a year 4 hours ago 4 hours ago 4 hours ago 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.
Working with the Clinical Laboratory Director(s), the Quality Assurance Director will be responsible for creating and maintaining a Quality plan and quality management system (QMS) which will be compliant with CLIA, CAP.
NYSDOH, and FDA (whenever applicable) guidance and standards.
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.
Provides QA expertise to the laboratory and as needed, serves as the liaison to external governing entities.
The Quality Assurance Director ensures that the laboratory and the laboratory staff follow all laws and regulations that are required by CLIA, CAP, OSHA and NYSDOH and any other applicable legislative organizations, and raise any related issues to the upper management in real time.
In addition to performing the role by him/herself.
, the Quality Assurance Director will oversee a QA team and work cooperatively to integrate and maintain an efficient QMS, provide all needed training and make the organization inspection ready at any moment.
Responsibilities Develop and implement a quality strategic plan for the 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 QA leadership/mentorship for QA team and cross-functionally.
Ensure QMS areas are adequately supported and resourced.
Partnering with the lab director(s) and other stakeholders, develop and implement policies and procedures and train lab staff on them.
Maintain company compliance to CAP/CLIA regulations for LDT, NYSDOH and other state regulation and 21 CFR 820 when applicable.
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 so that evidence is generated, essentially that plans are created, assessed, reviewed, and issues are mitigated as appropriate.
Provide leadership and support for any internal, customer, regulatory body, or health authority audits/inspections.
Lead and/ or support compilation and articulation of nonconformances with the implementation of best-practice corrective action and preventive action plans (CAPAs) to bring any issue to resolution as fast as practical.
Oversee and drive 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.
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 check lists and proactive observation.
Prioritize responsibilities, anticipates problems, and provides timely and appropriate solutions.
Able to act as a liaison with other operational areas to get an QA issues resolved.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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