American Esoteric Laboratories
Director of Quality - Rye Brook, NY
American Esoteric Laboratories, Rye, New York, United States,
Director of Quality - Rye Brook, NY
Job Functions, Duties, Responsibilities and Position Qualifications:Quality is in our DNA, is it in yours?Sonic Healthcare USA (SHUSA)
has an exciting opening for a
Director of Quality
in our
Rye Brook, NY
location.Join our dynamic team as the Director of Quality and lead the charge in maintaining and enhancing our state-of-the-art Quality Management System (QMS) for our cutting-edge clinical and anatomic pathology laboratories. In this pivotal role, you will be at the forefront of ensuring top-tier regulatory accreditation and compliance with organizations like the College of American Pathologists (CAP) and the New York State Department of Health. You will drive continuous improvement initiatives across all departments using innovative techniques like Lean and Six Sigma, while also overseeing critical programs such as document control, internal audits, and non-conforming events management. As a key player in the development of FDA cleared tests and laboratory-developed tests, you will ensure our standards are second to none. Bring your expertise in clinical or anatomic pathology laboratories and collaborate with our leadership team to shape and implement essential quality indicators that set new benchmarks for excellence.Location:
Rye Brook, NYDays:
Monday - FridayFull-time:
Benefit EligibleSalary:
$155-180K (depending on experience)Essential Job Duties:Ensure that all systems, processes and testing procedures are compliant with CAP, CLIA, New York Standards and other federal, state and regulatory agencies’ requirements.Manage all aspects of the Quality Management Department including preparing for inspections, performing mock inspections, coordinating quality improvement programs, recording accurate and complete documentation.Responsible for administering the laboratory document control system.Responsible for creating and maintaining all SOPs related to safety, general laboratory policies, and quality management.Responsible for regulatory and accreditation applications and the creation of corresponding policies and procedures.Conduct laboratory quality improvement meetings and ensure minutes are generated and maintained from each. Follow up on all action items generated from meetings.Function as a resource/subject matter expert for the lab safety officer.Want to help get your resume to the top? Take a look at the qualifications and experience we require:EDUCATION:
B.S. in science-related field (required); Certification as MT, CLS, CT, HT or HLT (ASCP) is desirable; MHA/MBA (preferred)EXPERIENCE:
7+ years of laboratory management and quality management experience required. Previous clinical or anatomic pathology bench experience required. Experience with NYSDOH, CLIA, and CAP required. Experience with state licensure preferred.KNOWLEDGE, SKILLS AND ABILITIES:
The ability to communicate effectively both orally and written. The ability to coordinate multiple resources effectively. Accountable and self-directed. Takes initiative and work independently and within a team. Attention to detail and accuracy.LICENSE/CERTIFICATION (REQUIRED/PREFERRED):
ASQ Lean Six Sigma & ASCP generalist certification preferred. Auditor training preferred.Scheduled Weekly Hours:
40Work Shift:Job Category:
Laboratory OperationsCompany:
Sonic Healthcare USA, IncSonic Healthcare USA is an equal opportunity employer that celebrates diversity and is committed to an inclusive workplace for all employees. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, age, national origin, disability, genetics, veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.About Us
About Sonic Healthcare USA
Sonic Healthcare USA
is a subsidiary of Sonic Healthcare Limited, one of the world's largest medical diagnostic companies, providing laboratory services to medical practitioners, hospitals and community health services, with operations in eight countries, on three continents and providing care to over 100 million patients each year. Sonic Healthcare USA is a leading provider of state-of-the-art laboratory services and pathology practices throughout the USA with eight operating divisions and nearly eight thousand US-based employees, 330 Pathologists and serving over 30 million patients per year. Sonic Healthcare USA operates under a federated business model that emphasizes medical leadership and community-based testing services to provide outstanding quality and service to the doctors and patients that they serve. For more information, visit the Sonic Healthcare website at www.sonichealthcareusa.com.
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Job Functions, Duties, Responsibilities and Position Qualifications:Quality is in our DNA, is it in yours?Sonic Healthcare USA (SHUSA)
has an exciting opening for a
Director of Quality
in our
Rye Brook, NY
location.Join our dynamic team as the Director of Quality and lead the charge in maintaining and enhancing our state-of-the-art Quality Management System (QMS) for our cutting-edge clinical and anatomic pathology laboratories. In this pivotal role, you will be at the forefront of ensuring top-tier regulatory accreditation and compliance with organizations like the College of American Pathologists (CAP) and the New York State Department of Health. You will drive continuous improvement initiatives across all departments using innovative techniques like Lean and Six Sigma, while also overseeing critical programs such as document control, internal audits, and non-conforming events management. As a key player in the development of FDA cleared tests and laboratory-developed tests, you will ensure our standards are second to none. Bring your expertise in clinical or anatomic pathology laboratories and collaborate with our leadership team to shape and implement essential quality indicators that set new benchmarks for excellence.Location:
Rye Brook, NYDays:
Monday - FridayFull-time:
Benefit EligibleSalary:
$155-180K (depending on experience)Essential Job Duties:Ensure that all systems, processes and testing procedures are compliant with CAP, CLIA, New York Standards and other federal, state and regulatory agencies’ requirements.Manage all aspects of the Quality Management Department including preparing for inspections, performing mock inspections, coordinating quality improvement programs, recording accurate and complete documentation.Responsible for administering the laboratory document control system.Responsible for creating and maintaining all SOPs related to safety, general laboratory policies, and quality management.Responsible for regulatory and accreditation applications and the creation of corresponding policies and procedures.Conduct laboratory quality improvement meetings and ensure minutes are generated and maintained from each. Follow up on all action items generated from meetings.Function as a resource/subject matter expert for the lab safety officer.Want to help get your resume to the top? Take a look at the qualifications and experience we require:EDUCATION:
B.S. in science-related field (required); Certification as MT, CLS, CT, HT or HLT (ASCP) is desirable; MHA/MBA (preferred)EXPERIENCE:
7+ years of laboratory management and quality management experience required. Previous clinical or anatomic pathology bench experience required. Experience with NYSDOH, CLIA, and CAP required. Experience with state licensure preferred.KNOWLEDGE, SKILLS AND ABILITIES:
The ability to communicate effectively both orally and written. The ability to coordinate multiple resources effectively. Accountable and self-directed. Takes initiative and work independently and within a team. Attention to detail and accuracy.LICENSE/CERTIFICATION (REQUIRED/PREFERRED):
ASQ Lean Six Sigma & ASCP generalist certification preferred. Auditor training preferred.Scheduled Weekly Hours:
40Work Shift:Job Category:
Laboratory OperationsCompany:
Sonic Healthcare USA, IncSonic Healthcare USA is an equal opportunity employer that celebrates diversity and is committed to an inclusive workplace for all employees. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, age, national origin, disability, genetics, veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.About Us
About Sonic Healthcare USA
Sonic Healthcare USA
is a subsidiary of Sonic Healthcare Limited, one of the world's largest medical diagnostic companies, providing laboratory services to medical practitioners, hospitals and community health services, with operations in eight countries, on three continents and providing care to over 100 million patients each year. Sonic Healthcare USA is a leading provider of state-of-the-art laboratory services and pathology practices throughout the USA with eight operating divisions and nearly eight thousand US-based employees, 330 Pathologists and serving over 30 million patients per year. Sonic Healthcare USA operates under a federated business model that emphasizes medical leadership and community-based testing services to provide outstanding quality and service to the doctors and patients that they serve. For more information, visit the Sonic Healthcare website at www.sonichealthcareusa.com.
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